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
| ISRCTN | ISRCTN34631378 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34631378 |
| Secondary identifying numbers | N/A |
- Submission date
- 03/10/2005
- Registration date
- 25/10/2005
- Last edited
- 13/06/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Joseph Kay
Scientific
Scientific
Department of Anesthesia M3-200
Sunnybrook Health Sciences Centre
2075 Bayview Ave.
Toronto
M4N 3M5
Canada
| Phone | +1 416 480 4798 |
|---|---|
| joseph.kay@utoronto.ca |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study objectives | 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(s) | Ethics approval was received from the local medical ethics committee before trial recruitment began |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Gabapentin |
| Primary outcome measure | 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 study start date | 02/01/2007 |
| Completion date | 08/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 184 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 02/01/2007 |
| Date of final enrolment | 08/01/2008 |
Locations
Countries of recruitment
- Canada
Study participating centre
Department of Anesthesia M3-200
Toronto
M4N 3M5
Canada
M4N 3M5
Canada
Sponsor information
Sunnybrook Health Sciences Centre (Canada)
Hospital/treatment centre
Hospital/treatment centre
Department of Anesthesia M3-200
2075 Bayview Ave.
Toronto
M4N 3M5
Canada
| Website | http://mysw.sw.ca/ccm/bins/home.cfm |
|---|---|
"ROR" |
https://ror.org/03wefcv03 |
Funders
Funder type
Not defined
Not provided at time of registration
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
