Overview

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

Status:
Terminated
Trial end date:
2012-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pfizer
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Treatments:
Pregabalin
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