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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Spinal Fusion

In brief

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.

Key facts

Study ID

NCT03031340

Run by

Montefiore Medical Center

People needed

3

Starts

2012-05-01

Expected to finish

2012-09-01

Last updated by the study team

2019-08-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age : > 18 years old
• Fusion of > two vertebrae
• Capacity to provide consent
• ASA I-IV
• Ability to swallow capsules

You may not qualify if…

• 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

Where it is running

• Montefiore Medical Center — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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