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

This study has been terminated.
(The Study was terminated on May 24th 2012 due to a slow recruitment rate. The study was not terminated for reasons of safety or efficacy.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00905437
First received: May 19, 2009
Last updated: April 25, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Pain, Perioperative
Drug: Placebo
Drug: Pregabalin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Mean Pain on Movement Score [ Time Frame: Every 12 hours from Day 1 to Day 5 post-surgery ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Mean Daily Pain Score [ Time Frame: Day 1 to Day 7, Day 8 to Day 14 post-surgery ] [ Designated as safety issue: No ]
    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.

  • Mean Daily Sleep Interference Score [ Time Frame: Day 1 to Day 5 post-surgery ] [ Designated as safety issue: No ]
    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.

  • Mean Anxiety Visual Analogue Scale (A-VAS) [ Time Frame: Day 0 to Day 5 post-surgery ] [ Designated as safety issue: No ]
    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 to Mobilization After Surgery [ Time Frame: Day 1 to Day 5 post-surgery ] [ Designated as safety issue: No ]
    Participant was encouraged each day (from Day 3) to attempt walking depending upon the degree of pain on standing. The first day on which the participant was able to walk for 5 steps was the day of mobilization. Median time to mobilization (in hours) was calculated till the day of mobilization.

  • Number of Participants With Rescue Medication Usage [ Time Frame: Day 0 to Day 6 post-surgery ] [ Designated as safety issue: No ]
    Rescue medications were used for participants with moderate or severe resting pain. Fentanyl injection (25 microgram [mcg] intravenous bolus to a maximum dose of 3 milliliter/day), paracetamol tablet (15 milligram/kilogram orally to a maximum dose of 45 milligram/kilogram/day) were used as rescue medications.

  • Number of Participants With Neuropathic Pain [ Time Frame: Day 90, Day 180 post-surgery ] [ Designated as safety issue: No ]
    ID Pain questionnaire was used to assess neuropathic pain. 6 items questionnaire, did pain feel like: (1)pins and needles (2)hot/burning (3)numb (4)electrical shocks (5)is pain made worse with touch of clothing or bed sheets (6)is pain limited to your joints. "Yes" response to questions 1-5 were scored as 1, while a "yes" response to question 6 was scored as -1. "No" response were scored as 0. Overall score range -1 to 5.Higher score more indicative of pain with a neuropathic component. Number of participants with score 2 or more (which indicated nerve pain) were reported.


Enrollment: 72
Study Start Date: November 2009
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo as an adjunct to standard of care
Drug: Placebo
Placebo as an adjunct to standard of care
Active Comparator: Pregabalin
Pregabalin as an adjunct to standard of care
Drug: Pregabalin
75 mg BD for 14 days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00905437

Locations
India
Pfizer Investigational Site
Hyderabad, Andhra Pradesh, India, 500 033
Pfizer Investigational Site
Ahmedabad, Gujarat, India, 380 015
Pfizer Investigational Site
Bangalore, Karnataka, India, 560 076
Pfizer Investigational Site
Kanpur, Uttar Pradesh,, India, 208 001
Pfizer Investigational Site
Kanpur, Uttar Pradesh, India, 208 002
Pfizer Investigational Site
Kolkata, West Bengal, India, 700 054
Pfizer Investigational Site
New Delhi, India, 110 017
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00905437     History of Changes
Other Study ID Numbers: A0081229
Study First Received: May 19, 2009
Results First Received: April 25, 2013
Last Updated: April 25, 2013
Health Authority: India: Drugs Controller General of India

Keywords provided by Pfizer:
perioperative
pregabalin
total hip replacement
post-operative pain

Additional relevant MeSH terms:
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 31, 2014