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ISRCTN
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ISRCTN48374927
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DOI
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10.1186/ISRCTN48374927
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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The role of glutamate in the development of phantom limb pain
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Scientific title
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A randomised double blind trial of the effect of pre-emptive epidural ketamine on persistent pain after lower limb amputation
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Acronym
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N/A
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Serial number at source
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SP3481
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Study hypothesis
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To assess the effect of pre-emptively modulating sensory input with epidural ketamine (an NMDA antagonist) on post-amputation pain and sensory processing.
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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 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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Pain
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Participants - inclusion criteria
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1. Patients undergoing lower limb amputation for peripheral vascular disease or as a result of complications of diabetes mellitus
2. Able to give informed consent and cooperate with pain assessment
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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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01/01/2001
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Anticipated end date
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01/01/2007
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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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53
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Interventions
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All patients will have spinal and epidural anaesthesia with bupivacaine established before amputation and will receive an epidural infusion of bupivacaine for 48 to 72 hours after surgery for post-operative analgesia.
Patients will be randomised to receive either:
1. An epidural bolus of ketamine before surgery followed by epidural ketamine infusion for 48 to 72 hours
2. A placebo
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Primary outcome measure(s)
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Incidence and severity of post-amputation pain measured at one year.
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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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Action Medical Research (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/17583431
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Contact name
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Dr
Alastair F
Nimmo
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Address
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University of Edinburgh Department of Anaesthesia Critical Care and Pain Medicine
Royal Infirmary of Edinburgh
Lauriston Place
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City/town
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Edinburgh
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Zip/Postcode
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EH3 9YW
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Country
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United Kingdom
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Tel
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+44 (0)131 536 3652
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Fax
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+44 (0)131 536 3672
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Email
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a.nimmo@ed.ac.uk
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Sponsor
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Action Medical Research (UK)
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Address
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Vincent House
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City/town
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Horsham West Sussex
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Zip/Postcode
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RH12 2DP
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Country
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United Kingdom
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Sponsor website:
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http://www.action.org.uk/
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Date applied
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01/03/2001
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Last edited
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14/01/2009
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Date ISRCTN assigned
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01/03/2001
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