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Anaesthesia for treating distal radial fracture in adults

  1. Helen HG Handoll1,*,
  2. Rajan Madhok2,
  3. Chris Dodds3

Editorial Group: Cochrane Bone, Joint and Muscle Trauma Group

Published Online: 22 JUL 2002

Assessed as up-to-date: 5 JAN 2004

DOI: 10.1002/14651858.CD003320


How to Cite

Handoll HHG, Madhok R, Dodds C. Anaesthesia for treating distal radial fracture in adults. Cochrane Database of Systematic Reviews 2002, Issue 3. Art. No.: CD003320. DOI: 10.1002/14651858.CD003320.

Author Information

  1. 1

    University of Teesside, Centre for Rehabilitation Sciences (CRS), Research Institute for Health Sciences and Social Care, Middlesborough, Tees Valley, UK

  2. 2

    University of Manchester, Cochrane Bone, Joint and Muscle Trauma Group, Manchester, UK

  3. 3

    James Cook University Hospital, Sleep Disorders Clinic, Middlesbrough, UK

*Helen HG Handoll, Centre for Rehabilitation Sciences (CRS), Research Institute for Health Sciences and Social Care, University of Teesside, School of Health and Social Care, Middlesborough, Tees Valley, TS1 3BA, UK. h.handoll@tees.ac.uk. H.Handoll@ed.ac.uk.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 22 JUL 2002

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Characteristics of included studies [ordered by study ID]
Abbaszadegan 1990

MethodsMethod of randomisation: not stated
Assessor blinding: no mention
Intention-to-treat: no information
Loss to follow-up: no data


ParticipantsDanderyd Hospital, Danderyd, Sweden
99 patients participated
Inclusion criteria: displaced Colles' fracture.
Exclusion criteria: shortening 5+mm, hypertension.
Classification: Older, Frykman
sex: 88 female (89%)
age: mean 64 years; range 21-86 years
Assigned: 50/49 [Regional IV/local]
Assessed: ?/? (24 weeks)


InterventionsTiming of intervention: After initial X-ray and before reduction.
a. Regional intravenous block: 3mg prilocaine/kg.
b. Local anaesthesia into fracture haematoma: 15-20ml prilocaine.
All patients treated in a below-the-elbow cast for 4 weeks.


OutcomesLength of follow-up: 24 weeks (6 months); also post reduction, 10-12 days, 1, 2 and 3 months.
a. Efficacy of anaesthesia: pain (VAS)
b. Anatomical: radial shortening, dorsal angulation, redislocation
c. Adverse effects: no mention
d. Clinical: complications: median nerve compression (operation), tendon rupture (patient had rheumatoid arthritis)
e. Functional: grip strength, range of motion, pain
f. Resource: no mention


NotesAnaesthesia given by: no information, probably orthopaedic surgeons.

Request for further details of the trial sent 01/10/01.


Risk of bias

ItemAuthors' judgementDescription

Allocation concealment?UnclearB - Unclear

Blyth 1995

MethodsMethod of randomisation: not stated
Assessor blinding: no
Intention-to-treat: likely
Loss to follow-up: none


ParticipantsGlasgow Royal Infirmary, Glasgow, UK
100 patients participated
Inclusion criteria: distal radial metaphyseal fracture requiring manipulation under Bier's block.
Exclusion criteria: none provided.
Classification: none
sex: 80% female
age: mean 56 years, range 20-93 years
Assigned: 50/50 [elbow/hand]
Assessed: 50/50 (on completion of procedure)


InterventionsTiming of intervention: Before reduction.
All had Bier's block using a pneumatic double cuff: 40ml prilocaine injected over 90 seconds into:
a. Antecubital fossa (elbow).
b. Dorsum (back) of the hand.


OutcomesLength of follow-up: until completion of procedure.
a. Efficacy of anaesthesia: pain (VAS), time to anaesthesia, failed cannulation, number of manipulations
b. Anatomical: no mention
c. Adverse effects: injection site bleeding/haematoma causing problems in application of plaster, none systemic
d. Clinical: complications: no record
e. Functional: no mention
f. Resource: no mention


NotesAnaesthesia given in an operating room complete with a trained staff and resuscitation equipment. Two medical staff always present, procedure probably by surgeons (A&E).

Request for further details of the trial sent 01/10/01.


Risk of bias

ItemAuthors' judgementDescription

Allocation concealment?UnclearB - Unclear

Bultitude 1972

MethodsQuasi-randomised: by alternation after pilot study of 10 patients given diazepam
Assessor blinding: yes for orthopaedic surgeons assessing quality of reduction
Intention-to-treat: no, 10 in pilot study included in analysis
Loss to follow-up: none


ParticipantsThe Royal Hospital, Wolverhampton, UK
71 patients participated (10 in non-randomised pilot study and 1 fracture remanipulated and included in both groups)
Inclusion criteria: distal radial fracture requiring manipulation.
Exclusion criteria: none provided.
Classification: Colles' (63), Smiths (4), separation of epiphysis (4)
sex: 77% female
age: 9+ years; 7 < 20 years, most >40 years.
Assigned: 40/32 [Diazepam/general]
Assessed: 40/32 (at 6 weeks)


InterventionsTiming of intervention: Before reduction.
a. Single IV dose of Diazepam administered over a period of seconds according to dosage: 20mg (34 patients); 30mg (4 heavy patients); 10mg (9 year old). Treated irrespective of when patient had last eaten. Reduction after 60-90 seconds.
b. General anaesthesia: IV barbiturate then inhalation agents. Delay until 4 hours since last meal.
Fracture reduced and immobilised in a complete below-elbow plaster for 5-6 weeks.


OutcomesLength of follow-up: 5-6 weeks; also during reduction, at discharge and first fracture clinic.
a. Efficacy of anaesthesia: reactions during reduction, delayed reduction, apprehensive of anaesthesia method in future
b. Anatomical: quality of reduction, "slipped" at 6 weeks
c. Adverse effects: rash, injection site pain, vomit, headache, drowsiness or giddy post discharge, other
d. Clinical: complications: blood pressure, pulse, respiratory rate up to 1 hour.
e. Functional: no mention
f. Resource: no mention


NotesAnaesthesia given by: not clear, sedative probably given by surgeon in A&E; general anaesthesia: unknown. Nurse assisted surgeon by observing patient's airway and respiration. Fully equipped anaesthetic trolley to hand.

Request for further details of the trial sent 01/10/01.


Risk of bias

ItemAuthors' judgementDescription

Allocation concealment?NoC - Inadequate

Cobb 1985

MethodsMethod of randomisation: not stated
Assessor blinding: no
Intention-to-treat: no, 17 excluded due to missing data
Loss to follow-up: none but 17 excluded


ParticipantsJohn Radcliffe Hospital, Oxford, UK
100 patients participated
Inclusion criteria: closed Colles' fracture requiring manipulation, age 15+ years, normal sensation and circulation of limb.
Exclusion criteria: diabetes, epilepsy, sickle-cell disease, relevant allergy.
Classification: none
sex: no details
age: no details
Assigned: ?/? [Bier's block/local]
Assessed: 44/39 (on completion of plaster)


InterventionsTiming of intervention: Before reduction.
a. Bier's block: 30-40ml 0.5% prilocaine injected in vein on back of the hand. Use of a double cuff, upper cuff deflated after 20 minutes.
b. Local anaesthesia into fracture cavity and adjacent perioteum, including ulnar styloid: 10ml of 2% lignocaine. Forearm cleansed and sterile gloves used.
Fracture manipulated after 10 minutes in both groups. All patients treated with plaster cast.


OutcomesLength of follow-up: until plaster cast completion.
a. Efficacy of anaesthesia: pain (LAS, duration), effectiveness rated by operator (LAS), duration of procedure, patient wait
b. Anatomical: inadequacy of reduction
c. Adverse effects: none "significant"
d. Clinical: complications: none "significant"
e. Functional: no mention
f. Resource: duration of procedure, staff time


NotesAnaesthesia given by: no information, probably orthopaedic surgeons.

Request for further details of the trial sent 01/10/01.


