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

NCT00729690 | Completed Phase 3 Results

• 1 other identifier: 08021105
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

PAIN

Keywords

Pregabalin; CSF; Neurotransmitter

Outcome Measures

Primary Outcomes (2)

• NRS Pain Score AUC (NRS*hr) - 1st 24 Hours

  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.

  24 hours

• NRS Pain Score AUC (NRS*hr) - 1st 12 Hours

  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.

  12 hours Post dose

Secondary Outcomes (2)

• Active Knee Flexion

  PostOp day 2

• Passive Knee Flexion

  PostOp day 2

Study Arms (3)

1 Multi-Dose Pregabalin

EXPERIMENTAL

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

2 single-dose pregabalin

EXPERIMENTAL

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

3 Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Pregabalin DRUG

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.

Also known as: Lyrica

1 Multi-Dose Pregabalin

Placebo DRUG

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

Also known as: Lyrica

3 Placebo

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of osteoarthritis
• Subjects who can understand and communicate in English

You may not qualify if:

• Younger than 55 years or older than 75 years.
• American Society of Anesthesiologists physical status IV
• Patients who are currently enrolled in another investigational study.

Sponsors & Collaborators

• Asokumar Buvanendran: lead
• Pfizer: collaborator

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

• Buvanendran A, Kroin JS, Della Valle CJ, Moric M, Tuman KJ. Cerebrospinal fluid neurotransmitter changes during the perioperative period in patients undergoing total knee replacement: a randomized trial. Anesth Analg. 2012 Feb;114(2):434-41. doi: 10.1213/ANE.0b013e31823dc5fb. Epub 2011 Dec 9.

  PMID: 22156332 RESULT

MeSH Terms

Conditions

Pain

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Asokumar Buvanendran
• Organization: Rush University

asokumar@aol.com

(312) 942-3685

Study Officials

• Asokumar Buvanendran, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

• Jeffery S Kroin, PhD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: August 5, 2008
• First Posted: August 7, 2008
• Study Start: August 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: July 1, 2011
• Last Updated: December 19, 2012
• Results First Posted: December 19, 2012

Record last verified: 2012-11

Locations

US (1)