The value of local infiltration of bupivicaine during Perforate Invaginate (PIN) stripping of the long saphenous vein: a randomised, double-blind, placebo-controlled trial.
| ISRCTN | ISRCTN58431114 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58431114 |
| Protocol serial number | N0274135608 |
| Sponsor | Department of Health |
| Funder | West Suffolk Hospitals NHS Trust (UK) |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 02/07/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr S Walsh
Scientific
Scientific
West Suffolk Hospitals NHS Trust
Hardwick Lane
Bury St Edmunds
IP33 2QZ
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double-blind placebo-controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To determine whether infiltration of the strip tract with local anaesthetic during Perforate Invaginate (PIN) stripping produces a significant reduction in post-operative pain |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Signs and Symptoms: Post-operative pain |
| Intervention | Infiltration of bupivicaine vs placebo |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | bupivicaine |
| Primary outcome measure(s) |
Numerical pain scores at 1, 6 and 24 hours post-operatively. Analgesic consumption in the first 24 hours post-operatively. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/03/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 27 |
| Key inclusion criteria | Patients with sapheno-femoral incompetence documented on duplex scanning who are undergoing elective unilateral sapheno-femoral disconnection and PIN stripping of the long saphenous vein with multiple avulsions. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 04/07/2003 |
| Date of final enrolment | 31/03/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
West Suffolk Hospitals NHS Trust
Bury St Edmunds
IP33 2QZ
United Kingdom
IP33 2QZ
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2007 | Yes | No |
