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

NCT03031340 | Terminated Phase 3 Results DMC

• 1 other identifier: 11-01-004
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Spinal fusion; pregabalin; Spinal fusion surgeries; two or more vertebrae

Outcome Measures

Primary Outcomes (1)

• Postoperative Opioid Requirement

  The primary objective of this study is to evaluate the role of three doses of pregabalin on intra and postoperative (48hrs) opioid requirements in patients undergoing fusion of two or more vertebrae.

  48 hours

Secondary Outcomes (5)

• Pain Using the Visual Analog Scale (VAS) Pain Score

  2 hours, 24 hours, 48 hours

• Incidence of 48 Hours Post Operative Nausea and Vomiting

  48 hours

• Post Operative Cognitive Function

  48 hours

• Pre-operative Anxiety

  24 hours prior to surgery

• Anesthesia Satisfaction

  24 hours post surgery

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Other: placebo

Pregabalin

EXPERIMENTAL

Drug: Pregabalin

Interventions

Pregabalin DRUG

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.

Pregabalin

placebo OTHER

placebo

Placebo

Eligibility Criteria

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

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

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

MeSH Terms

Interventions

Pregabalin

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr.Singh Nair
• Organization: Montefiore Medical Center

sinair@montefiore.org

7189205932

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 22, 2017
• First Posted: January 25, 2017
• Study Start: May 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: August 20, 2019
• Results First Posted: October 10, 2018

Record last verified: 2019-08

Locations

US (1)