Risk of bias

ItemAuthors' judgementDescription

Allocation concealment?UnclearB - Unclear

Eastwood 1986

MethodsMethod of randomisation: use of envelopes
Assessor blinding: no
Intention-to-treat: likely
Loss to follow-up: probably none


ParticipantsGeneral Hospital, Birmingham, UK
50 patients participated
Inclusion criteria: closed displaced Colles' fracture.
Exclusion criteria: none provided.
Classification: none
sex: 76% female
age: mean 70.5 years
Assigned: 25/25 [modified/standard]
Assessed: 25/25 (before manipulation)


InterventionsTiming of intervention: Before reduction.
All had Bier's block using 0.6ml/Kg body weight of 0.5% prilocaine injected through cannula in dorsum of hand. Two orthopaedic tourniquets applied to upper arm, arm elevated for 3+ minutes before proximal cuff inflated.
a. A rubber venepuncture tourniquet was applied firmly round the arm immediately proximal to fracture site before prilocaine injection. The venepuncture tourniquet was removed before the plaster back slab was applied. The more distal of the two upper arm tourniquets was inflated and then upper cuff deflated.
b. Prilocaine injection alone. Standard Bier procedure.
Fractures were then manipulated (manual manipulation, distraction by 2 people) and a plaster back slab applied. At 5-10 days, a below-elbow plaster cast for 5 weeks.


OutcomesLength of follow-up: until manipulation.
a. Efficacy of anaesthesia: time to reach anaesthesia (loss of perception of pin prick at the fracture site).
b. Anatomical: no mention
c. Adverse effects: none recorded
d. Clinical: complications: no record
e. Functional: no mention
f. Resource: no mention


NotesAnaesthesia given by: anaesthetist senior registrars (2 involved). Orthopaedic senior registrars and consultant also involved.

Standard deviations calculated from frequency diagrams presented in the trial report.

Further details (method of randomisation, no adverse outcomes, details of who provided the care) received via Mr Porter on 04/02/02.


Risk of bias

ItemAuthors' judgementDescription

Allocation concealment?UnclearB - Unclear

Erlacher 2001

MethodsMethod of randomisation: computer-generated randomisation list (placebo controlled, double-blinded)
Assessor blinding: not stated, but blinding likely
Intention-to-treat: likely
Loss to follow-up: none probably


ParticipantsHospital Lainz, Vienna, Austria
57 of the 120 participants had distal radial fractures
Inclusion criteria: Undergoing surgery of forearm or hand after trauma, ASA score 1, 2 or 3, written informed consent.
Exclusion criteria: See above.
Classification: none
sex: (of 57) 39 female (65%)
age: (of 57) mean 52.5 years
Assigned: 9/11/8/7/10/12 (distal radial fractures); 20/20/20/20/20/20 (overall) [Mc/Mo/Rc/Ro/Bc/Bo - see Interventions]
Assessed: same as assigned (recovery from anaesthesia)


InterventionsTiming of intervention: Before surgery.
All had axillary perivascular brachial plexus block according to Winnie; use of nerve stimulator.
a. Clonidine (0.15mg in 1ml) + 40ml mepivacaine (1%) [Mc]
b. 40ml mepivacaine (1%) + 1ml NaCl (0.9%) [Mo]
c. Clonidine (0.15mg in 1ml) + 40ml ropivacaine (0.75%) [Rc]
d. 40ml ropivacaine (0.75%) + 1ml NaCl (0.9%) [Ro]
e. Clonidine (0.15mg in 1ml) + 40ml bupivacaine (0.5%) [Bc]
f. 40ml bupivacaine (0.5%) + 1ml NaCl (0.9%) [Bo]
Distal radial fracture patients had open reduction and internal fixation.


OutcomesLength of follow-up: to recovery from anaesthesia.
a. Efficacy of anaesthesia: Extent and onset of sensory block (VAS), duration of motor blockade
b. Anatomical: no mention
c. Adverse effects: none (hypotension, nausea, vomiting)
d. Clinical: no mention
e. Functional: no mention
f. Resource: no mention


NotesAnaesthesia given by: not stated; named trialists were based in anaesthetics department.

Separate results data for distal radial fracture patients received from Dr Erlacher on 18/11/01.


Risk of bias

ItemAuthors' judgementDescription

Allocation concealment?UnclearB - Unclear

Esmaoglu 1995

MethodsMethod of randomisation: not clear. Trials stated that "patients were randomly assigned according to operation type"
Assessor blinding: not stated
Intention-to-treat: likely
Loss to follow-up: none probably


ParticipantsHospital in Turkey
17 out of 40 patients had distal radial fracture
Inclusion criteria: Forearm/wrist fracture requiring reduction. ASA score 1 or 2.
Exclusion criteria: Raynaud's disease, sclerosis, sickle cell anaemia, large laceration and infection of operated area, myasthenia gravis, degenerative heart disease, liver dysfunction.
Classification: none
sex: not given
age: (of 40) mean 31.5 years, range 18-50 years
Assigned: 9/8 (distal radial fracture); 20/20 (overall) [vecuronium/control]
Assessed: 9/8 (distal radial fracture) 20/20 (overall); (recovery from anaesthesia)


InterventionsTiming of intervention: Before reduction.
All had IV regional anaesthesia with 3mg/kg of lidocaine made up with saline to 40ml and applied over 90 seconds; affected limb drained by elevation and pressure on brachial artery for 2 minutes prior to double tourniquet inflation.
a. 0.5mg vecuronium (muscle relaxant) included in 40ml.
b. Control: lidocaine only.
IV fentanyl applied to patients requiring additional analgesic.


OutcomesLength of follow-up: to recovery from anaesthesia.
a. Efficacy of anaesthesia: 4 point scale including requirement for general anaesthesia. Onset of sensorial & motor block, recovery of sensorial and motor function. Requiring additional analgesic.
b. Anatomical: remanipulation (none)
c. Adverse effects: dizziness, nausea, no others
d. Clinical: no mention
e. Functional: no mention
f. Resource: no mention


NotesAnaesthesia given by: the two named trialists who were based in anaesthetics department.
Translation from Turkish by Dr Murat Genc.
Further details, including some separate data for distal radial fracture patients, of the trial received from Aliye Esmaoglu on 11/12/01. Request for clarification of randomisation method sent 11/12/01.


Risk of bias

ItemAuthors' judgementDescription

Allocation concealment?NoC - Inadequate

Funk 1997

MethodsMethod of randomisation: computer generated, number allocated to patient on arrival to A&E
Assessor blinding: yes for X-rays
Intention-to-treat: no information, questions over numbers randomised/analysed
Loss to follow-up: no data


ParticipantsBolton Royal Infirmary, Bolton, UK
58 (or 59) patients participated
Inclusion criteria: distal radial fracture requiring manipulation, age 16+ years.
Exclusion criteria: analgesia given within 4 hours before manipulation.
Classification: Colles', Smith, other
sex: 52 female (90%)
age: mean 63 years; range 16-91 years
Assigned: 21/19/19 [General/Haematoma block + IV sedation/Haematoma block]
Assessed: ?/?/? (at recovery from anaesthesia)


InterventionsTiming of intervention: At casualty, after initial X-ray and before reduction.
a. General anaesthetic with propofol.
b. Local anaesthetic into fracture haematoma: no more than 2mg/kg of 1% lignocaine injected into site until tight. IV sedation with 1-10mg midazolam - slowly injected until patient was sedated. 5 minutes wait before manipulation.
c. Local anaesthesia into fracture haematoma: as above, no sedation. 5 minutes wait before manipulation.
Intravenous access essential for both groups b & c.
Airway patency, respiration and pulse rates closely monitored. Pulse oximetry, masked oxygen provided. Flumazenil and resuscitation equipment always at hand.


OutcomesLength of follow-up: up to recovery from anaesthesia.
a. Efficacy of anaesthesia: pain (VAS), time for manipulation
b. Anatomical: radial shortening (best guess results), dorsal angulation
c. Adverse effects: none (infection/respiratory depression)
d. Clinical: no mention
e. Functional: no mention
f. Resource: costs (drugs, consumables, staff salaries), wait for staff, total wait for procedure.


