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

Worcestershire Royal Hospital
Charles Hastings Way
Worcester
WR5 1DD
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesTo 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) studiedVaricose veins
InterventionParticipants are randomised to preoperative subcutaneous administration of local anaesthetic with adrenaline into proposed groin and avulsion sites. Analysed using Mann-Whitney U test.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Adrenaline, local anaesthetic
Primary outcome measure1. 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 measuresNot provided at time of registration
Overall study start date01/10/2000
Completion date01/09/2004

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants25
Key inclusion criteria20 - 25 consecutive patients.
Key exclusion criteria1. Known adverse reaction to LA and/or adrenaline
2. Failure to give informed consent
Date of first enrolment01/10/2000
Date of final enrolment01/09/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Worcestershire Royal Hospital
Worcester
WR5 1DD
United Kingdom

Sponsor information

Department of Health
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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan