A prospective randomised trial of local anaesthetic (LA) with adrenaline on varicose vein surgery
| ISRCTN | ISRCTN77640412 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77640412 |
| Protocol serial number | N0282126753 |
| Sponsor | Department of Health |
| Funder | Worcestershire Acute Hospitals NHS Trust (UK) |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 06/11/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
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 Nick Hickey
Scientific
Scientific
Worcestershire Royal Hospital
Charles Hastings Way
Worcester
WR5 1DD
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To assess the effect of preoperative subcutaneous administration of local anaesthetic (LA) with adrenaline into proposed groin and avulsion sites in limbs of patients undergoing varicose vein surgery. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Varicose veins |
| Intervention | Participants are randomised to preoperative subcutaneous administration of local anaesthetic with adrenaline into proposed groin and avulsion sites. Analysed using Mann-Whitney U test. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Adrenaline, local anaesthetic |
| Primary outcome measure(s) |
1. The number of phlebectomies performed, length of procedure and intra-operative blood loss recorded for each leg |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/09/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 25 |
| Key inclusion criteria | 20 - 25 consecutive patients. |
| Key exclusion criteria | 1. Known adverse reaction to LA and/or adrenaline 2. Failure to give informed consent |
| Date of first enrolment | 01/10/2000 |
| Date of final enrolment | 01/09/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Worcestershire Royal Hospital
Worcester
WR5 1DD
United Kingdom
WR5 1DD
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 |
