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ISRCTN
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ISRCTN58431114
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ClinicalTrials.gov identifier
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Public title
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The value of local infiltration of bupivicaine during Perforate Invaginate (PIN) stripping of the long saphenous vein: a randomised, double-blind, placebo-controlled trial.
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0274135608
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Study hypothesis
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To determine whether infiltration of the strip tract with local anaesthetic during Perforate Invaginate (PIN) stripping produces a significant reduction in post-operative pain
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised double-blind placebo-controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Signs and Symptoms: Post-operative pain
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Participants - inclusion criteria
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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.
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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04/07/2003
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Anticipated end date
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31/03/2005
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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Added as of 15/04/2008: 27
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Interventions
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Infiltration of bupivicaine vs placebo
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Primary outcome measure(s)
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Numerical pain scores at 1, 6 and 24 hours post-operatively. Analgesic consumption in the first 24 hours post-operatively.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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West Suffolk Hospitals NHS Trust (UK)
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Trial website
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Publications
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2007 results in http://www.ncbi.nlm.nih.gov/pubmed/18269072
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Contact name
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Dr
S
Walsh
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Address
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West Suffolk Hospitals NHS Trust
Hardwick Lane
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City/town
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Bury St Edmunds
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Zip/Postcode
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IP33 2QZ
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Country
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United Kingdom
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Sponsor
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Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)
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Address
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The Department of Health,
Richmond House,
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2004
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Last edited
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02/07/2009
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Date ISRCTN assigned
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30/09/2004
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