NotesAnaesthesia given by: anaesthetist for general anaesthesia, and orthopaedic surgeon for haematoma blocks.
Confirmation from Lennard Funk that this was a randomised trial received 21 August 2001.
Request for further details of the trial sent 18/10/01 & 12/11/01.
Request sent again: 23/06/03


Risk of bias

ItemAuthors' judgementDescription

Allocation concealment?UnclearB - Unclear

Haasio 1990

MethodsMethod of randomisation: not stated
Assessor blinding: no
Intention-to-treat: likely
Loss to follow-up: none


ParticipantsSurgical Hospital, University Central Hospital, Helsinki, Finland
35 patients participated
Inclusion criteria: Colles' fracture up to 6 hours old scheduled for manipulation and reposition. Informed consent.
Exclusion criteria: see above.
Classification: none
sex: 33 female (94%)
age: mean 62 years
Assigned: 16/19 [nerve block/local]
Assessed: 16/19 (during procedure)


InterventionsTiming of intervention: Before reduction.
15ml of 10mg/ml prilocaine used in both groups
a. Conduction block: 5ml doses injected into areas innervated by the radial, median and ulnar nerves in the elbow region. Nerve identified using nerve stimulator and a stimulation-injection needle.
b. Local anaesthesia: injection into fracture haematoma from the dorsum of the wrist.


OutcomesLength of follow-up: until end of procedure
a. Efficacy of anaesthesia: pain (no, moderate, severe), patient satisfaction, relaxation of wrist (enabling reduction), time to start manipulation, pin prick analgesia
b. Anatomical: no mention
c. Adverse effects: none (systemic anaesthetic toxicity)
d. Clinical: complications: no mention
e. Functional: no mention
f. Resource: no mention


NotesAnaesthesia given by anaesthetist.

Request for further details of the trial sent 01/10/01.


Risk of bias

ItemAuthors' judgementDescription

Allocation concealment?UnclearB - Unclear

Hollingworth 1982

MethodsMethod of randomisation: use of random numbers, double-blind, identical drug preparations produced externally, involvement of statistician
Assessor blinding: yes, patient/provider/assessor blinding
Intention-to-treat: no, missing information
Loss to follow-up: 25


ParticipantsQueen's Medical Centre, Nottingham, UK
200 patients participated (142/175 had Colles' or Smith's fractures)
Inclusion criteria: upper limb injury requiring reduction/minor operation, suitable for a Bier's block. Attending A&E.
Exclusion criteria: age <16 years, history of adverse reaction to local anaesthetic agents, history of epilepsy, contraindicated to Bier's block, systolic blood pressure >200mmHg.
Classification: Colles', Smith's, other distal forearm fractures
sex: (of 175) 70% female
age: 16 to 80+ years
Assigned: ?/? [bupivacaine/prilocaine]
Assessed: 85/90 (after end of procedure)


InterventionsTiming of intervention: Before manipulation/operation.
All had Bier's block with a single cuff. Identical injection into dorsum of hand.
a. 40ml of 0.25% bupivacaine (100mg).
b. 40ml of 0.5% prilocaine (200mg).


OutcomesLength of follow-up: after procedure.
a. Efficacy of anaesthesia: quality of reduction/procedure including remanipulation/abandoned procedure (categorical scale: good, acceptable, poor); time to analgesia; pain (doctor, patient, site: injury/cuff); (patient acceptability of Bier's block)
b. Anatomical: quality of reduction (see a)
c. Adverse effects: (all minor), tingling/pain in fingers; metal taste in mouth, tinnitus, feeling nauseous, odd, sweaty
d. Clinical: complications: no record
e. Functional: no mention
f. Resource: no mention


NotesAnaesthesia given by A&E doctors (20 involved).

Of 175 patients:
137 (78%) had Colles' fractures
5 (3%) had Smith's fractures
20 (11%) had hand injuries (fractures/lacerations)
2 (1%) had elbow dislocations
11 (6%) had other distal forearm fractures.

Request for further details of the trial sent 23/10/01.


Risk of bias

ItemAuthors' judgementDescription

Allocation concealment?YesA - Adequate

Jones 1996

MethodsMethod of randomisation: not stated but double-blind
Assessor blinding: likely, patient/provider/assessor blinding
Intention-to-treat: likely
Loss to follow-up: none


ParticipantsBrook General Hospital or Guys Hospital, London, UK
45 patients participated
Inclusion criteria: Uncomplicated Colles' fracture for manipulation under a Bier's block, age > 12 years, in good health, ASA score 1 or 2.
Exclusion criteria: history of gastrointestinal bleeds, asthma, renal impairment, allergy to aspirin or other NSAIDS; currently taking anticoagulants or possibly/actually pregnant.
Classification: none, Colles'
sex: 80% female
age: mean 62 years, range 13-88 years
Assigned: 15/15/15 [tenoxicam in block/tenoxicam opposite arm/control]
Assessed: 15/15/15 (24 hours)


InterventionsTiming of intervention: Before manipulation.
All had Bier's block with 0.5ml/kg of 0.5% prilocaine; affected limb elevated for 2 minutes prior to single cuff inflation. Cannula inserted intravenously into each hand.
a. 2mg tenoxicam (2ml) IV into block and 2ml saline IV into opposite arm.
b. 2mg tenoxicam (2ml) IV into opposite arm and 2ml saline IV into block.
c. Control, prilocaine only (2ml saline IV into affected arm + 2ml saline IV into opposite arm).
Tourniquet release minimum 20 minutes (20-60 minutes).


OutcomesLength of follow-up: 24 hours at fracture clinic.
a. Efficacy of anaesthesia: no mention
b. Anatomical: no mention
c. Adverse effects: none
d. Clinical: pain (time to first analgesic, number of co-dydramol, numeric rating scale, verbal rating category); complications: no mention
e. Functional: no mention
f. Resource: no mention


NotesAnaesthesia given by: not stated; but both named trialists were specialising in anaesthesia (from Department of Anaesthesia).

Request for further details of the trial sent 22/10/01.


Risk of bias

ItemAuthors' judgementDescription

Allocation concealment?UnclearB - Unclear

Kendall 1997

MethodsMethod of randomisation: consecutive computer generated random numbers (randomisation table was not concealed)
Assessor blinding: no for main comparison
Intention-to-treat: no, 8 excluded due to missing data
Loss to follow-up: none but 8 excluded


ParticipantsGloucester Royal Hospital, Gloucester and Bristol Frenchay Hospital, Bristol, UK
150 patients participated
Inclusion criteria: Colles' fracture requiring manipulation, >15 degrees dorsal angulation, >2mm radial shortening, age 16+years.
Exclusion criteria: see above.
Classification: Frykman
sex: (of 142) 125 female (88%)
age: (for 142) mean 63 years
Assigned: ?/? [Bier's/local]
Assessed: 72/70 (at fracture clinic next day)


InterventionsTiming of intervention: After initial X-ray and before reduction.
a. Bier's block: 0.5% prilocaine, volume according to patient's weight.
b. Local anaesthesia into fracture haematoma: 10ml of 1% lignocaine (diluent either sodium bicarbonate (alkalinised) or sodium chloride (not alkalinised)).
All patients had manipulation by distraction of fracture, then palmar flexion and ulnar deviation and forearm placed in incomplete plaster backslab. Fracture clinic next day.


OutcomesLength of follow-up: 3 months (data unavailable); also next day fracture clinic and during procedure.
a. Efficacy of anaesthesia: pain (VAS), timing of various procedural phases
b. Anatomical: radial shortening, dorsal angulation, radial angulation, remanipulation
c. Adverse effects: none (infection, systemic anaesthetic toxicity)
d. Clinical: complications: no mention
e. Functional: no mention (assessed at 3 months - see notes)
f. Resource: no mention, except standard practice: two doctors for Bier's and one for local.


NotesAnaesthesia given by A&E SHOs and registrars from 2 emergency departments (approx. 15 to 20 doctors).

The randomised and blinded comparison of alkalinised versus non-alkalinised lignocaine for haematoma block group is not included in this review.

Report indicated that data collection was ongoing with patients being followed up in "the medium term".

Response from Jason Kendall received 18/10/01. Response from Patricia Allen received 11/12/01 on follow-up study indicated that the numbers available at 3 months meant that "it's almost impossible to draw particularly meaningful conclusions on the final position + function at 3 months".


Risk of bias

ItemAuthors' judgementDescription

Allocation concealment?NoC - Inadequate

London 1996

MethodsMethod of randomisation: not stated, "double-blind"
Assessor blinding: yes, patient/provider blinding
Intention-to-treat: problems, 2 excluded
Loss to follow-up: probably none


ParticipantsDistrict Hospital, Harrogate, UK
33 patients participated
Inclusion criteria: distal radial fracture for manipulation under a haematoma block, informed consent.
Exclusion criteria: none provided.
Classification: none, all Colles'
sex: (of 31) 97% female
age: (of 31) mean 68 years
Assigned: 16/17 [hyaluronidase/control]
Assessed: 14/17 (after manipulation)


InterventionsTiming of intervention: Before manipulation.
All had haematoma block 10ml 1% lignocaine; 8ml injected into haematoma, 2ml around ulnar styloid.
a. 1500IU Hyaluranidase (Hyalase).
b. Control, lignocaine only.
Fractures were manipulated after 10 minutes by one of 2 experienced clinicians.


