Role of Pregabalin in Treatment of Post-Op Pain in Fracture Patients (LYRICA)

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00583869
First received: December 21, 2007
Last updated: January 5, 2014
Last verified: May 2012
  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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 ]

Enrollment: 86
Study Start Date: May 2007
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
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.

Experimental: 2
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.

Other Name: LYRICA
Experimental: 3
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.

Other Name: LYRICA

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 orally (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/acetamenophen (APAP) 7.5mg PO every sic hours (Q6H) as needed (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
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: NCT00583869

Locations
United States, Alabama
The University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Pfizer
Investigators
Principal Investigator: Steven Theiss, MD The University of Alabama at Birmingham
  More Information

Publications:
Responsible Party: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00583869     History of Changes
Other Study ID Numbers: F061204006
Study First Received: December 21, 2007
Last Updated: January 5, 2014
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:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Pregabalin
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

ClinicalTrials.gov processed this record on August 28, 2014