Evaluating the Role of Pregabalin in Reducing Opioid Requirement in Spinal Fusion Surgeries of Two or More Vertebrae

• Status: Terminated
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

Summary

To see if the administration of 3 dosses of pregabalin (1 dose preoperative, 2 doses postoperative) will reduce the postoperative opiate requirements of patients undergoing spinal fusion surgeries of two or more vertebrae.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Montefiore Medical Center
• Treatments: Pregabalin

Criteria

Inclusion Criteria:

• Age : > 18 years old

• Fusion of > two vertebrae

• Capacity to provide consent

• ASA I-IV

• Ability to swallow capsules

Exclusion Criteria:

• Plan of care includes intubated ICU admission post-op

• Allergy to gabapentin or pregabalin

• Two week prior use of pregabalin

• Significant renal dysfunction (creatinine level >2)

• Severe cardiovascular disease

• History of frequent headaches or dizziness

• Significant hepatic dysfunction (LFT's > 4 times the normal ranges)

• Active usage of alcohol or illicit substances three days prior to surgery

• History of seizure disorders

• Taking medication for anxiety, antiseizure, and psychiatric diagnoses

• Re-operation patients