OutcomesLength of follow-up: after manipulation.
a. Efficacy of anaesthesia: subjective VAS, severity of pain, satisfaction with pain control
b. Anatomical: remanipulation
c. Adverse effects: none
d. Clinical: complications: no record
e. Functional: no mention
f. Resource: no mention


NotesAnaesthesia given by: blinded anaesthetist mentioned.

Request for further details of the trial sent 09/10/01.


Risk of bias

ItemAuthors' judgementDescription

Allocation concealment?UnclearB - Unclear

McGlone 1988

MethodsMethod of randomisation: use of sealed envelopes; trialist stated that allocation was concealed
Assessor blinding: yes, patient/provider/assessor blinding
Intention-to-treat: likely
Loss to follow-up: none


ParticipantsHull Royal Infirmary, UK
36 patients participated
Inclusion criteria: wrist fracture for manipulation under a Bier's block, age < 55 years, informed consent.
Exclusion criteria: none provided.
Classification: none
sex: 69% female
age: not given
Assigned: 18/18 [atracurium/control]
Assessed: 18/18 (after cuff release)


InterventionsTiming of intervention: Before manipulation.
All had Bier's block with 40ml 0.5% prilocaine; affected limb elevated for 3 minutes prior to cuff inflation.
a. 2mg atracurium (muscle relaxant).
b. Control, prilocaine only.
Fractures were manipulated, using simple manual reduction, after 10 minutes by one of 2 experienced clinicians. Followed by short-arm plaster cast.


OutcomesLength of follow-up: after manipulation.
a. Efficacy of anaesthesia: pain (VAS), ease of reduction, failed reduction
b. Anatomical: remanipulation, reduced position
c. Adverse effects: dysaesthesia (sensorial impairment), diplopia (double vision), time to return of fine movement
d. Clinical: complications: no record
e. Functional: no mention
f. Resource: no mention


NotesAnaesthesia given by: 2 A&E doctors

Further details of the trial received from Raymond McGlone 17/10/01.


Risk of bias

ItemAuthors' judgementDescription

Allocation concealment?UnclearB - Unclear

Pippa 2000

MethodsQuasi-randomised: by date of birth
Assessor blinding: stated to be so for anaesthesia, no indication of measures taken
Intention-to-treat: likely
Loss to follow-up: none


ParticipantsCentro Traumatologico, Careggi, Florence, Italy
7 patients of 60 participants had distal radial fracture
Inclusion criteria: undergoing upper limb orthopaedic surgery, ASA class I or II, written consent.
Exclusion criteria: see above.
Classification: none
sex: (of 60) 26 female (43%)
age: (of 60) median 36 years, range 20-65 years
Assigned: 4/3 (distal radial fracture); 30/30 (overall) [proximal cranial needle approach/supraclavicular approach: see interventions]
Assessed: 4/3; 30/30 (after 20 minutes)


InterventionsTiming of intervention: Surgery 2-3 days post fracture. Brachial plexus block at least 30 minutes before surgery.
All patients given diazapam 10mg orally and atropine 0.5mg intramuscularly 20 minutes before starting the brachial plexus block. Anaesthetic was 30ml in equal parts of bupivacaine 0.5% with epinephrine 1:200,000 and lignocaine 2%. Nerve stimulators used in both techniques.
a. Proximal cranial needle approach. Needle inserted via sternocleimastoid muscle at clavicular bone.
b. Winnie and Collins technique involving a supraclavicular approach.
Full details, including diagrams, of the two techniques provided in report.


OutcomesLength of follow-up: 20 minutes post block.
a. Efficacy of anaesthesia: pin-prick analgesia, quality of anaesthesia (categorical scale: excellent, good, insufficient, failure)
b. Anatomical: no mention
c. Adverse effects: pneumothorax, phrenic nerve block with respiratory failure, accidental puncture of subclavian artery (Horner's syndrome was not considered a complication)
d. Clinical: complications: no mention
e. Functional: no mention
f. Resource: no mention


NotesAnaesthesia given by an anaesthetist (Dr Pippa)

Separate data for the 7 distal radial fracture patients provided by Dr P Pippa on 7 October 2001. Further details provided by Dr P Pippa 26 November 2001.


Risk of bias

ItemAuthors' judgementDescription

Allocation concealment?NoC - Inadequate

Singh 1992

MethodsMethod of randomisation: double-blind, computer generated randomisation list, sealed envelopes
Assessor blinding: yes, pain and 8 week assessment
Intention-to-treat: likely; though 1 case excluded due to a failed IV injection at fracture site (inclusion of data from this case reported as not affecting trial results)
Loss to follow-up: none, but 1 excluded from follow-up


ParticipantsTeaching hospital, Lucknow, India
67 patients participated
Inclusion criteria: Colles' fracture requiring manipulation, simple transverse radial fracture within 0.25 inches of the distal articulating surface. Injury duration < 96 hours, informed consent.
Exclusion criteria: contraindication to any method of analgesia, analgesic use during past 8 hours, mental, auditory or visual impairment, associated injury.
Classification: none
sex: (of 66) 20 female (30%)
age: mean 37.5 years
Assigned: 34/33 [sedation/local]
Assessed: 33/33 (8 weeks)


InterventionsTiming of intervention: Before reduction, within 96 hours of injury.
a. Sedation: intravenous injection on dorsum of affected wrist of 30mg pentazocine with 5mg diazepam.
b. Local anaesthesia injected into fracture haematoma: 22cc of 1.5% Xylocaine (anhydrous lignocaine hydrochloride).
Fracture manipulated after 5 minutes in both groups, followed by plaster. Six weeks immobilisation and then 2 weeks institutional physiotherapy.


OutcomesLength of follow-up: 8 weeks; also 13-15 hours post reduction.
a. Efficacy of anaesthesia: pain (VAS), time for reduction
b. Anatomical: reduction failure, non-union, substantial deformity
c. Adverse effects: local sensitivity, significant drug toxicity, infection (none)
d. Clinical: complications: no mention
e. Functional: rest pain, stiffness (substantial = "bothering the patient")
f. Resource: no mention


NotesAnaesthesia given by one of two orthopaedic surgeons. Report notes that anaesthesia facilities would not be available for these patients in developing countries.

All patients tested for Xylocaine sensitivity beforehand.


Risk of bias

ItemAuthors' judgementDescription

Allocation concealment?YesA - Adequate

Walther-Larsen 1988

MethodsMethod of randomisation: not stated
Assessor blinding: yes, radiological and clinical outcome assessment
Intention-to-treat: likely
Loss to follow-up: 6 (4 lost to follow-up and 2 dead)


ParticipantsGentofte Hospital, Copenhagen, Denmark
48 patients participated
Inclusion criteria: closed displaced distal radial fractures, age 14+ years, patient consent.
Exclusion criteria: skin, vessel, tendon lesions, other fracture treated during admission. Other "competing" (as translated) diseases.
Classification: Older
sex: 96% female
age: mean 68.5 years
Assigned: 23/25 [IV regional anaesthesia/local]
Assessed: 21/21 (6 months)


InterventionsTiming of intervention: Before reduction.
a. Intravenous regional anaesthesia: mepivacaine 0.5%, without adrenaline, 40 ml (200mg). Elevation of limb for 5 minutes before cuff inflated and injection.
b. Local anaesthesia into fracture haematoma and at ulnar styloid process: 10ml 2% lignocaine. Disinfection beforehand.
Reduction and immobilisation in low dorsal radial plaster cast.


OutcomesLength of follow-up: 6 months; also 1, 2 and 5 weeks.
a. Efficacy of anaesthesia: pain (VAS)
b. Anatomical: repositioning during anaesthesia, later remanipulation, grade (excellent, good, poor) of reduction/anatomical result (Older 1965)
c. Adverse effects: no systemic or infection
d. Clinical: complications: RSD, nerve complication (median nerve compression, paresthesia, hyposensibility)
e. Functional: grade (excellent, good, poor) including strength, pain, limitation in wrist ROM (Older 1965)
f. Resource: mentioned that IV regional anaesthesia was more time consuming - no indication if recorded


NotesAnaesthesia given by: no information.
Translation from Danish by Dr Steen Barnung

Request for further details of the trial sent 09/10/01. Envelope returned - address unknown in November 2001.


Risk of bias

ItemAuthors' judgementDescription

Allocation concealment?UnclearB - Unclear

Wardrope 1985

MethodsQuasi-randomised: treatments used on alternative days
Assessor blinding: no
Intention-to-treat: no, discrepancies
Loss to follow-up: no data


ParticipantsLeeds General infirmary, Leeds, UK
81 (or more) patients participated
Inclusion criteria: Colles' fracture requiring manipulation, age 45+ years.
Exclusion criteria: previous wrist fracture on injured side, contraindications to Bier's block/local anaesthesia.
Classification: none
sex: no details
age: mean 65 years
Assigned: ?/? [Bier's/local]
Assessed: 45/36 (at fracture clinic discharge); or 42/37 (patient questionnaires)


InterventionsTiming of intervention: Before reduction.
a. Bier's block: 0.5% prilocaine, 0.6ml/kg. Cuff inflated and injection given over 1 minute.
b. Local anaesthesia into fracture haematoma and near ulnar styloid: 1% lignocaine, 0.2ml/kg. Skin cleansed beforehand.
Fracture manipulated after 5 minutes in both groups, followed by padded plaster of Paris backslab. If reduction inadequate, further attempt made during same anaesthetic.


OutcomesLength of follow-up: until discharge from fracture clinic; also after reduction.
a. Efficacy of anaesthesia: pain (VAS and categories), remanipulation during anaesthesia
b. Anatomical: radial shortening, dorsal angulation, ulnar angulation, re-reduction
c. Adverse effects: infection (none)
d. Clinical: complications: swelling, neurological
e. Functional: no mention
f. Resource: time to discharge from fracture clinic


NotesAnaesthesia given by junior staff (A&E department).

Discrepancies in numbers followed up.

Request for further details of the trial sent 09/10/01.


Risk of bias

ItemAuthors' judgementDescription

Allocation concealment?NoC - Inadequate

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Atanassoff 2001Comparison of ropivacaine with lidocaine for IVRA. No patients with fractures of the distal radius.

Bhattacharjee 2000Complex comparison of drugs (bupivacaine (Marcain 0.5% in 10ml) + lignocaine (1% in 10ml) versus lignocaine (1% in 20ml)) in same class. Used for haematoma block in 40+ patients with Colles' fracture.

Brady 1998Indicated as a prospective study in a conference abstract. Contact with lead trialist confirmed that this was not a randomised trial: the first 20 patients had general anaesthetic and the next 20 patients had local anaesthetic.

Chan 2001Indicated as a comparative study of general anaesthesia, IVRA and axillary block. Not a randomised trial - treatment primarily determined by the patient. Also may not include patients with fracture of the distal radius.

Cope 2001Study discontinued after 6 patients. No plans to write up.

Cornish 2001Trialist confirmed that none of the patients had distal radial fractures.

Eerola 1974Comparison of carticaine (Articaine: British National Formulary) with prilocaine for IVRA during upper and lower limb operations. Unknown number of patients with fractures of the distal radius. Incomplete study, which may not have been randomised though double blind. Comparison of drugs in the same class.

James 1994Trialists confirmed that none of the patients had distal radial fractures.

Johansson 1992Study of reduction technique rather than method of anaesthesia.

Kongsholm 1981Study of reduction technique rather than method of anaesthesia.

Kongsholm 1987Study of reduction technique rather than method of anaesthesia.

Loryman 2003Study had received ethical permission but may not have started recruiting before the lead trialist left. It has now been abandoned.

Mouzas 1973Not randomised. Trialist confirmed that anaesthetic method was selected according to patient characteristics; generally general anaesthesia was given to children and when the fracture was badly displaced/impacted, especially in young adults.

Omeroglu 1998Quasi-randomised study of tourniquet use for operative fixation of forearm fractures (closed fractures of the radial and ulna shafts). Inhalation anaesthesia used. No fractures of the distal radius.

Porter 1998Trial not started. The named contact was not sure how the trial, intended to compare haematoma with IVRA, reached the National Research Register as it was being presented to the local ethics committee when she retired.

Quinton 1988Drug (lignocaine) toxicity study only.

Sherry 1989Comparison of drugs (midazolam versus diazepam) in same class. Mixed population including 15 Colles' fractures.

Tan 2001Randomised trial evaluating addition of tramadol to IVRA for upper limb surgery. There were no patients with fractures of the distal radius.

 
Comparison 1. Intravenous regional anaesthesia (IVRA) versus haematoma block

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Pain1Mean Difference (IV, Fixed, 95% CI)Subtotals only

    1.1 During manipulation (VAS: 0 (no pain) to 10 (severe pain))
183Mean Difference (IV, Fixed, 95% CI)-2.89 [-4.35, -1.43]

    1.2 Duration of post-op painlessness (hours)
183Mean Difference (IV, Fixed, 95% CI)-0.30 [-1.59, 0.99]

 2 Pain and preferences1Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    2.1 Number of patients indicating that procedure was painful
179Risk Ratio (M-H, Fixed, 95% CI)0.61 [0.32, 1.13]

    2.2 Numbers with VAS pain rating > 2cm (0 = no pain)
179Risk Ratio (M-H, Fixed, 95% CI)0.64 [0.45, 0.90]

    2.3 Numbers expressing preference for a general anaesthesia
179Risk Ratio (M-H, Fixed, 95% CI)0.70 [0.20, 2.43]

 3 Re-manipulation3271Risk Ratio (M-H, Fixed, 95% CI)0.30 [0.16, 0.57]

 4 Post reduction anatomical measurements1Mean Difference (IV, Fixed, 95% CI)Subtotals only

    4.1 Volar angulation (stated normal 10-15 degrees)
181Mean Difference (IV, Fixed, 95% CI)1.9 [-1.77, 5.57]

    4.2 Ulnar angulation (degrees)
181Mean Difference (IV, Fixed, 95% CI)4.0 [1.43, 6.57]

    4.3 Radial length (stated normal: 12-16 mm)
181Mean Difference (IV, Fixed, 95% CI)1.80 [0.56, 3.04]

 5 Poor quality of reduction and anatomical scores1Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    5.1 Poor reduction result
147Risk Ratio (M-H, Fixed, 95% CI)0.64 [0.33, 1.25]

    5.2 Poor anatomical result (5 weeks)
147Risk Ratio (M-H, Fixed, 95% CI)0.70 [0.35, 1.38]

 6 Later redislocation/re-reduction of fracture3228Risk Ratio (M-H, Fixed, 95% CI)0.32 [0.09, 1.13]

    6.1 Redislocation of fracture
199Risk Ratio (M-H, Fixed, 95% CI)0.11 [0.01, 1.97]

    6.2 Later reduction of redislocated fracture
2129Risk Ratio (M-H, Fixed, 95% CI)0.52 [0.12, 2.23]

 7 Operator judgement of effectiveness of procedure (linear analogue scale)183Mean Difference (IV, Fixed, 95% CI)1.57 [0.43, 2.71]

 8 Timing of procedure1Mean Difference (IV, Fixed, 95% CI)Subtotals only

    8.1 Waiting time for procedure (minutes)
183Mean Difference (IV, Fixed, 95% CI)22.0 [2.74, 41.26]

    8.2 Duration of procedure (minutes)
183Mean Difference (IV, Fixed, 95% CI)0.80 [-3.76, 5.36]

 9 Adverse effects/Complications4Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    9.1 Infection
3271Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    9.2 Systemic complications
2190Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    9.3 Median nerve compression
2147Risk Ratio (M-H, Fixed, 95% CI)0.72 [0.15, 3.58]

    9.4 Other nerve problems: parathesias / hyposensibility
148Risk Ratio (M-H, Fixed, 95% CI)1.09 [0.07, 16.39]

    9.5 RSD
148Risk Ratio (M-H, Fixed, 95% CI)1.09 [0.07, 16.39]

    9.6 Tendon rupture
199Risk Ratio (M-H, Fixed, 95% CI)2.94 [0.12, 70.50]

 10 Poor functional score142Risk Ratio (M-H, Fixed, 95% CI)0.33 [0.08, 1.47]

 
Comparison 2. Nerve block (at elbow) versus haematoma block

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Pain (moderate or severe) during procedure135Risk Ratio (M-H, Fixed, 95% CI)1.78 [0.81, 3.93]

