Study to Investigate the Effectiveness of Pregabalin for Management of Patients Undergoing Total Hip Replacement
- Conditions
- Health Condition 1: null- Pain, Perioperative
- Registration Number
- CTRI/2009/091/000645
- Lead Sponsor
- Pfizer Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 256
1. Ages Eligible for Study: 18 Years and older
2. Genders Eligible for Study: Both
3. Accepts Healthy Volunteers: No
4. The patient is undergoing routine (i.e., expected to be uncomplicated) total primary or secondary hip replacement surgery performed under a standardized regimen of spinal anesthesia, and is expected to experience moderate to severe post-surgical pain in the absence of post-operative analgesia
-The patient is undergoing a revision to a previous hip replacement procedure
-The patient is undergoing an emergency hip replacement procedure, a hip replacement procedure further to a trauma, or a procedure expected to last longer than 4 hours
-The patient has a history of uncontrolled chronic disease or a concurrent clinically significant illness or medical condition, which in the Investigator's opinion, would contraindicate study participation or confound interpretation of the results
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean of the Pain on Movement scores obtained over Post-Op Days 1-5. The Pain on Movement assessments are performed using an 11-point Numeric Rating Scale [NRS] following passive flexion & adduction at hip joint at 12-hr interval intervalsTimepoint: 5 days
- Secondary Outcome Measures
Name Time Method Incidence of neuropathic pain as detected using the ID Pain questionnaire 3 & 6 months following the surgeryTimepoint: 6 Months;Mean of the Anxiety Visual Analog Scale (A-VAS) scores obtained from the assessment performed on the day of surgery through to Post-Op Day 5Timepoint: 5 Days;Mean of the Daily Pain Scores (11-point NRS) obtained on Post-Op Days 1-7, and mean of the Daily Pain Scores obtained on Post-Op Days 8-14Timepoint: 14 days;Mean of the Daily Sleep Interference Scores (11-point NRS) obtained on Post-Op Days 1-5Timepoint: 5 days;Safety & tolerability of pregabalin versus placebo in patients undergoing primary total hip arthroplastyTimepoint: 14 days;Time to mobilization (day on which patient is able to walk 5 steps for the first time post-surgery)Timepoint: 5 days;Use of rescue analgesics administered on Post-Op Days 0 - 5Timepoint: 5days