Role of Pregabalin in Treatment of Post-Op Pain in Fracture Patients
Information source: University of Alabama at Birmingham
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Post-operative Pain
Intervention: Placebo (Drug); Pregabalin (Drug); Pregabalin (Drug)
Phase: Phase 0
Sponsored by: University of Alabama at Birmingham
Official(s) and/or principal investigator(s):
Steven Theiss, MD, Principal Investigator, Affiliation: The University of Alabama at Birmingham
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.
Official title: The Role of Pregabalin in the Treatment of Post-Operative Pain in Fracture Patients
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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.
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.
Minimum age: 19 Years.
Maximum age: 70 Years.
- fractures requiring operative treatment during a single operative episode
- Adult patients between the ages of 19 and 70
- 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
The University of Alabama at Birmingham, Birmingham, Alabama 35294, United States
Turan A, White PF, Karamanlioglu B, Memis D, Tasdogan M, Pamukçu 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: May 2007
Last updated: January 5, 2014