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ISRCTN
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ISRCTN34631378
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ClinicalTrials.gov identifier
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Public title
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The short and long term effects of perioperative gabapentin use on functional, rehabilitation and pain outcomes following total knee arthroplasty: a randomised, double-blind, placebo-controlled trial
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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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Perioperative gabapentin is effective in improving in-patient rehabilitation in the acute postoperative period at six weeks and possibly three months after Total Knee Arthroplasty (TKA) and reduces pain scores associated with rehabilitation.
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Lay summary
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Ethics approval
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Ethics approval was received from the local medical ethics committee before trial recruitment began.
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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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Rehabilitation medicine and perioperative 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 total knee arthroplasty will be recruited for this double blinded, prospective, randomised, and placebo controlled study. Patients must also be 18–75 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 (PCA)
9. Diabetic patients or those with impaired renal function (Creatinine >106)
10. Obese patients (i.e. body mass index [BMI] >40)
11. Postoperatively, patients will be excluded if they have had additional operative procedures requiring a change in the usual rehabilitation protocol of care
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Anticipated start date
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02/01/2007
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Anticipated end date
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08/01/2008
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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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184
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Interventions
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Patients will either receive perioperative gabapentin (n = 92) for five perioperative days or placebo pills (n = 92) for the intervention period within a multimodal analgesic regimen.
Therefore, patients will be given either placebo or gabapentin 600 mg two hours prior to surgery and then either placebo or gabapentin 200 mg twice daily starting eight hours after their Pre-Operative Dose (POD).
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Primary outcome measure(s)
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1. Does perioperative gabapentin administration positively influence early rehabilitation and recovery of physical function? If so, are these effects maintained at six weeks and three months post surgery?
2. Does perioperative gabapentin administration reduce postoperative movement evoked pain associated with rehabilitation? If so are these effects also maintained at six weeks and three months post surgery?
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Secondary outcome measure(s)
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1. A comparison of the means of morphine consumption between the two groups will be an outcome measures
2. Numeric Rating Scale (NRS) for pain will be used (0 = no pain, 10 = worst possible pain). Data will be collected as described previously
3. Presence of nausea, vomiting, pruritus, 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
4. Sedation, as per the scale described above, at the same time intervals
5. A comparison of the Hospital Anxiety and Depression Scale (HADS) from baseline, POD four, six weeks and three months
6. Health related Quality of Life Scores from the Western Ontario McMaster Universities Osteoarthritis (WOMAC) index
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Sources of funding
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Have applied for funding
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Trial website
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Publications
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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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Sponsor website:
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http://mysw.sw.ca/ccm/bins/home.cfm
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Date applied
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03/10/2005
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Last edited
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17/09/2008
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Date ISRCTN assigned
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25/10/2005
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