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Role of Pregabalin in Treatment of Post-Op Pain in Fracture Patients

Information source: University of Alabama at Birmingham
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Post-Operative Pain

Intervention: Placebo (Drug); Pregabalin (Drug); Pregabalin (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: University of Alabama at Birmingham

Official(s) and/or principal investigator(s):
David A Volgas, MD, Principal Investigator, Affiliation: The University of Alabama at Birmingham

Overall contact:
David A Volgas, MD, Phone: 205-934-9545, Email: David.Volgas@ortho.uab.edu

Summary

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.

Clinical Details

Official title: The Role of Pregabalin in the Treatment of Post-Operative Pain in Fracture Patients

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study

Primary outcome: Amount of pain medication in morphine equivalent units used during the hospitalization.

Secondary outcome: Secondary outcome measures will include Visual Analog Score, timing and frequency of rescue medications, Short-Form 36 Health Survey scores, and adverse events.

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

Minimum age: 19 Years. Maximum age: 70 Years. Gender(s): Both.

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

Locations and Contacts

David A Volgas, MD, Phone: 205-934-9545, Email: David.Volgas@ortho.uab.edu

The University of Alabama at Birmingham, Orthopaedic Trauma, Birmingham, Alabama 35294, United States; Recruiting
David A Volgas, MD, Phone: 205-934-9545, Email: David.Volgas@ortho.uab.edu
David A Volgas, MD, Principal Investigator
Additional Information

Related publications:

Turan A, White PF, Karamanlioglu B, Memis D, Tasdogan M, Pamuk├žu Z, Yavuz E. Gabapentin: an alternative to the cyclooxygenase-2 inhibitors for perioperative pain management. Anesth Analg. 2006 Jan;102(1):175-81.

Fischer HB, Simanski CJ. A procedure-specific systematic review and consensus recommendations for analgesia after total hip replacement. Anaesthesia. 2005 Dec;60(12):1189-202. Review.

Sills GJ. The mechanisms of action of gabapentin and pregabalin. Curr Opin Pharmacol. 2006 Feb;6(1):108-13. Epub 2005 Dec 22. Review.

Starting date: February 2009
Ending date: February 2010
Last updated: February 12, 2009

Page last updated: October 19, 2009

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