Condition category
Signs and Symptoms
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
02/07/2009
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

Dr S Walsh

ORCID ID

Contact details

West Suffolk Hospitals NHS Trust
Hardwick Lane
Bury St Edmunds
IP33 2QZ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0274135608

Study information

Scientific title

Acronym

Study hypothesis

To determine whether infiltration of the strip tract with local anaesthetic during Perforate Invaginate (PIN) stripping produces a significant reduction in post-operative pain

Ethics approval

Not provided at time of registration

Study design

Randomised double-blind placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Signs and Symptoms: Post-operative pain

Intervention

Infiltration of bupivicaine vs placebo

Intervention type

Drug

Phase

Not Specified

Drug names

bupivicaine

Primary outcome measures

Numerical pain scores at 1, 6 and 24 hours post-operatively. Analgesic consumption in the first 24 hours post-operatively.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

04/07/2003

Overall trial end date

31/03/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with sapheno-femoral incompetence documented on duplex scanning who are undergoing elective unilateral sapheno-femoral disconnection and PIN stripping of the long saphenous vein with multiple avulsions.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Added as of 15/04/2008: 27

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

04/07/2003

Recruitment end date

31/03/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

West Suffolk Hospitals NHS Trust
Bury St Edmunds
IP33 2QZ
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

West Suffolk 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

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/18269072

Publication citations

  1. Results

    Walsh SR, Waters C, Hall J, Bakar M, Boyle J, Gaunt ME, Long saphenous tunnel infiltration with levobupivicaine reduces rescue analgesia requirements following varicose vein surgery: randomized, double-blind, placebo-controlled trial [ISRCTN58431114]., Phlebology, 2007, 22, 5, 214-218.

Additional files

Editorial Notes