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

Viatris

Status and phase: Terminated; Phase 3

Conditions: Pain, Perioperative

Treatments: Drug: Placebo; Drug: Pregabalin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00905437

A0081229

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo as an adjunct to standard of care

Treatment:

Drug: Placebo

Pregabalin

Active Comparator group

Description:

Pregabalin as an adjunct to standard of care

Treatment:

Drug: Pregabalin