Study To Investigate The Effectiveness Of Pregabalin For Management Of Patients Undergoing Total Hip Replacement

Phase 3TerminatedNCT00905437

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.72 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

Conditions

Pain, Perioperative

Interventions

PlaceboDRUG

Placebo as an adjunct to standard of care

PregabalinDRUG

75 mg BD for 14 days

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (7)

Pfizer Investigational Site

Hyderabad, Andhra Pradesh, India

Pfizer Investigational Site

Ahmedabad, Gujarat, India

Pfizer Investigational Site

Bangalore, Karnataka, India

Pfizer Investigational Site

Kanpur, Uttar Pradesh, India

Outcomes

Primary Outcomes

Mean Pain on Movement Score

Mean pain on movement score was defined as the mean of the pain on movement score over Days 1 to 5 post-surgery. Pain experienced by participant during passive flexion through 90 degree and passive abduction through 30 degree at operated hip joint was evaluated on a scale of 0 to 10 where, 0= no pain and 10= worst possible pain.

Time frame: Every 12 hours from Day 1 to Day 5 post-surgery

Secondary Outcomes

Mean Daily Pain Score

Mean daily pain score was defined as the mean of daily pain score over Days 1 to 7 and Days 8 to 14 post-surgery. Daily Pain Rating Scale (DPRS): participant rated 11-point Likert scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain.

Time frame: Day 1 to Day 7, Day 8 to Day 14 post-surgery

Mean Daily Sleep Interference Score

Mean daily sleep interference score was defined as the mean of daily sleep interference numeric rating scale (NRS) score over Days 1 to 5 post-surgery. Daily Sleep Interference Scale (DSIS): participant rated pain during past 24-hour period on NRS ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep). Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication.

Time frame: Day 1 to Day 5 post-surgery

Mean Anxiety Visual Analogue Scale (A-VAS)

Mean anxiety visual analogue scale (VAS) was defined as the mean of VAS score on the day of surgery and over Days 1 to 5 post-surgery. Participants measured their degree of anxiety over past 24 hours on a VAS of 0 to 100, where 0 = not at all anxious to 100 = extremely anxious.

Time frame: Day 0 to Day 5 post-surgery

Time to Mobilization After Surgery

Data from ClinicalTrials.gov

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