 2 Poor wrist relaxation during procedure135Risk Ratio (M-H, Fixed, 95% CI)0.39 [0.02, 9.01]

 
Comparison 3. Intravenous sedation versus haematoma block

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Pain during reduction: visual analogue scale (0: no pain to 10: excruciating pain)166Mean Difference (IV, Fixed, 95% CI)5.55 [4.50, 6.60]

 2 Pain during reduction: VAS score > 3 for procedure (0: no pain; 10: excruciating pain)166Risk Ratio (M-H, Fixed, 95% CI)4.0 [2.18, 7.33]

 3 Time for fracture reduction1Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    3.1 Time: 1 minute or over
166Risk Ratio (M-H, Fixed, 95% CI)1.28 [1.05, 1.57]

    3.2 Time: 5 minutes or over
166Risk Ratio (M-H, Fixed, 95% CI)1.38 [0.90, 2.11]

 4 Radiological result at 8 weeks1Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    4.1 "Reduction failure"
166Risk Ratio (M-H, Fixed, 95% CI)2.0 [0.39, 10.18]

    4.2 Substantial deformity
166Risk Ratio (M-H, Fixed, 95% CI)0.75 [0.29, 1.92]

    4.3 Non union
166Risk Ratio (M-H, Fixed, 95% CI)Not estimable

 5 Adverse effects1Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    5.1 Local sensitivity
166Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    5.2 Significant drug toxicity
166Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    5.3 Infection
166Risk Ratio (M-H, Fixed, 95% CI)Not estimable

 6 Substantial rest pain at 8 weeks166Risk Ratio (M-H, Fixed, 95% CI)1.67 [0.43, 6.41]

 7 Substantial stiffness at 8 weeks166Risk Ratio (M-H, Fixed, 95% CI)1.75 [0.57, 5.42]

 
Comparison 4. General intravenous anaesthesia versus haematoma block

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Radial length shortening140Risk Ratio (M-H, Fixed, 95% CI)1.63 [0.66, 4.01]

 2 Residual dorsal deformity140Mean Difference (IV, Fixed, 95% CI)-0.60 [-6.12, 4.92]

 3 Timing of procedure1Mean Difference (IV, Fixed, 95% CI)Subtotals only

    3.1 Total waiting time (minutes)
140Mean Difference (IV, Fixed, 95% CI)300.0 [66.72, 533.28]

    3.2 Waiting time for staff (minutes)
140Mean Difference (IV, Fixed, 95% CI)73.0 [45.66, 100.34]

    3.3 Time for anaesthesia + manipulation (minutes)
140Mean Difference (IV, Fixed, 95% CI)10.2 [4.19, 16.21]

 
Comparison 5. General anaesthesia versus sedation (diazepam)

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Reactions during reduction of fracture1Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    1.1 Recalled reduction
172Risk Ratio (M-H, Fixed, 95% CI)0.42 [0.05, 3.82]

    1.2 Limb movement
172Risk Ratio (M-H, Fixed, 95% CI)0.25 [0.03, 2.03]

    1.3 Delayed reduction due to vigorous reaction
172Risk Ratio (M-H, Fixed, 95% CI)3.73 [0.16, 88.53]

    1.4 Groaned, grimaced or cried out
172Risk Ratio (M-H, Fixed, 95% CI)0.11 [0.04, 0.34]

    1.5 Attempt to withdraw arm during reduction
172Risk Ratio (M-H, Fixed, 95% CI)Not estimable

 2 Quality of initial reduction/redisplaced at 6 weeks1Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    2.1 "Bad" quality initial reduction
168Risk Ratio (M-H, Fixed, 95% CI)3.77 [0.16, 89.47]

    2.2 "Slipped" reductions at 6 weeks
168Risk Ratio (M-H, Fixed, 95% CI)0.97 [0.62, 1.50]

 3 Adverse effects1Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    3.1 Precipitous fall in blood pressure and respiratory rate
172Risk Ratio (M-H, Fixed, 95% CI)0.41 [0.02, 9.84]

    3.2 Drowsiness after discharge
172Risk Ratio (M-H, Fixed, 95% CI)1.0 [0.29, 3.42]

    3.3 'Giddy' after discharge
172Risk Ratio (M-H, Fixed, 95% CI)0.25 [0.01, 5.00]

    3.4 Headache
172Risk Ratio (M-H, Fixed, 95% CI)0.41 [0.02, 9.84]

    3.5 Vomiting
172Risk Ratio (M-H, Fixed, 95% CI)6.21 [0.31, 124.97]

    3.6 Injection site pain
172Risk Ratio (M-H, Fixed, 95% CI)0.41 [0.02, 9.84]

    3.7 Rash
172Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    3.8 Felt cold
172Risk Ratio (M-H, Fixed, 95% CI)1.25 [0.08, 19.22]

 4 Patient apprehension if given same method of anaesthesia again1Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

 
Comparison 6. General IV anaesthesia versus haematoma block + sedation (midazolam)

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Radial length shortening140Risk Ratio (M-H, Fixed, 95% CI)2.04 [0.75, 5.54]

 2 Residual dorsal deformity140Mean Difference (IV, Fixed, 95% CI)1.8 [-2.51, 6.11]

 3 Timing of procedure1Mean Difference (IV, Fixed, 95% CI)Subtotals only

    3.1 Total waiting time (minutes)
140Mean Difference (IV, Fixed, 95% CI)240.0 [-11.02, 491.02]

    3.2 Waiting time for staff (minutes)
140Mean Difference (IV, Fixed, 95% CI)76.0 [47.06, 104.94]

    3.3 Time for anaesthesia + manipulation (minutes)
140Mean Difference (IV, Fixed, 95% CI)10.7 [4.34, 17.06]

 
Comparison 7. Location of IVRA injection site: antecubital fossa versus hand dorsum

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Procedural problems and adverse effects1Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    1.1 Patients with "failed cannulations"
1100Risk Ratio (M-H, Fixed, 95% CI)0.33 [0.10, 1.16]

    1.2 Injection site bleeding
1100Risk Ratio (M-H, Fixed, 95% CI)0.09 [0.01, 1.60]

    1.3 Injection site haematoma
1100Risk Ratio (M-H, Fixed, 95% CI)0.09 [0.01, 1.60]

    1.4 Plaster cast application problems (from injection site bleeding or haematoma)
1100Risk Ratio (M-H, Fixed, 95% CI)0.05 [0.00, 0.79]

    1.5 Systematic toxicity
1100Risk Ratio (M-H, Fixed, 95% CI)Not estimable

 
Comparison 8. Application of an additional tourniquet during IVRA

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Time to clinical anaesthesia (minutes)150Mean Difference (IV, Fixed, 95% CI)-4.16 [-5.21, -3.11]

 
Comparison 9. Brachial plexus block technique: proximal cranial needle (PCN) versus Winnie and Collins (W+C)

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Adverse effects (whole group)1Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    1.1 Pneumothorax
160Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    1.2 Phrenic nerve block with respiratory failure
160Risk Ratio (M-H, Fixed, 95% CI)0.08 [0.00, 1.31]

    1.3 Subclavian artery puncture
160Risk Ratio (M-H, Fixed, 95% CI)0.05 [0.00, 0.87]

 
Comparison 10. Muscle relaxant supplement to IVRA

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Failed reduction/re-manipulation253Risk Ratio (M-H, Fixed, 95% CI)0.2 [0.01, 3.89]

 2 Additional analgesic required117Risk Ratio (M-H, Fixed, 95% CI)0.3 [0.01, 6.47]

 3 Unacceptable reduced position of fracture136Risk Ratio (M-H, Fixed, 95% CI)0.2 [0.01, 3.89]

 4 Duration of tourniquet application (minutes) - whole group140Mean Difference (IV, Fixed, 95% CI)-6.75 [-19.25, 5.75]

 5 Timing of sensorial and motor blockade - whole group1Mean Difference (IV, Fixed, 95% CI)Subtotals only

    5.1 Time to onset of sensorial block (seconds)
140Mean Difference (IV, Fixed, 95% CI)-65.5 [-88.61, -42.39]

    5.2 Time to onset of motor block (seconds)
140Mean Difference (IV, Fixed, 95% CI)-574.5 [-715.23, -433.77]

    5.3 Duration of recovery period from sensorial block (seconds)
140Mean Difference (IV, Fixed, 95% CI)5.0 [-32.38, 42.38]

    5.4 Duration of recovery period from motor block (minutes)
140Mean Difference (IV, Fixed, 95% CI)10.23 [7.84, 12.62]

 6 Adverse effects/Complications2Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    6.1 Diplopia
276Risk Ratio (M-H, Fixed, 95% CI)7.0 [0.39, 126.48]

    6.2 Dizziness +/- nausea
140Risk Ratio (M-H, Fixed, 95% CI)1.0 [0.07, 14.90]

    6.3 Dysaethesia
136Risk Ratio (M-H, Fixed, 95% CI)Not estimable

 
Comparison 11. Analgesic (tenoxicam) supplement to IVRA

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Tourniquet time (minutes)1Mean Difference (IV, Fixed, 95% CI)Subtotals only

    1.1 Tenoxicam into block versus none
130Mean Difference (IV, Fixed, 95% CI)-1.0 [-8.16, 6.16]

    1.2 Tenoxicam into opposite arm versus none
130Mean Difference (IV, Fixed, 95% CI)-4.0 [-11.52, 3.52]

    1.3 Tenoxicam into block versus tenoxicam into opposite arm
130Mean Difference (IV, Fixed, 95% CI)3.0 [-4.45, 10.45]

 2 Time to first analgesia (minutes)1Mean Difference (IV, Fixed, 95% CI)Subtotals only

    2.1 Tenoxicam into block versus none
130Mean Difference (IV, Fixed, 95% CI)332.0 [-36.97, 700.97]

    2.2 Tenoxicam into opposite arm versus none
130Mean Difference (IV, Fixed, 95% CI)69.0 [-262.13, 400.13]

    2.3 Tenoxicam into block versus tenoxicam into opposite arm
130Mean Difference (IV, Fixed, 95% CI)263.0 [-76.05, 602.05]

 3 Number of painkillers (co-dydramol) in 24 hours1Mean Difference (IV, Fixed, 95% CI)Subtotals only

    3.1 Tenoxicam into block versus none
130Mean Difference (IV, Fixed, 95% CI)-3.20 [-4.93, -1.47]

    3.2 Tenoxicam into opposite arm versus none
130Mean Difference (IV, Fixed, 95% CI)-1.4 [-3.24, 0.44]

    3.3 Tenoxicam into block versus tenoxicam into opposite arm
130Mean Difference (IV, Fixed, 95% CI)-1.80 [-3.24, -0.36]

 4 Pain: numerical rating scale (0: no pain to 10: worst imaginable) in 24 hours1Mean Difference (IV, Fixed, 95% CI)Subtotals only

    4.1 Tenoxicam into block versus none
130Mean Difference (IV, Fixed, 95% CI)-2.2 [-3.21, -1.19]

    4.2 Tenoxicam into opposite arm versus none
130Mean Difference (IV, Fixed, 95% CI)-0.30 [-1.60, 1.00]

    4.3 Tenoxicam into block versus tenoxicam into opposite arm
130Mean Difference (IV, Fixed, 95% CI)-1.90 [-3.08, -0.72]

 5 Moderate or severe pain in first 24 hours1Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    5.1 Tenoxicam into block versus none
130Risk Ratio (M-H, Fixed, 95% CI)0.13 [0.02, 0.88]

    5.2 Tenoxicam into opposite arm versus none
130Risk Ratio (M-H, Fixed, 95% CI)0.63 [0.26, 1.47]

    5.3 Tenoxicam into block versus tenoxicam into opposite arm
130Risk Ratio (M-H, Fixed, 95% CI)0.2 [0.03, 1.51]

 
Comparison 12. Sedative (midazolam) supplement to haematoma block

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Radial length shortening138Risk Ratio (M-H, Fixed, 95% CI)0.8 [0.25, 2.53]

 2 Residual dorsal deformity138Mean Difference (IV, Fixed, 95% CI)-2.40 [-6.23, 1.43]

 3 Timing of procedure1Mean Difference (IV, Fixed, 95% CI)Subtotals only

    3.1 Total waiting time (minutes)
138Mean Difference (IV, Fixed, 95% CI)60.0 [-165.91, 285.91]

    3.2 Waiting time for staff (minutes)
138Mean Difference (IV, Fixed, 95% CI)-3.0 [-26.61, 20.61]

    3.3 Time for anaesthesia + manipulation (minutes)
138Mean Difference (IV, Fixed, 95% CI)-0.5 [-3.48, 2.48]

 
Comparison 13. Hyaluronidase (enzyme) supplement to haematoma block

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Unsuccessful manipulation133Risk Ratio (M-H, Fixed, 95% CI)3.18 [0.14, 72.75]

 
Comparison 14. Clonidine supplement to brachial plexus block

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Sensory blockade at 10 minutes (VAS: 0 (complete) to 100 (none))157Mean Difference (IV, Fixed, 95% CI)6.53 [-2.45, 15.51]

    1.1 Mepivacaine
120Mean Difference (IV, Fixed, 95% CI)Not estimable

    1.2 Ropivacaine
115Mean Difference (IV, Fixed, 95% CI)3.0 [-17.25, 23.25]

    1.3 Bupivacaine
122Mean Difference (IV, Fixed, 95% CI)19.0 [2.94, 35.06]

 2 Sensory blockade at 30 minutes (VAS: 0 (complete) to 100 (none))157Mean Difference (IV, Fixed, 95% CI)1.19 [-0.98, 3.36]

    2.1 Mepivacaine
120Mean Difference (IV, Fixed, 95% CI)Not estimable

    2.2 Ropivacaine
115Mean Difference (IV, Fixed, 95% CI)1.0 [-4.07, 6.07]

    2.3 Bupivacaine
122Mean Difference (IV, Fixed, 95% CI)7.0 [1.29, 12.71]

 3 Duration of motor blockade (minutes)157Mean Difference (IV, Fixed, 95% CI)198.84 [166.60, 231.08]

    3.1 Mepivacaine
120Mean Difference (IV, Fixed, 95% CI)233.0 [184.58, 281.42]

    3.2 Ropivacaine
115Mean Difference (IV, Fixed, 95% CI)5.0 [-66.62, 76.62]

    3.3 Bupivacaine
122Mean Difference (IV, Fixed, 95% CI)267.0 [212.82, 321.18]

 
Comparison 15. Bupivacaine versus prilocaine for IVRA

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Pain during procedure1Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    1.1 'Great' pain according to doctor
1169Risk Ratio (M-H, Fixed, 95% CI)0.68 [0.17, 2.77]

    1.2 'Great' pain at fracture site according to patient
1165Risk Ratio (M-H, Fixed, 95% CI)0.84 [0.30, 2.30]

    1.3 'Great' pain at cuff site according to patient
1163Risk Ratio (M-H, Fixed, 95% CI)0.56 [0.20, 1.56]

 2 Unacceptable/poor result1Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    2.1 Remanipulation / abandoned procedure
1173Risk Ratio (M-H, Fixed, 95% CI)0.05 [0.00, 0.92]

    2.2 Not anatomical result / incomplete analgesia/ abandoned procedure
1173Risk Ratio (M-H, Fixed, 95% CI)1.08 [0.83, 1.41]

 3 Adverse effects1Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    3.1 Patients with side effects
1175Risk Ratio (M-H, Fixed, 95% CI)1.76 [0.92, 3.39]

    3.2 Tingling / pain in fingers
1175Risk Ratio (M-H, Fixed, 95% CI)1.21 [0.46, 3.19]

    3.3 Metal taste in mouth
1175Risk Ratio (M-H, Fixed, 95% CI)1.06 [0.07, 16.66]

    3.4 Tinnitus
1175Risk Ratio (M-H, Fixed, 95% CI)11.64 [0.65, 207.35]

    3.5 Feeling 'funny' (nauseous, sweaty etc)
1175Risk Ratio (M-H, Fixed, 95% CI)2.91 [0.96, 8.79]

 
Table 1. Methodological quality assessment scheme

ItemsScoresNotes

1. Was the assigned treatment adequately concealed prior to allocation?3 = method did not allow disclosure of assignment.
1 = small but possible chance of disclosure of assignment or unclear.
0 = quasi-randomised or open list/tables.
Cochrane code (see Handbook): Clearly Yes = A; Not sure = B; Clearly No = C.

2. Were the outcomes of patients who withdrew described and included in the analysis (intention to treat)?3 = withdrawals well described and accounted for in analysis.
1 = withdrawals described and analysis not possible, or probably no withdrawals.
0 = no mention, inadequate mention, or obvious differences and no adjustment.

