Role of Pregabalin in Treatment of Post-Op Pain in Fracture Patients
NCT00583869
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- 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
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Descriptive Information | ||||
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Brief Title ICMJE | Role of Pregabalin in Treatment of Post-Op Pain in Fracture Patients | |||
Official Title ICMJE | The Role of Pregabalin in the Treatment of Post-Operative Pain in Fracture Patients | |||
Brief 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. | |||
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. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Early Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
Condition ICMJE | Post-operative Pain | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 86 | |||
Original Estimated Enrollment ICMJE | 150 | |||
Actual Study Completion Date ICMJE | August 2009 | |||
Actual Primary Completion Date | August 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 19 Years to 70 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00583869 | |||
Other Study ID Numbers ICMJE | F061204006 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | University of Alabama at Birmingham | |||
Study Sponsor ICMJE | University of Alabama at Birmingham | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
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PRS Account | University of Alabama at Birmingham | |||
Verification Date | May 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |