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

Completed

Conditions: Signs and Symptoms
Rehabilitation medicine and perioperative pain control

Registration Number: ISRCTN34631378

Lead Sponsor: Sunnybrook Health Sciences Centre (Canada)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 184

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 18?75 years of age.

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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?<br>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

Name	Time	Method
1. A comparison of the means of morphine consumption between the two groups will be an outcome measures<br>2. Numeric Rating Scale (NRS) for pain will be used (0 = no pain, 10 = worst possible pain). Data will be collected as described previously<br>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<br>4. Sedation, as per the scale described above, at the same time intervals<br>5. A comparison of the Hospital Anxiety and Depression Scale (HADS) from baseline, POD 4, 6 weeks and 3 months<br>6. Health-related Quality of Life Scores from the Western Ontario McMaster Universities Osteoarthritis (WOMAC) index