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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Asokumar Buvanendran, Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT00729690
First received: August 5, 2008
Last updated: November 20, 2012
Last verified: November 2012
  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
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Oral Pregabalin on Spinal Neurotransmitters in Patients Undergoing Total Knee Replacement (TKA)

Resource links provided by NLM:


Further study details as provided by Rush University Medical Center:

Primary Outcome Measures:
  • NRS Pain Score AUC (NRS*hr) - 1st 24 Hours [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Numerical Response scale NRS(0-10) Pain scores were collected every 4 hours after the initial dose and the Area Under the Curve (AUC) calculated. Calculated for the 1st 24 hours after initial dose (0-24hr). AUC measured in NRS pain score points per hour (NRS*hr). Larger AUC values indicate higher levels of reported pain.

  • NRS Pain Score AUC (NRS*hr) - 1st 12 Hours [ Time Frame: 12 hours Post dose ] [ Designated as safety issue: No ]
    Numerical Response scale NRS(0-10) Pain scores were collected every 4 hours after the initial dose and the Area Under the Curve (AUC) calculated. Calculated for the 1st 12 hours after initial dose (0-12hr). AUC measured in NRS pain score points per hour (NRS*hr). Larger AUC values indicate higher levels of reported pain.


Secondary Outcome Measures:
  • Active Knee Flexion [ Time Frame: PostOp day 2 ] [ Designated as safety issue: No ]
    The degree of active knee flexion (ROM) tolerated by the patient will be assessed at days 1 and 2 post-surgery. Active flexion is the unassisted moment of the joint by the subject. On postoperative (PostOp) day 2

  • Passive Knee Flexion [ Time Frame: PostOp day 2 ] [ Designated as safety issue: No ]
    Passive flexion is the moment of the joint with the assistance of a clinician (The clinician or therapist physically hold and moves the knee through it's range of motion).


Enrollment: 48
Study Start Date: August 2008
Study Completion Date: July 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Multi-Dose 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.
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.

Other Name: Lyrica
Experimental: 2 single-dose 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: 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.
Other Name: Lyrica
Placebo Comparator: 3 Placebo
Group 3 (n=16, placebo): patients receive matching placebo at the same 3 time points as Groups 1 and 2.
Drug: Placebo
Group 3 (n=16, placebo): patients receive matching placebo at the same 3 time points as Groups 1 and 2.
Other Name: Lyrica

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Asokumar Buvanendran
Pfizer
Investigators
Principal Investigator: Asokumar Buvanendran, MD Rush University Medical Center
Principal Investigator: Jeffery S Kroin, PhD Rush University Medical Center
  More Information

Publications:
Responsible Party: Asokumar Buvanendran, Attending Physician, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT00729690     History of Changes
Other Study ID Numbers: 08021105
Study First Received: August 5, 2008
Results First Received: October 18, 2012
Last Updated: November 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Rush University Medical Center:
Pregabalin
CSF
Neurotransmitter

Additional relevant MeSH terms:
Pregabalin
Gamma-Aminobutyric Acid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
GABA Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on October 19, 2014