Pregabalin vs. Gabapentin on Reducing Opioid Usage

January 11, 2023 updated by: John DeLuca, CAMC Health System

Pregabalin vs. Gabapentin on Reducing Opioid Usage in Trauma Patients

This is a single-center, randomized, open-label, Phase 4 clinical trial investigating the efficacy of multiple-dose administrations of Pregabalin or Gabapentin in combination with traditional opioid pain medications to decrease the amount of opioid pain medication usage in single-system orthopedic trauma patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

210

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • West Virginia
      • Charleston, West Virginia, United States, 25301
        • Recruiting
        • Charleston Area Medical Center"s Level 1 Trauma Center
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Nurse Practitioner service admissions
  2. 18 years of age or older
  3. Patients enrolled within 36 hours of admission
  4. Anticipated duration of hospitalization > 24 hours from time of consent
  5. Active order(s) for opioids in place at the time of enrollment

Exclusion Criteria:

  1. Clinician discretion based on patient care management
  2. Intubated patients
  3. Patients with epidural
  4. Patients with pregabalin/gabapentin as home medications
  5. Patients receiving pregabalin/gabapentin upon admission
  6. Traumatic brain injury patients
  7. CrCl<30ml/min or on HD
  8. Unable to take enteral medications
  9. On Patient Controlled Analgesia (PCA)
  10. Patients with complicated wound closure
  11. History of epilepsy
  12. Documented history of substance use disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gabapentin
Drug: Gabapentin 300mg
Patients will receive 300 mg PO every 8 hours without dose titration. Patients with CrCl < 60mL/min will receive same dose given q12 hours. The q12 hour regimen may be increased to q8 hours if CrCl increases above 60mL/min during the 7 days study period or until discharge (if < 7 days post-enrollment).
Other Names:
  • Neurontin
Experimental: Pregabalin
Drug: Pregabalin 50mg
Patients will receive 50 mg every 8 hours without dose titration. Patients with CrCl < 60mL/min will receive same dose given q12 hours. The q12 hour regimen may be increased to q8 hours if CrCl increases above 60mL/min during the 7 days study period or until discharge (if < 7 days post-enrollment).
Other Names:
  • Lyrica
Active Comparator: Neither Pregabalin nor Gabapentin
Drug: Neither Pregabalin nor Gabapentin
Patients will receive neither Pregabalin nor Gabapentin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in opioid usage
Time Frame: First 7 days post-enrollment or until discharge, if discharge < 7 days post-enrollment
To determine if adding multiple doses of pregabalin or gabapentin upon admission will reduce opioid usage administered in oral Morphine Milligram Equivalents in trauma patients.
First 7 days post-enrollment or until discharge, if discharge < 7 days post-enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incentive spirometry values
Time Frame: First 7 days post-enrollment or until discharge, if discharge < 7 days post-enrollment
To compare the change in documented incentive spirometry values (liters) from morning physical assessment among patients in each of the study groups who have at least 1 rib fracture.
First 7 days post-enrollment or until discharge, if discharge < 7 days post-enrollment
Rate of intubation
Time Frame: First 7 days post-enrollment or until discharge, if discharge < 7 days post-enrollment
To compare the proportion of patients requiring intubation among the study groups.
First 7 days post-enrollment or until discharge, if discharge < 7 days post-enrollment
Pain control
Time Frame: First 7 days post-enrolment or until discharge, if discharge < 7 days post-enrollment
To assess effectiveness of pain control in each arm based on the average Numeric Pain Rating Scale score per 24 hours. This scale is a 10 point numeric scale that ranges from 0 that represents "no pain" to 10 which indicates the "worst pain imaginable."
First 7 days post-enrolment or until discharge, if discharge < 7 days post-enrollment
Hospital length of stay
Time Frame: First 7 days post-enrollment or until discharge, if discharge < 7 days post-enrollment
To evaluate the differences among the study arms with respect to hospital length of stay (days).
First 7 days post-enrollment or until discharge, if discharge < 7 days post-enrollment
Rate of unplanned ICU admission
Time Frame: First 7 days post-enrollment or until discharge, if discharge < 7 days post-enrollment
To evaluate the differences among the study arms with respect to proportion of unplanned ICU admission.
First 7 days post-enrollment or until discharge, if discharge < 7 days post-enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CAMC Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 12, 2021

Primary Completion (Anticipated)

December 31, 2025

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

January 8, 2021

First Submitted That Met QC Criteria

January 8, 2021

First Posted (Actual)

January 12, 2021

Study Record Updates

Last Update Posted (Actual)

January 12, 2023

Last Update Submitted That Met QC Criteria

January 11, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-718

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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