3. Were the outcome assessors blinded to treatment status?3 = effective action taken to blind assessors.
1 = small or moderate chance of unblinding of assessors, or some blinding of outcomes attempted.
0 = not mentioned or not possible.

4. Were important baseline characteristics reported and comparable?3 = good comparability of groups, or confounding adjusted for in analysis.
1 = confounding small, mentioned but not adjusted for, or comparability reported in text without confirmatory data.
0 = large potential for confounding, or not discussed.
The principal confounders considered were gender, age, type of fracture, type of treatment, existing co-morbidities (cardiac disease, arthritis), prior functional and mental status, and existing complications.

5. Were the patients blind to assignment status after allocation?3 = effective action taken to blind patients.
1 = small or moderate chance of unblinding of patients.
0 = not possible, or not mentioned (unless double-blind), or possible but not done.

6. Were the treatment providers blind to assignment status?3 = effective action taken to blind treatment providers.
1 = small or moderate chance of unblinding of treatment providers.
0 = not possible, or not mentioned (unless double-blind), or possible but not done.

7. Were care programmes, other than the trial options, identical?3 = care programmes clearly identical.
1 = clear but trivial differences, or some evidence of comparability.
0 = not mentioned or clear and important differences in care programmes.
Examples of clinically important differences in other interventions were: differences in reduction method, subsequent treatment (surgery, plaster cast), clinician experience and speciality.

8. Were the inclusion and exclusion criteria for entry clearly defined?3 = clearly defined (including type of treatment).
1 = inadequately defined.
0 = not defined.

9. Were the interventions clearly defined (including who provided the care)?3 = clearly defined interventions are applied with a standardised protocol and care providers identified.
1 = clearly defined interventions are applied but the application protocol is not standardised or care providers identified.
0 = intervention and/or application protocol are poorly or not defined.

10. Were the outcome measures used clearly defined?3 = clearly defined.
1 = inadequately defined.
0 = not defined.

11. Were the accuracy and precision, with consideration of observer variation, of the outcome measures adequate (and were these clinically useful?) - including active follow-up?3 = optimal.
1 = adequate.
0 = not defined, not adequate.

12. Was the timing (e.g. duration of surveillance) clinically appropriate?3 = optimal. (> 1 year)
1 = adequate. (3 months - 1 year)
0 = not defined, not adequate. (< 3 months)

 
Table 2. Summary table of outcomes available for interventions studied within RCTS

InterventionComparatorProcedure<-------------------------------------------------Availableoutcomes--------------------------------------------->Comments

MAIN TYPES(comparison number in review)Adequacy of anaesthesiaAnatomical restoration of fractureAdverse effects associated with interventionClinical outcomesFunctional outcomesResource use

Haematoma blockIVRA (1a.)ManipulationYesYesYesYesYesYesInsufficient evidence overall, but some evidence that haematoma block, whilst quicker and easier to perform, provided poorer analgesia and less satisfactory reduction than IVRA.

Haematoma blockNerve block (elbow) (1b.)ManipulationYesNoYesNoNoNoInsufficient evidence to determine effectiveness of haematoma block compared with nerve block.

Haematoma blockSedation (diazepam) (1c.)ManipulationYesYesYesNoYesNoInsufficient evidence available to establish whether haematoma block is better than sedation. Some evidence that haematoma block gives better analgesia during fracture reduction, but operators may have applied a gentler reduction technique.

Haematoma blockGeneral (IV) (1d.)ManipulationYesYesYesNoNoYesInsufficient evidence available and lack of details on method of general anaesthesia. Some evidence that haematoma block gave poorer pain relief during procedure but was quicker and cheaper to perform.

IVRAHaematoma block (1a.)ManipulationYesYesYesYesYesYesInsufficient evidence but some evidence that IVRA, whilst more labour intensive, provided better analgesia and enabled better and more satisfactory reduction than haematoma block.

Nerve block (elbow)Haematoma block (1b.)ManipulationYesNoYesNoNoNoInsufficient evidence to determine effectiveness of haematoma block compared with nerve block.

Sedation (diazepam)Haematoma block (1c.)ManipulationYesYesYesNoYesNoInsufficient evidence available to establish whether sedation is better than haematoma block. Some evidence that sedation provided less pain relief during fracture reduction, but operators may have applied a more forceful reduction technique.

Sedation (diazepam)General (inhalation) anaesthesia (1e.)ManipulationYesYesYesYesNoNoInsufficient and flawed evidence from dated trial. Inappropriately high dosage of diazepam for elderly patients.

Haematoma block with sedation (midazolam)General (IV) anaesthesia (1f.)ManipulationYesYesYesNoNoYesInsufficient evidence available and lack of details on method of general anaesthesia. Some evidence that haematoma block with sedation was reasonably effective in providing pain relief and cheaper to perform. Sedation resulted in a prolonged recovery time (see below).

General (IV) anaesthesiaHaematoma block (1d.)ManipulationYesYesYesNoNoYesInsufficient evidence available and lack of details on method of general anaesthesia. Some evidence that general anaesthesia gave better pain relief during procedure but involved longer waits and higher procedural costs.

General (inhalation) anaesthesiaSedation (diazepam) (1e.)ManipulationYesYesYesYesNoNoInsufficient and seriously flawed evidence from dated trial. Inappropriately high dosage of diazepam for elderly patients.

General anaesthesiaHaematoma block with sedation (midazolam) (1f.)ManipulationYesYesYesNoNoYesInsufficient evidence available and lack of details on method of general anaesthesia. Some evidence that general anaesthesia was only marginally better at providing pain relief and involved higher procedural costs. However, sedation resulted in a prolonged recovery time (see below).

PHYSICAL TECHNIQUESComparatorProcedureAdequacy of anaesthesiaAnatomical restoration of fractureAdverse effects associated with interventionClinical outcomesFunctional outcomesResource useComments

Antecubital fossa injection site for IVRADorsum of hand injection site (2a.)ManipulationYesNoYesNoNoNoInsufficient evidence to say if alterative injection site is safe or effective. Injection site bleeding/haematoma causing problems with plaster cast application were only recorded in the control group. Interestingly, these outcomes were not reported in other IVRA trials using the usual injection site.

Extra tournique proximal to fracture siteUsual for IVRA (2b.)ManipulationYesNoNoNoNoNoInsufficient evidence to evaluate use of extra tournique for IVRA. Only one outcome - time to achieve clinical anaesthesia - was reported.

Proximal cranial needle approach for brachial plexus blockWinnie and Collins approach using supraclavicular approach (2c.)SurgeryYesNoYesNoNoNoNote should be taken of the potential for serious complications (phrenic nerve block with respiratory failure, accidental puncture of subclavian artery, pneumothorax) of this method. Should this method of anaesthesia be considered, then the new approach appears safer but this needs confirmation.

DRUG ADJUNCTSSupplement to:ProcedureAdequacy of anaesthesiaAnatomical restoration of fractureAdverse effects associated with interventionClinical outcomesFunctional outcomesResource useComments

Muscle relaxant (atracurium; vecuronium)IVRA (3a.)ManipulationYesYesYesNoNoNoInsufficient evidence overall, however, some limited evidence in favour of muscle relaxant during procedure. But also, transient side-effects and prolonged motor blockade.

Analgesic (tenoxicam)IVRA (3b.)ManipulationNoNoYesYesNoNoInsufficient evidence including no evaluation of effects on effectiveness of anaesthesia. However, some evidence that tenoxicam injected directly into the IVRA injection site relieved pain in the first 24 hours.

Sedative (midazolam)Haematoma block (3c.)ManipulationYesYesYesNoNoYesInsufficient evidence available to draw conclusions. The addition of midazolam to haematoma block may enhance pain relief during manipulation, but the implications and extent of the longer recovery times reported for patients given sedation are not known.

Enzyme (hyaluranidase)Haematoma block (3d.)ManipulationYesYesYesNoNoNoInsufficient evidence available to draw conclusions. Given the localised nature of the fracture site and procedure, and the potential for allergic reactions, the use of hyaluronidase is questionable.

ClonidineAxillary brachial plexus block (3e.)SurgeryYesNoYesNoNoNoInsufficient evidence, however, some evidence that clonidine may delay sensory blockade and prolong motor blockade.

ANAESTHETIC AGENTThough one exception was made (4.), comparisons of different anaesthetics are not covered in this review