The value of local infiltration of bupivicaine during Perforate Invaginate (PIN) stripping of the long saphenous vein: a randomised, double-blind, placebo-controlled trial.

ISRCTN	ISRCTN58431114
DOI	https://doi.org/10.1186/ISRCTN58431114
Secondary identifying numbers	N0274135608

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr S Walsh
Scientific

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

Study design	Randomised double-blind placebo-controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Signs and Symptoms: Post-operative pain
Intervention	Infiltration of bupivicaine vs placebo
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	bupivicaine
Primary outcome measure	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 study start date	04/07/2003
Completion date	31/03/2005

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	Added as of 15/04/2008: 27
Key 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.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	04/07/2003
Date of final enrolment	31/03/2005

West Suffolk Hospitals NHS Trust

Bury St Edmunds
IP33 2QZ
United Kingdom

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

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

Government

West Suffolk Hospitals NHS Trust (UK)

No information available

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2007		Yes	No