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ISRCTN
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ISRCTN14907042
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ClinicalTrials.gov identifier
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Public title
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Evaluation of gabapentin as a preemptive analgesic for patients undergoing total hip arthroplasty
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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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N/A
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Study hypothesis
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1. Gabapentin administration reduces pain and opioid use postoperatively after total hip arthroplasty
2. Preoperative gabapentin is more effective than postoperative administration. This will definitively demonstrate the preemptive analgesic properties of gabapentin.
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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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Canada
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Disease/condition/study domain
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Preemptive Pain Medication/Postoperative Pain Control
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Participants - inclusion criteria
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Upon obtaining informed consent, patients with American Society of Anesthesiologists physical status I and II, of both genders, scheduled for hip arthroplasty will be recruited for this double blinded, prospective, randomized, and placebo controlled study. Patients must also be 18–70 years of age.
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Participants - exclusion criteria
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Patients will not be enrolled in this study for the following reasons:
1. Patients not providing informed consent
2. Patients less than 18 years of age and greater than 75 years of age
3. Known allergy to any of the medications being used
4. History of drug or alcohol abuse
5. Patients with chronic pain on slow-release preparations of opioid
6. Patients with Rheumatoid Arthritis
7. Patients with psychiatric disorders
8. Patients unable or unwilling to use Patient Controlled Analgesia
9. Diabetic patients or those with impaired renal function (Creatinine >106)
10. Obese patients (i.e. body mass index [BMI] >40)
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Anticipated start date
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01/01/2006
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Anticipated end date
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01/12/2006
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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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90
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Interventions
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This is a prospective, randomized, double blind, placebo-controlled study to compare total morphine consumption between the preemptive gabapentin, the postoperative gabapentin and the placebo groups. Patients will be randomly assigned to one of three treatment arms with 30 patients in each arm. Patients who are randomized to the preoperative gabapentin group will receive 600 mg orally (po) prior to surgery. The other two treatment arms will receive either placebo or gabapentin 600 mg 1 hour after their surgery is complete.
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Primary outcome measure(s)
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A comparison of the means of morphine consumption among the various treatment groups will be the primary outcome measure.
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Secondary outcome measure(s)
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1. Visual Analog Scale (VAS) for pain will be used (0 = no pain, 100 = terrible pain)
2. Presence of nausea, vomiting, pruritis, and dizziness will be monitored at the same time intervals, and all except the latter, treated as per the Acute Pain Service Nausea and Vomiting algorithm
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Sources of funding
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Not yet finalised
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Trial website
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Publications
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2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19572933
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Contact name
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Dr
Joseph
Kay
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Address
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Department of Anesthesia M3-200
Sunnybrook Health Sciences Centre
2075 Bayview Ave.
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City/town
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Toronto
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Zip/Postcode
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M4N 3M5
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Country
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Canada
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Tel
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+1 416 480 4798
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Fax
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+1 416 480 6039
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Email
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joseph.kay@utoronto.ca
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Sponsor
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Sunnybrook Health Sciences Centre (Canada)
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Address
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Department of Anesthesia M3-200
2075 Bayview Ave.
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City/town
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Toronto
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Zip/Postcode
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M4N 3M5
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Country
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Canada
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Date applied
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07/10/2005
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Last edited
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11/09/2009
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Date ISRCTN assigned
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20/10/2005
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