Clinical trial NCT00905437: Study To Investigate The Effectiveness Of Pregabalin For Management Of Patients Undergoing Total Hip Replacement
Official title: Randomized Double-Blind, Multi-Center Study Of Efficacy And Tolerability Of Pregabalin Versus Placebo As An Adjunct To Standard Of Care For Perioperative Management Of Patients Undergoing Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Pain, Perioperative
Keywords: perioperative
pregabalin
total hip replacement
post-operative pain
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-05-20
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is the investigate if pregabalin started a day before surgery and continued for 14 days post-operatively can reduce post-operative pain, relieve pre- and post-operative anxiety and sleep disturbances.


Eligibility criteria: Inclusion Criteria:

* The patient is undergoing a 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

Exclusion Criteria:

* The patient is undergoing a revision to a previous hip replacement procedure, hip replacement procedure further to a road traffic accident with multiple injuries, 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

Primary outcomes:
measure: Mean Pain on Movement Score
timeFrame: Every 12 hours from Day 1 to Day 5 post-surgery
Secondary outcomes:
measure: Mean Daily Pain Score
timeFrame: Day 1 to Day 7, Day 8 to Day 14 post-surgery
measure: Mean Daily Sleep Interference Score
timeFrame: Day 1 to Day 5 post-surgery
measure: Mean Anxiety Visual Analogue Scale (A-VAS)
timeFrame: Day 0 to Day 5 post-surgery
measure: Time to Mobilization After Surgery
timeFrame: Day 1 to Day 5 post-surgery
measure: Number of Participants With Rescue Medication Usage
timeFrame: Day 0 to Day 6 post-surgery
measure: Number of Participants With Neuropathic Pain
timeFrame: Day 90, Day 180 post-surgery
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Pfizer Investigational Site
state: Andhra Pradesh
city: Ahmedabad
country: India
facility: Pfizer Investigational Site
state: Gujarat
city: Bangalore
country: India
facility: Pfizer Investigational Site
state: Karnataka
city: Kanpur
country: India
facility: Pfizer Investigational Site
state: Uttar Pradesh,
city: Kanpur
country: India
facility: Pfizer Investigational Site
state: Uttar Pradesh
city: Kolkata
country: India
facility: Pfizer Investigational Site
state: West Bengal
city: New Delhi
country: India
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: