Effect of Oral Pregabalin on Spinal Neurotransmitters in Patients Undergoing Knee Replacement - Full Text View

Purpose

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.

Condition	Intervention	Phase
Pain	Drug: Pregabalin	Phase III

MedlinePlus related topics:

Knee Replacement

ChemIDplus related topics:

Pregabalin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Bio-equivalence Study

Official Title:	Effects of Oral Pregabalin on Spinal Neurotransmitters in Patients Undergoing Total Knee Replacement (TKA)

Further study details as provided by Rush University Medical Center:

Primary Outcome Measures:

VAS pain scores will be obtained beginning at 4 h after the initial dose, and total intrathecal medication consumption will be recorded at each 8 h interval over a 32-hour period. [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Physical therapy will be initiated twice daily starting on the first postoperative day. The degree of active and passive knee flexion (ROM) tolerated by the patient will be assessed at days 1 and 2 post-surgery. [ Time Frame: 1week ] [ Designated as safety issue: No ]

Estimated Enrollment:	48
Study Start Date:	August 2008
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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.	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.
2: Active Comparator 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: Pregabalin Group 3 (n=16, placebo): patients receive matching placebo at the same 3 time points as Groups 1 and 2.
3: Placebo Comparator Group 3 (n=16, placebo): patients receive matching placebo at the same 3 time points as Groups 1 and 2.	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 3 (n=16, placebo): patients receive matching placebo at the same 3 time points as Groups 1 and 2.

Show Detailed Description

Eligibility

Ages Eligible for Study:	55 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

History of osteoarthritis
Subjects who can understand and communicate in English

Exclusion Criteria:

Younger than 55 years or older than 75 years.
American Society of Anesthesiologists physical status IV
Prior use of pregabalin or gabapentin will not be an exclusionary criterion; however patients will have been withdrawn from these medications at least 14 days before surgery
Patients who are currently enrolled in another investigational study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00729690

Contacts


Contact: Asokumar Buvanendran, MD	312-942 3685	asokumar_buvanendran@rush.edu

Contact: Sheetal Patel N Patel, MD	312-942 3421	sheetal_N_Patel@rush.edu

Locations


United States, Illinois
	Rush University Medical Center	Not yet recruiting
	Chicago, Illinois, United States, 60612
	Contact: Sheetal N Patel, MD
	Rush University Medical Center	Not yet recruiting
	Chicago, Illinois, United States, 60612
	Contact: Sheetal N Patel, MD 312-942-3421 Sheetal_N_Patel@rush.edu
	Contact: Ananda Ranga, MD 312-942 2741 rcananda@gmail.com
	Rush University Medical Center	Not yet recruiting
	Chicago, Illinois, United States, 60612
	Contact: Asokumar Buvanendran, M.D. 312-942-3685 asokumar@aol.com

Sponsors and Collaborators

Rush University Medical Center

Investigators


Principal Investigator:	Asokumar Buvanendran, MD	Rush University Medical Center

Principal Investigator:	Jeffery S Kroin, PhD	Rush University Medical Center

More Information

Responsible Party:	Department of Anesthesiology, Rush University Medical Center ( Asokumar Buvanendran, MD )
Study ID Numbers:	08021105
First Received:	August 5, 2008
Last Updated:	August 6, 2008
ClinicalTrials.gov Identifier:	NCT00729690
Health Authority:	United States: Institutional Review Board

Keywords provided by Rush University Medical Center:

Pregabalin

CSF

Neurotransmitter

Study placed in the following topic categories:

Pregabalin

Pain

Additional relevant MeSH terms:

Sensory System Agents

Therapeutic Uses

Physiological Effects of Drugs

Peripheral Nervous System Agents

Analgesics

Central Nervous System Agents

Anticonvulsants

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2008

Sponsored by:	Rush University Medical Center
Information provided by:	Rush University Medical Center
ClinicalTrials.gov Identifier:	NCT00729690