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Role of Pregabalin in Treatment of Post-Op Pain in Fracture Patients (LYRICA)
This study is currently recruiting participants.
Verified by University of Alabama at Birmingham, February 2009
First Received: December 21, 2007   Last Updated: February 12, 2009   History of Changes
Sponsor: University of Alabama at Birmingham
Collaborator: Pfizer
Information provided by: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00583869
  Purpose

This is a randomized, prospective, double-blind pilot study designed to evaluate the potential effectiveness of pregabalin in post-operative pain management for patients who have sustained a fracture.


Condition Intervention Phase
Post-Operative Pain
Drug: Placebo
Drug: Pregabalin
Phase 0

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title: The Role of Pregabalin in the Treatment of Post-Operative Pain in Fracture Patients

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Amount of pain medication in morphine equivalent units used during the hospitalization. [ Time Frame: Screening - 5 - 15 minutes; Consent - 5-15 minutes; Follow-up - three 15-30-minute visits ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary outcome measures will include Visual Analog Score, timing and frequency of rescue medications, Short-Form 36 Health Survey scores, and adverse events. [ Time Frame: Three 15-30-minute visits after surgery to complete SF-36 and Visual Analog Score for Pain. ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: February 2009
Estimated Study Completion Date: February 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Placebo Comparator
Patient to receive placebo beginning on the day of surgery until discharge.
Drug: Placebo

Two hours before surgery, patients will receive 75mg of pregabalin. Patients will be placed on a patient-controlled anesthesia pump (PCA) for 24 hours. On post-operative day one, the patients will be switched to oral oxycodone as needed with supplementation with IV Demerol for breakthrough pain. In addition, patients will receive a placebo PO BID beginning on the day of surgery until discharge.

Upon discharge, the patient will be given study medication (placebo PO BID). Rescue medications will be allowed during the study (including post-operative and outpatient periods). Outpatient rescue medications will consist of hydrocodone/APAP 7.5mg PO Q6H PRN. Patients will be followed for three months as an outpatient.

2: Experimental
Patient to receive 75mg PO BID pregabalin beginning on the day of surgery until discharge.
Drug: Pregabalin

Two hours before surgery, patients will receive 75mg of pregabalin. Patients will be placed on a patient-controlled anesthesia pump (PCA) for 24 hours. On post-operative day one, the patients will be switched to oral oxycodone as needed with supplementation with IV Demerol for breakthrough pain. In addition, patients will receive 75mg PO BID beginning on the day of surgery until discharge.

Upon discharge, the patient will be given study medication (pregabalin 75mg PO BID). Rescue medications will be allowed during the study (including post-operative and outpatient periods). Outpatient rescue medications will consist of hydrocodone/APAP 7.5mg PO Q6H PRN. Patients will be followed for three months as an outpatient.

3: Experimental
Patient to receive 150mg PO BID pregabalin beginning on the day of surgery until discharge.
Drug: Pregabalin

Two hours before surgery, patients will receive 75mg of pregabalin. Patients will be placed on a patient-controlled anesthesia pump (PCA) for 24 hours. On post-operative day one, the patients will be switched to oral oxycodone as needed with supplementation with IV Demerol for breakthrough pain. In addition, patients will receive 150mg PO BID beginning on the day of surgery until discharge.

Upon discharge, the patient will be given study medication (pregabalin 150mg PO BID). Rescue medications will be allowed during the study (including post-operative and outpatient periods). Outpatient rescue medications will consist of hydrocodone/APAP 7.5mg PO Q6H PRN. Patients will be followed for three months as an outpatient.


Detailed Description:

On admission, all patients who have sustained orthopaedic injuries of any type, including pelvis, will be screened. However, only those patients who will undergo a single episode of surgery during this hospitalization to surgically repair only one of their orthopaedic fractures will be interviewed by a clinical research nurse. If the patient meets all criteria for inclusion/exclusion in the study, the attending physician will consent the patient for inclusion in the study. Upon enrollment into the study, the clinical research nurse will obtain a thorough history from the patient concerning prior narcotic use, response to painful events in the past and will record details of the injury. Prior to surgery, the patient will be treated with narcotic pain medication as required in the judgment of the attending physician. The patient will then be randomized before surgery into a placebo group or pregabalin group. The attending physician will be blinded as to which study arm the patient is in.

Two hours before surgery, patients will receive 75mg of pregabalin. Patients will be placed on a patient-controlled anesthesia pump (PCA) for 24 hours. On post-operative day one, the patients will be switched to oral oxycodone as needed with supplementation with IV Demerol for breakthrough pain. In addition, patients will receive either pregabalin 75mg PO BID, pregabalin 150mg PO BID or placebo beginning on the day of surgery until discharge.

The clinical research nurse will complete a form which records the daily use of each of the post-operative pain medications. She will also ask the patient to complete a Visual Analog Scale (VAS) to assess pain each day while in the hospital.

Upon discharge, the patient will be given study medication (pregabalin, 75mg PO BID, 150mg PO BID or placebo). Rescue medications will be allowed during the study (including post-operative and outpatient periods). Outpatient rescue medications will consist of hydrocodone/APAP 7.5mg PO Q6H PRN. Patients will be followed for three months as an outpatient.

  Eligibility

Ages Eligible for Study:   19 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • fractures requiring operative treatment during a single operative episode
  • Adult patients between the ages of 19 and 70

Exclusion Criteria:

  • prior medical history of narcotic abuse or narcotic use within 2 weeks of injury (except those given in hospital)
  • contraindications to pregabalin or narcotic analgesics
  • significant closed head injury
  • psychiatric illness requiring medical treatment
  • surgery for other injuries (splenectomy, etc)
  • history of seizures requiring current anticonvulsant therapy
  • inability or unwillingness to give informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00583869

Contacts
Contact: David A Volgas, MD 205-934-9545 David.Volgas@ortho.uab.edu

Locations
United States, Alabama
The University of Alabama at Birmingham, Orthopaedic Trauma Recruiting
Birmingham, Alabama, United States, 35294
Contact: David A Volgas, MD     205-934-9545     David.Volgas@ortho.uab.edu    
Principal Investigator: David A Volgas, MD            
Sponsors and Collaborators
University of Alabama at Birmingham
Pfizer
Investigators
Principal Investigator: David A Volgas, MD The University of Alabama at Birmingham
  More Information

Publications:
Responsible Party: The University of Alabama at Birmingham ( David A. Volgas, MD, Associate Professor of Surgery )
Study ID Numbers: F061204006
Study First Received: December 21, 2007
Last Updated: February 12, 2009
ClinicalTrials.gov Identifier: NCT00583869     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
Post-operative Pain
Fracture Patients
Pregabalin
LYRICA

Additional relevant MeSH terms:
Physiological Effects of Drugs
Pregabalin
Pain
Pharmacologic Actions
Signs and Symptoms
Pathologic Processes
Postoperative Complications
Sensory System Agents
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants
Pain, Postoperative

ClinicalTrials.gov processed this record on November 05, 2009