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

NCT03031340 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2019-08-20

Study results available
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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.

Conditions

  • Spinal Fusion

Interventions

DRUG

Pregabalin

On the day of the surgery, 1hour + 15 minutes before the surgery starts, the subject will receive either 300mg of pregabalin or a similarly packaged placebo. On post operative day one, 150 mg of pregabalin or placebo will be given in two doses 12hrs apart.

OTHER

placebo

placebo

Sponsors & Collaborators

  • Montefiore Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03031340 on ClinicalTrials.gov