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ISRCTN
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ISRCTN64506738
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ClinicalTrials.gov identifier
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Public title
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Effects of NMDA-receptor antagonism on hyperalgesia, opioid use, and pain after major surgery in young and elderly patients
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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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MCT-52682
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Study hypothesis
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Our primary aim is to determine whether perioperative NMDA-receptor antagonism has differential effects on postoperative pain, hyperalgesia and morbidity in younger and older patients. In order to achieve this aim, we propose to conduct the first randomized, double-blind placebo-controlled study designed to investigate age differences in the effects of perioperative oral administration of an NMDA-receptor antagonist (amantadine) in men undergoing radical prostatectomy. In addition, age differences in psychosocial factors and the pharmacological properties of amantadine and morphine will be measured to control for, and clarify, their contribution to the differences found.
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Lay summary
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Ethics approval
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Ethics approval received from the University Health Network Research Ethics Board, Toronto, Ontario on the 12th November 2003.
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Study design
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Randomised controlled trial
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Countries of recruitment
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Canada
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Disease/condition/study domain
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Postoperative pain in radical prostatectomy
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Participants - inclusion criteria
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1. Able to read and write English
2. Age 18 - 54 years or greater than 55 years, male
3. American Society of Anesthesiologists (ASA) class 1 to 3
4. Scheduled for elective radical prostatectomy
5. Body weight between 60 and 90 kg, Body Mass Index (BMI) less than or equal to 30
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Participants - exclusion criteria
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1. Significant Central Nervous System (CNS), respiratory, cardiac, hepatic, renal or endocrine dysfunction and/or any significant sequelae
2. Contraindications allergies to, and/or past adverse reactions to opioid analgesics or amantadine
3. History of Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) axis I disorder or cognitive dysfunction
4. History of epilepsy or other seizures
5. History of chronic pain of at least 6 months duration
6. History of long-term opioid use for chronic pain
7. History of long-term use of amantadine or other antiparkinsonian drug
8. Ingestion of antiussive medication within 48 hours before surgery
9. History of alcohol or drug dependency/abuse of at least 6 months duration
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Anticipated start date
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01/04/2002
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Anticipated end date
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31/12/2006
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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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132
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Interventions
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Amantadine versus Placebo comparison.
Trial details received: 12 September 2005
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Primary outcome measure(s)
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Hyperalgesia and opioid consumption.
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Secondary outcome measure(s)
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Assess age differences in the intensity and course of secondary hyperalgesia after surgery.
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Sources of funding
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Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-52682)
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Trial website
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Publications
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Contact name
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Dr
Lucia
Gagliese
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Address
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Department of Anaesthesia
Toronto General Hospital
200 Elizabeth Street
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City/town
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Toronto
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Zip/Postcode
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M5G 2C4
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Country
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Canada
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Tel
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+1 416 340 4296
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Fax
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+1 416 340 4739
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Email
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lucia.gagliese@uhn.on.ca
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Sponsor
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University Health Network, Toronto (Canada)
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Address
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200 Elizabeth Street
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City/town
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Toronto
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Zip/Postcode
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M5G 2C4
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Country
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Canada
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Email
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kfibiger@uhnres.utoronto.ca
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Sponsor website:
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http://www.uhnresearch.ca
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Date applied
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26/09/2005
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Last edited
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11/12/2007
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Date ISRCTN assigned
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26/09/2005
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