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

NCT00583869 | Completed Early Phase 1 DMC

• 1 other identifier: F061204006
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post-operative Pain

Keywords

Post-operative Pain; Fracture Patients; Pregabalin; LYRICA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (3)

1

PLACEBO COMPARATOR

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

Drug: Placebo

2

EXPERIMENTAL

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

Drug: Pregabalin

3

EXPERIMENTAL

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

Drug: Pregabalin

Interventions

Placebo DRUG

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.

1

Pregabalin DRUG

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.

Also known as: LYRICA

2

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• fractures requiring operative treatment during a single operative episode
• Adult patients between the ages of 19 and 70

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Pfizer: collaborator

Study Sites (1)

The University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (3)

• Turan A, White PF, Karamanlioglu B, Memis D, Tasdogan M, Pamukcu Z, Yavuz E. Gabapentin: an alternative to the cyclooxygenase-2 inhibitors for perioperative pain management. Anesth Analg. 2006 Jan;102(1):175-81. doi: 10.1213/01.ane.0000184824.43411.63.

  PMID: 16368826 BACKGROUND

• Fischer HB, Simanski CJ. A procedure-specific systematic review and consensus recommendations for analgesia after total hip replacement. Anaesthesia. 2005 Dec;60(12):1189-202. doi: 10.1111/j.1365-2044.2005.04382.x.

  PMID: 16288617 BACKGROUND

• Sills GJ. The mechanisms of action of gabapentin and pregabalin. Curr Opin Pharmacol. 2006 Feb;6(1):108-13. doi: 10.1016/j.coph.2005.11.003. Epub 2005 Dec 22.

  PMID: 16376147 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Steven Theiss, MD

  The University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 2, 2008
• Study Start: May 1, 2007
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: January 7, 2014

Record last verified: 2012-05

Locations

US (1)