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Effect of Oral Pregabalin on Spinal Neurotransmitters in Patients Undergoing Knee Replacement
This study is currently recruiting participants.
Verified by Rush University Medical Center, October 2008
Sponsored by: Rush University Medical Center
Information provided by: Rush University Medical Center
ClinicalTrials.gov Identifier: NCT00729690
  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
Drug Information available for: 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 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 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
Study First Received: August 5, 2008
Last Updated: October 2, 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 January 13, 2009