Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0282126753
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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 names
Adrenaline, local anaesthetic
Primary outcome measures
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 trial start date
01/10/2000
Overall trial end date
01/09/2004
Reason abandoned
Eligibility
Participant inclusion criteria
20 - 25 consecutive patients.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
25
Participant exclusion criteria
1. Known adverse reaction to LA and/or adrenaline
2. Failure to give informed consent
Recruitment start date
01/10/2000
Recruitment end date
01/09/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Worcestershire Royal Hospital
Worcester
WR5 1DD
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Worcestershire Acute Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary