A prospective randomised double-blind controlled trial for efficacy of lignocaine with hyaluronidase as a local anaesthetic for carpal tunnel decompression.
| ISRCTN | ISRCTN61466073 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61466073 |
| Secondary identifying numbers | N0155151587 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 16/04/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
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
Mr D H Sochart
Scientific
Scientific
Department of Orthopaedics
North Manchester General Hospital
Delaunays Road
Crumpsall
Manchester
M8 5RB
United Kingdom
Study information
| Study design | Prospective randomised double-blind controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | A prospective randomised double-blind controlled trial for efficacy of lignocaine with hyaluronidase as a local anaesthetic for carpal tunnel decompression. |
| Study objectives | Does lignocaine with hyaluronidase give a better field of anaesthesia and decrease tissue deformity for carpal tunnel decompression? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Anaesthesia |
| Intervention | Lignocaine with hyaluronidase vs standard practice |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Lignocaine with hyaluronidase |
| Primary outcome measure | Field of anaesthesia and tissue deformity |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 30/04/2004 |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 60 |
| Key inclusion criteria | 60 patients undergoing carpal tunnel decompression |
| Key exclusion criteria | Patients with a known contra-indication to lignocaine or lignocaine hyaluronidase and patients undergoing hand surgery additional to carpal tunnel decompression |
| Date of first enrolment | 30/04/2004 |
| Date of final enrolment | 31/12/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
North Manchester General Hospital
Manchester
M8 5RB
United Kingdom
M8 5RB
United Kingdom
Sponsor information
Department of Health
Government
Government
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
Pennine Acute Hospitals NHS Trust (UK), Own Account, NHS R&D Support Funding
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 |
