Role of Pregabalin in Treatment of Post-Op Pain in Fracture Patients
Condition: Post-operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Early Phase 1

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.
    

Intervention name(s): Placebo; Pregabalin; Pregabalin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 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.; 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.; 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.
Other intervention name(s): LYRICA; LYRICA
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Post-operative Pain; Fracture Patients; Pregabalin; LYRICA