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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Post-operative Pain

Intervention / Treatment
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* Drug: Placebo
* Drug: Pregabalin
* Drug: Pregabalin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Patient to receive placebo beginning on the day of surgery until discharge. | Drug: Placebo<br>* 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.<br>|
| Experimental: 2<br>Patient to receive 75mg PO BID pregabalin beginning on the day of surgery until discharge. | Drug: Pregabalin<br>* 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.<br>* Other names: LYRICA;|
| Experimental: 3<br>Patient to receive 150mg PO BID pregabalin beginning on the day of surgery until discharge. | Drug: Pregabalin<br>* 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.<br>* Other names: LYRICA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of pain medication in morphine equivalent units used during the hospitalization. |  | Screening - 5 - 15 minutes; Consent - 5-15 minutes; Follow-up - three 15-30-minute visits | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcome measures will include Visual Analog Score, timing and frequency of rescue medications, Short-Form 36 Health Survey scores, and adverse events. |  | Three 15-30-minute visits after surgery to complete SF-36 and Visual Analog Score for Pain. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post-operative Pain, Fracture Patients, Pregabalin, LYRICA