Condition category
Circulatory System
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
06/11/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Nick Hickey

ORCID ID

Contact details

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

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes