Ultrasound-guided supraclavicular brachial plexus block versus intravenous regional anaesthesia for the manipulation of fractures of the distal radius
| ISRCTN | ISRCTN08332539 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN08332539 |
| Secondary identifying numbers | V 2.0 |
- Submission date
- 28/05/2010
- Registration date
- 31/08/2010
- Last edited
- 18/04/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Thomas Locker
Scientific
Scientific
Emergency Department
Barnsley Hospital NHS Foundation Trust
Gawber Road
Barnsley
S75 2EP
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 |
| Study acronym | SCivi |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/10/2010 |
| Completion date | 01/10/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 68 |
| Key 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 |
| Key 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. |
| Date of first enrolment | 01/10/2010 |
| Date of final enrolment | 01/10/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Barnsley Hospital NHS Foundation Trust
Barnsley
S75 2EP
United Kingdom
S75 2EP
United Kingdom
Sponsor information
Barnsley Hospital NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Gawber Road
Barnsley
S75 2EP
England
United Kingdom
| Website | http://www.barnsleyhospital.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/00yx91b22 |
Funders
Funder type
Government
Barnsley Hospital NHS Foundation Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
18/04/2017: No publications found, verifying study status with principal investigator.
