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 |
| Protocol serial number | N0155151587 |
| Sponsor | Department of Health |
| Funder | Pennine Acute Hospitals NHS Trust (UK), Own Account, NHS R&D Support Funding |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Prospective randomised double-blind controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Lignocaine with hyaluronidase |
| Primary outcome measure(s) |
Field of anaesthesia and tissue deformity |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
North Manchester General Hospital
Manchester
M8 5RB
United Kingdom
M8 5RB
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
