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ISRCTN
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ISRCTN68691928
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ClinicalTrials.gov identifier
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Public title
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Prospective, double-blind, randomised trial to assess the efficacy of continuous sciatic/posterior tibial nerve blockade via a neural sheath catheter in lower limb amputees
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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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56481676
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Study hypothesis
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That continuous neural sheath infusion of levobupivacaine after major lower limb amputation will reduce the incidence of late phantom pain/phantom limb sensations and stump pain.
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Ethics approval
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Ethics approval received from the Trent Research Ethics Committee on the 13th August 2007 (ref: 07/H0405/42).
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Study design
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Randomised placebo controlled double blind study
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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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Lower limb amputation
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Participants - inclusion criteria
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Patients admitted to our vascular unit requiring a below or above knee amputation irrespective of aetiology.
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Participants - exclusion criteria
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1. Patients not considered for surgical intervention
2. Patients who are deemed unfit to undergo surgery under general anaesthesia
3. Patients unable to operate a Patient-Controlled Analgesia (PCA) device or cooperate with evaluation of pain scores e.g. those with confusional states
4. Patients unwilling to consent
5. Allergy to any study medication
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Anticipated start date
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01/07/2007
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Anticipated end date
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01/01/2010
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Status of trial
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Ongoing
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Patient information material
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Target number of participants
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62
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Interventions
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Perineural infusion of levobupivacaine 1.25 mg/ml versus placebo for 96 hours after surgery.
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Primary outcome measure(s)
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Late stump pain, phantom limb sensations and phantom limb pain up to one year after surgery.
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Secondary outcome measure(s)
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1. Early postoperative pain and morphine requirements
2. Late effects on mood, physical disability and quality of life, measured using the Late Life disability index (quality of life and disability), the 36-item Short Form health survey (SF-36) inventory, (pain and disability) the McGill pain questionnaire (pain) and the University of Leicester Amputee questionnaire (pain and disability)
Secondary outcomes will be measured at 6 weeks, 3, 6 and 12 months after surgery.
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Sources of funding
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Association of Anaesthetists of Great Britain and Ireland (UK)
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Trial website
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Publications
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Contact name
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Dr
Jonathan
Thompson
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Address
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University Hospitals of Leicester NHS Trust
Department of Anaesthesia Critical Care and Pain Management
Victoria Building
Leicester Royal Infirmary
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City/town
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Leicester
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Zip/Postcode
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LE1 5WW
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Country
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United Kingdom
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Tel
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+44 (0)116 258 5291
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Email
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jt23@le.ac.uk
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Sponsor
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University Hospitals of Leicester NHS Trust (UK)
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Address
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c/o Professor David Rowbotham
Research Office
Leicester General Hospital
Gwendolen Road
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City/town
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Leicester
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Zip/Postcode
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LE5 4PW
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Country
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United Kingdom
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Tel
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+44 (0)116 258 4199
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Fax
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+44 (0)116 258 4226
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Email
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djr8@le.ac.uk
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Sponsor website:
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http://www.uhl-tr.nhs.uk/
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Date applied
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29/05/2007
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Last edited
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21/09/2007
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Date ISRCTN assigned
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16/07/2007
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