Role of Pregabalin in Treatment of Post-Op Pain in Fracture Patients (LYRICA)

The University of Alabama at Birmingham

Status and phase: Completed; Early Phase 1

Conditions: Post-operative Pain

Treatments: Drug: Placebo; Drug: Pregabalin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00583869

F061204006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 86 patients

Sex: All

Ages: 19 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

86 participants in 3 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Patient to receive placebo beginning on the day of surgery until discharge.

Treatment:

Drug: Placebo

2

Experimental group

Description:

Patient to receive 75mg PO BID pregabalin beginning on the day of surgery until discharge.

Treatment:

Drug: Pregabalin

Drug: Pregabalin

3

Experimental group

Description:

Patient to receive 150mg PO BID pregabalin beginning on the day of surgery until discharge.

Treatment:

Drug: Pregabalin

Drug: Pregabalin