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Clinical Trial Details

NCT ID: NCT00762099
Date Last Changed: April 7, 2011

Overview

Research Study Summary

A clinical trial to evaluate treatments using Pregabalin and Placebo for patients with Anxiety

Research Study Title

The Short and Long Term Effects of Perioperative Pregabalin Use on Functional Rehabilitation, Pain Outcomes and Anxiety Following Total Hip Arthroplasty: A Randomized, Double-Blind, Placebo-Controlled Trial.

Purpose

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.

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Recruitment Details

Phase
4
Gender
Both Male and Female
Age
18 to 75 Years
Overall Status
Recruiting
Lead Sponsor
Sunnybrook Health Sciences Centre
Duration
31 Months
Facility Type
N/A
Compensation

Eligibility

Both Male and Female ages 18 Years to 75 Years

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).

Site Locations (1)

Country State City Zip Facility and Contact
Canada Ontario Toronto M4Y 1H1 Holland Orthopaedic and Arthritic Centre
Hance Clarke, MD
416-340-4800 ext. 6649
hance.clarke@utoronto.ca

Colin McCartney, MD
Principal Investigator

Contact

Colin McCartney, MD
416 480 6100 ext. 1709
E-mail:

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