A randomised controlled trial to compare the efficacy of two methods of local anaesthetic blocks in carpal tunnel decompression surgery
| ISRCTN | ISRCTN54115759 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54115759 |
| Secondary identifying numbers | N0227170359 |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 20/12/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr S Patil
Scientific
Scientific
Ward 34
The James Cook University Hospital
Marton Road
Cleveland
TS4 3BW
United Kingdom
| Phone | +44 (0)1642 850 850 |
|---|---|
| spatil@nhs.net |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Is there any difference in the results of two techniques of local anaesthetic blocks in carpal tunnel surgery with regards to pain during infiltration of the anaesthetic, adequacy of the anaesthesia and duration of anaesthesia? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Carpal tunnel decompression |
| Intervention | 20 patients with bilateral carpal tunnel syndromes would be recruited. Each patient would have one side operated in one setting. The other side would be operated in the next 4-6 weeks. Each patient would have a local anaesthetic block using one technique on one side and the other technique on the other side. The first technique would involve infiltrating the operative site (skin and subcutaneous tissue) with 6ml of 2% lignocaine with a no. 23 needle. The other technique would involve infiltration of 2.5ml of 2% lignocaine into the carpal tunnel followed by infiltration of the remaining 3.5ml into the skin and subcutaneous tissue at the site of the incision. The patient would be unaware of the technique used. The patient would be asked to score the pain felt during the administration of the local anaesthetic block using a verbal pain score. The time taken for complete anaesthesia over the site of the incision would be noted. All the operations would be performed by one of the two surgeons in the trial using a standardised technique. It the patient experiences any pain during the operation, this would be recorded using a verbal pain score. Additional anaesthetic would be administered if needed. The duration of the operation and the tourniquet time would also be noted. These patients would be contacted by telephone the next day and asked about the need of analgesics postoperatively over a period of 24 hours and the pain scores at 0, 2 and 4 hours postoperatively. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Pain during the operation 2. Pain during the administration of the local anaesthetic block 3. Frequency of post operative analgesics needed |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/06/2005 |
| Completion date | 05/07/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 20 |
| Key inclusion criteria | 20 patients - calculated by Dr Arts - statistician at Durham University. Inclusion criteria: all patients with bilateral carpal tunnel syndrome who would need surgical decompression. |
| Key exclusion criteria | 1. Re-do carpal tunnel decompressions 2. Carpal tunnel decompressions requiring general anaesthetic 3. Peripheral neuropathy, vascular insufficiency |
| Date of first enrolment | 01/06/2005 |
| Date of final enrolment | 05/07/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Ward 34
Cleveland
TS4 3BW
United Kingdom
TS4 3BW
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
South Tees Hospitals NHS Trust
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2006 | Yes | No |
