Role of Pregabalin in Treatment of Post-Op Pain in Fracture Patients

Summary

This is a randomized, prospective, double-blind pilot study designed to evaluate the potential effectiveness of pregabalin in post-operative pain management for patients who have sustained a fracture.

Conditions

• Post-operative Pain

Interventions

DRUG

Placebo

Two hours before surgery, patients will receive 75mg of pregabalin. Patients will be placed on a patient-controlled anesthesia pump (PCA) for 24 hours. On post-operative day one, the patients will be switched to oral oxycodone as needed with supplementation with IV Demerol for breakthrough pain. In addition, patients will receive a placebo PO BID beginning on the day of surgery until discharge. Upon discharge, the patient will be given study medication (placebo PO BID). Rescue medications will be allowed during the study (including post-operative and outpatient periods). Outpatient rescue medications will consist of hydrocodone/APAP 7.5mg PO Q6H PRN. Patients will be followed for three months as an outpatient.

DRUG

Pregabalin

Two hours before surgery, patients will receive 75mg of pregabalin. Patients will be placed on a patient-controlled anesthesia pump (PCA) for 24 hours. On post-operative day one, the patients will be switched to oral oxycodone as needed with supplementation with IV Demerol for breakthrough pain. In addition, patients will receive 75mg PO BID beginning on the day of surgery until discharge. Upon discharge, the patient will be given study medication (pregabalin 75mg PO BID). Rescue medications will be allowed during the study (including post-operative and outpatient periods). Outpatient rescue medications will consist of hydrocodone/APAP 7.5mg PO Q6H PRN. Patients will be followed for three months as an outpatient.

DRUG

Pregabalin

Two hours before surgery, patients will receive 75mg of pregabalin. Patients will be placed on a patient-controlled anesthesia pump (PCA) for 24 hours. On post-operative day one, the patients will be switched to oral oxycodone as needed with supplementation with IV Demerol for breakthrough pain. In addition, patients will receive 150mg PO BID beginning on the day of surgery until discharge. Upon discharge, the patient will be given study medication (pregabalin 150mg PO BID). Rescue medications will be allowed during the study (including post-operative and outpatient periods). Outpatient rescue medications will consist of hydrocodone/APAP 7.5mg PO Q6H PRN. Patients will be followed for three months as an outpatient.

Sponsors & Collaborators

• Pfizer

  collaborator INDUSTRY

• University of Alabama at Birmingham

  lead OTHER

Principal Investigators

• Steven Theiss, MD · The University of Alabama at Birmingham

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

19 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-05-31

Primary Completion

2009-08-31

Completion

2009-08-31

Countries

• United States

Study Locations