Contact information
Type
Scientific
Primary contact
Dr Joseph Kay
ORCID ID
Contact details
Department of Anesthesia M3-200
Sunnybrook Health Sciences Centre
2075 Bayview Ave.
Toronto
M4N 3M5
Canada
+1 416 480 4798
joseph.kay@utoronto.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Perioperative gabapentin is effective in improving in-patient rehabilitation in the acute postoperative period at 6 weeks and possibly 3 months after Total Knee Arthroplasty (TKA) and reduces pain scores associated with rehabilitation.
Ethics approval
Ethics approval was received from the local medical ethics committee before trial recruitment began
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Rehabilitation medicine and perioperative pain control
Intervention
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 8 hours after their Pre-Operative Dose (POD).
Intervention type
Drug
Phase
Not Applicable
Drug names
Gabapentin
Primary outcome measures
1. Does perioperative gabapentin administration positively influence early rehabilitation and recovery of physical function? If so, are these effects maintained at 6 weeks and 3 months post surgery?
2. Does perioperative gabapentin administration reduce postoperative movement evoked pain associated with rehabilitation? If so, are these effects also maintained at 6 weeks and 3 months post surgery?
Secondary outcome measures
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 4, 6 weeks and 3 months
6. Health-related Quality of Life Scores from the Western Ontario McMaster Universities Osteoarthritis (WOMAC) index
Overall trial start date
02/01/2007
Overall trial end date
08/01/2008
Reason abandoned
Eligibility
Participant inclusion criteria
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 1875 years of age.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
184
Participant exclusion criteria
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
Recruitment start date
02/01/2007
Recruitment end date
08/01/2008
Locations
Countries of recruitment
Canada
Trial participating centre
Department of Anesthesia M3-200
Toronto
M4N 3M5
Canada
Sponsor information
Organisation
Sunnybrook Health Sciences Centre (Canada)
Sponsor details
Department of Anesthesia M3-200
2075 Bayview Ave.
Toronto
M4N 3M5
Canada
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Not defined
Funder name
Not provided at time of registration
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary