Condition category
Injury, Occupational Diseases, Poisoning
Date applied
28/05/2010
Date assigned
31/08/2010
Last edited
28/08/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Thomas Locker

ORCID ID

Contact details

Emergency Department
Barnsley Hospital NHS Foundation Trust
Gawber Road
Barnsley
S75 2EP
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

V 2.0

Study information

Scientific title

Ultrasound-guided supraclavicular brachial plexus block versus intravenous regional anaesthesia for the manipulation of fractures of the distal radius: a randomised controlled trial

Acronym

SCivi

Study hypothesis

Is ultrasound-guided brachial plexus block equivalent to intravenous regional anaesthesia in providing pain relief for the manipulation of fracutres of the distal radius?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Distal radius fractures

Intervention

Intravenous regional anaesthesia:
An intravenous cannula will be placed in the dorsum of the hand of the affected limb and a second cannula placed in the contralateral limb. A suitably sized double cuff tourniquet will be placed around the upper arm over a layer of orthopaedic wool. The limb will be elevated for two minutes and the tourniquet inflated to 80 mmHg above the systolic blood pressure. Following confirmation of the absence of a radial pulse and capillary refill in the fingers the dose of 0.5% prilocaine will be injected via the cannula in the dorsum of the affected hand. The volume injected will be 40 ml for patients weighing less than 70 kg and 50 ml for those 70 kg and over. Once anaesthesia has been confirmed by the absence of pin-prick sensation as outlined below, the manipulation will be performed. The tourniquet will remain inflated for a minimum of 20 minutes from the time of injection.

Supraclavicular brachial plexus block:
The intervention group will undergo an ultrasound-guided brachial plexus block using the following technique: an intravenous cannula will be placed in the non-affected hand. The block will be performed using a sterile technique (sterile gloves, chlorhexidine spray, sterile probe cover). Visualisation of the brachical plexus will be undertaken with a Siemens Acuson X300 ultrasound machine with 10 MHz linear array probe. A view of the subclavian artery and surrounding nerve trunks will be obtained with the probe placed in the supraclavicular fossa in the coronal oblique plane. With the patient supine and the head turned at 45 degrees away from the probe. 1 ml of 1% lignocaine will be infiltrated in the skin at the injection site. A 22 gauge 50 mm short bevelled insulated block needle (Braun, Stimuplex) will be inserted at the lateral edge of the probe. The needle will be guided under direct vision from lateral to medial along the long axis of the probe using an in-plane approach. A total of 20 ml of 1% prilocaine will be injected around the trunks with frequent aspiration to exclude inadvertent intravascular needle placement. Spread of local anaesthetic will be observed in real time. Injection will be into at least two separate areas around the nerve trunks.

Duration will be around 1 hour in total for each intervention. Total duration of follow-up will be until seen in fracture clinic. This will be approximately 3 to 7 days in both arms.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Degree of pain experienced by the patient during manipulation, assessed by a Visual Analogue Scale (VAS) score
2. Overall satisfaction with procedure, assessed by a Visual Analogue Scale (VAS) score
3. Duration from randomisation to completion of the manipulation

Assessed at the end of the manipulation of the fracture, i.e. approximately one hour after entering the trial.

Secondary outcome measures

1. Number of manipulations required
2. Emergency department (ED) length of stay
3. Time from commencing the procedure until discharge
4. Need for subsequent surgical intervention

Assessed at 3 - 7 days.

Overall trial start date

01/10/2010

Overall trial end date

01/10/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged greater than or equal to 18 years, either sex
2. Closed fracture of the distal third of the radius
3. Manipulation of the fracture required in the emergency department as judged by an emergency department middle grade doctor or consultant

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

68

Participant exclusion criteria

1. Confusion (Abbreviated Mental Test [AMT] less than 8)
2. Multiple injuries
3. Pre-existing sensory or motor deficit in the affected limb
4. Allergy to lignocaine or prilocaine
5. Any condition precluding the use of a tourniquet in the affected limb
6. Inability to read English
7. Middle grade doctor or consultant trained in intravenous regional anesthesia (IVRA) and supraclavicular block (SCB) not available
8. Significant pre-existing respiratory impairment (defined as exercise tolerance less than 100 metres on flat ground)
9. Anticoagulation, inherited bleeding disorders or any other known clotting or platelet deficiency or abnormality. The use of anti-platelet medications such as aspirin will not count as a contraindication.

Recruitment start date

01/10/2010

Recruitment end date

01/10/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Emergency Department
Barnsley
S75 2EP
United Kingdom

Sponsor information

Organisation

Barnsley Hospital NHS Foundation Trust (UK)

Sponsor details

Gawber Road
Barnsley
S75 2EP
United Kingdom

Sponsor type

Government

Website

http://www.barnsleyhospital.nhs.uk/

Funders

Funder type

Government

Funder name

Barnsley Hospital NHS Foundation Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes