A prospective randomised trial of local anaesthetic (LA) with adrenaline on varicose vein surgery
| ISRCTN | ISRCTN77640412 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77640412 |
| Secondary identifying numbers | N0282126753 |
- 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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Adrenaline, local anaesthetic |
| Primary outcome measure | 1. The number of phlebectomies performed, length of procedure and intra-operative blood loss recorded for each leg 2. Bruising above/below knee measured at 1 week post-operatively, cosmetic appearance graded and repeated at 6 weeks |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/10/2000 |
| Completion date | 01/09/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Worcestershire Royal Hospital
Worcester
WR5 1DD
United Kingdom
WR5 1DD
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
Worcestershire Acute Hospitals NHS Trust (UK)
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 |
