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
Protocol serial number	N/A
Sponsor	Sunnybrook Health Sciences Centre (Canada)
Funder	Not provided at time of registration

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

Department of Anesthesia M3-200
Sunnybrook Health Sciences Centre
2075 Bayview Ave.
Toronto
M4N 3M5
Canada

Phone	+1 416 480 4798
Email	joseph.kay@utoronto.ca

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Gabapentin
Primary outcome measure(s)	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?
Key secondary outcome measure(s)	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
Completion date	08/01/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes