Recruiting

Pregabalin

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT00762099

Conditions

Anxiety

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Pregabalin

Placebo

Study Details

Brief summary:

Pain prior to surgery is of particular concern in patients undergoing total hip arthroplasty (THA) since it is the most important predictor of pain and poor function 2-3 years after surgery. Previous studies have investigated various treatments for managing pain during and after surgery. However, no study has investigated the short and long term effects of pregabalin in terms of functional rehabilitation, pain outcome and anxiety following total hip arthroplasty. Therefore, the aim of the present study is determine if the following: (1) if perioperative pregabalin administration positively influence early rehabilitation and recovery of physical function and to determine if these effects maintained at 6 weeks and 3 months post surgery. (2) To determine if perioperative pregabalin administration reduce postoperative movement evoked pain associated with rehabilitation and if these effects also maintained at 6 weeks and 3 months post surgery.

Conditions

Anxiety

Study ID

NCT00762099

Start date

May, 2009

Status verified date

Apr, 2011

Completion date

Dec, 2011

Anticipated

Primary completion date

Dec, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Provision of informed consent, American Society of Anesthesiologists physical status I-III, VAS > 5, age18-75 years, male or female, scheduled for THA.

Exclusion Criteria:

Patients will not be enrolled in this study for the following reasons:

  • Patients not providing informed consent.
  • Known allergy to any of the medications being used.
  • History of drug or alcohol abuse.
  • Patients with chronic pain on slow-release preparations of opioid.
  • Patients with Rheumatoid Arthritis.
  • Patients with psychiatric disorders.
  • Patients unable or unwilling to use Patient Controlled Analgesia. (PCA)
  • Diabetic patients or those with impaired renal function (Creatinine >106).
  • Obese patients (i.e. BMI > 40).

Study Design

Enrollment

184 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 1

Pregabalin Group

placebo comparator: 2

Placebo group

Interventions

Pregabalin

Pre-operative dose 150 mg Post-operative dose 75 mg BID

Placebo

Placebo/sugar tabs will look identical to active drug.

Primary outcome measure

  • Physical function 6 weeks and 3-months post-total hip arthroplasty [ Time Frame: Up to 3 months ]

Central Contacts and Locations

Central contacts

Colin McCartney, MD

416 480 6100colin.mccartney@sunnybrook.ca

Locations

Holland Orthopaedic and Arthritic Centre

Recruiting

Toronto, Ontario, Canada, M4Y 1H1

Contacts

Hance Clarke, MD

416-340-4800hance.clarke@utoronto.ca

Principal Investigator:

Colin McCartney, MD

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Apr 8, 2011

Last verified

Apr, 2011

Keywords

  • Arthroplasty, Hip
  • Hip replacement
  • Pain Management
  • Functional Rehabilitation
  • Anxiety
  • Perioperative
  • Pregabalin
  • Arthroplasty

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2011-04-08.