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ISRCTN
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ISRCTN93526301
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ClinicalTrials.gov identifier
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Public title
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Use of Popliteal Regional Anaesthetic Block in Foot and Ankle Surgery
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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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N0244192219
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Study hypothesis
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To assess the use of local anaesthetic injection near the nerve which supplies the foot and ankle to relieve pain in the early postoperative period.
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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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Prospective randomised double blinded 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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Surgery: Foot and ankle
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Participants - inclusion criteria
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1. Patients at Stepping Hill Hospital having general or spinal anaesthetic for surgery on the forefoot in which two or more toes are involved.
2. Hindfoot surgery
3. Ankle surgery
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Participants - exclusion criteria
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1. Infection at puncture site
2. Systemic infection
3. Neurological damage to limb to be blocked
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Anticipated start date
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20/02/2007
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Anticipated end date
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20/08/2007
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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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39 in each group, total 78
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Interventions
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Intervention arm: Popliteal block.
Control: routine intra-operative systemic analgesia.
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Primary outcome measure(s)
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Pain score on VAS scale
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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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Stockport NHS Foundation Trust
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Trial website
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Publications
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Contact name
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Mr
R
Dalal
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Address
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Orthopaedics
Aspen House
Stepping Hill Hospital
Poplar Grove
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City/town
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Stockport
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Zip/Postcode
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SK2 7JE
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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 - 2007 Update - Department of Health
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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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Fax
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+44
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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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28/09/2007
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Last edited
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06/11/2007
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Date ISRCTN assigned
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28/09/2007
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