Clinical trial NCT00583869: Role of Pregabalin in Treatment of Post-Op Pain in Fracture Patients
Official title: The Role of Pregabalin in the Treatment of Post-Operative Pain in Fracture Patients
Conditions: Post-operative Pain
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.
Interventions:
description: 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.<br/>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.
name: Placebo
type: Drug
description: 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.<br/>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.
name: Pregabalin
other_name: LYRICA
type: Drug
description: 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.<br/>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.
name: Pregabalin
other_name: LYRICA
type: Drug
Study arms:
design_group_description: Patient to receive placebo beginning on the day of surgery until discharge.
design_group_title: 1
design_group_type: Placebo Comparator
design_group_description: Patient to receive 75mg PO BID pregabalin beginning on the day of surgery until discharge.
design_group_title: 2
design_group_type: Experimental
design_group_description: Patient to receive 150mg PO BID pregabalin beginning on the day of surgery until discharge.
design_group_title: 3
design_group_type: Experimental
Sponsor: The University of Alabama at Birmingham
Collaborators: Pfizer Inc.
Drug name mappings:
name: 普瑞巴林
lang: CN
name: Pregabalin
lang: EN
name: プレガバリン
lang: JP