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Sponsors and Collaborators: |
University of Alabama at Birmingham Pfizer |
Information provided by: | University of Alabama at Birmingham |
ClinicalTrials.gov Identifier: | NCT00583869 |
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 |
MedlinePlus related topics: | Fractures |
Drug Information available for: | Oxycodone Oxycodone hydrochloride Pregabalin Hydrocodone Hydrocodone bitartrate Meperidine Meperidine hydrochloride |
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 |
Estimated Enrollment: | 150 |
Study Start Date: | February 2007 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | February 2009 (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.
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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.
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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.
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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. |
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.
Ages Eligible for Study: | 19 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: David A Volgas, MD | 205-934-9545 | David.Volgas@ortho.uab.edu |
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 |
University of Alabama at Birmingham |
Pfizer |
Principal Investigator: | David A Volgas, MD | The University of Alabama at Birmingham |
Responsible Party: | The University of Alabama at Birmingham ( David A. Volgas, MD, Associate Professor of Surgery ) |
Study ID Numbers: | F061204006 |
First Received: | December 21, 2007 |
Last Updated: | June 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00583869 |
Health Authority: | United States: Institutional Review Board |
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