MedTrace Logo

Effect of Oral Pregabalin on Spinal Neurotransmitters in Patients Undergoing Knee Replacement

NCT00729690 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2012-12-19

Study results available
· View outcomes & findings →

Summary

This study involves research. Pregabalin is a Food and Drug Administration (FDA) medication approved in the United States for the treatment of nerve pain related to diabetes and post-herpetic neuralgia "shingles", and for seizures in adults. The purpose of this research is to study the effect of oral Pregabalin on spinal neurotransmitters in subjects undergoing Total Knee Replacement Surgery (TKA). TKA is associated with considerable postoperative pain which if unrelieved may result in prolonged hospital stay, inability to participate in rehabilitation programs, poor outcomes, and greater use of health-care resources. This study examines the effect of pregabalin administered for TKA on pain-related neurotransmitter concentrations.

Conditions

Interventions

DRUG

Pregabalin

Group 1 (n=16, multi-dose pregabalin): patients receive pregabalin 150 mg orally 1 hour prior to surgery and then repeat 150 mg doses at 12 and 24 hours after initial dose. Group 2 (n=16, single dose pregabalin): patients receive pregabalin 150 mg orally 1 hour prior to surgery, and then placebo doses at 12 and 24 hours after initial dose. Group 3 (n=16, placebo): patients receive matching placebo at the same 3 time points as Groups 1 and 2.

DRUG

Pregabalin

Group 2 (n=16, single dose pregabalin): patients receive pregabalin 150 mg orally 1 hour prior to surgery, and then placebo doses at 12 and 24 hours after initial dose.

DRUG

Placebo

Group 3 (n=16, placebo): patients receive matching placebo at the same 3 time points as Groups 1 and 2.

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Asokumar Buvanendran

    lead OTHER

Principal Investigators

  • Asokumar Buvanendran, MD · Rush University Medical Center

  • Jeffery S Kroin, PhD · Rush University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2011-06-30
Completion
2011-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00729690 on ClinicalTrials.gov