Pregabalin vs. Gabapentin on Reducing Opioid Usage

December 31, 2025 updated by: Nancy Payne, 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

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients included in this trial were admitted under the care of the Trauma Nurse Practitioners (TNPs) who lead management of these patients. The TNP service is a 24/7 model where TNPs admit and manage patients under the trauma attending doctors from patient arrival in the emergency department until discharge, unless a higher level of care is indicated. The TNP patient census was monitored to identify new admissions who met the study criteria. Eligibility for participation was determined based on pre-established inclusion and exclusion criteria . Over the course of the trial, three changes were made to the eligibility criteria. To increase enrollment, the inclusion age range was revised from 18-70 years to 18 years and older. Additionally, the enrollment window was adjusted from 24 hours to 36 hours to facilitate the inclusion of patients admitted over the weekend. Receipt of a peripheral nerve block was also added to the exclusion criteria due to its potential to influence reported pain levels.

Patients included in the study were divided into 3 groups: pregabalin, gabapentin, and a control group receiving neither treatment. An SPSS algorithm using simple randomization was employed to generate a randomization list and assign patients to one of three groups. A sample size of 70 patients per study group (total of 210 patients) including 10% attrition was targeted. The sample size was determined based on Cohen's d formula using a power of 80%, a medium effect size indicating a 69% difference between groups. Effect sizes were calculated for planned comparisons (pregabalin vs. gabapentin, pregabalin vs. neither pregabalin nor gabapentin, gabapentin vs. neither pregabalin nor gabapentin) using t-statistics. An interim analysis was conducted after enrollment reached approximately 25% of the projected sample size to evaluate the study progress.

Enrollment and consenting of participants were performed by the research coordinators. Upon obtaining informed consent, participants were randomized sequentially to one of the three study arms by the coordinators, using the pre-generated randomization list. Enrolled patients were informed of their study arm and the TNP's initiated study drugs accordingly. Participants were followed throughout their hospital stay and remained in the study for a duration of seven days or until discharge, whichever occurred first. Patients underwent no additional cost for participating in the study as both pregabalin and gabapentin were frequently used as adjunct analgesia in this patient population at the study institution. Standard of care remained the same regardless of study participation. Patients were removed from the study if they were transferred to a higher level of care requiring a different service line.

For dosing purposes, patients with creatinine clearance (CrCl) greater than 60 ml/min received 50 mg of pregabalin every 8 hours in the pregabalin group or 300 mg of gabapentin every 8 hours in the gabapentin group. Those with CrCl less than or equal to 60ml/min received the same dose given every 12 hours, and the regimen was changed to every 8 hours if their CrCl increased above 60ml/min while enrolled. Creatine clearance was monitored daily during hospital course with dosage adjustments as necessary.

For this study, pain scores documented by nursing staff when patients requested additional pain medications were included. Pain scores were based upon a standard Numeric Rating Scale (0 = "no pain", 10 = "worst pain imaginable"). Patients who were already using prescription narcotics were eligible to participate and were continued on their home regimens as deemed necessary by providers. Adjunct non-opioid analgesia was administered at the discretion of the managing service. In-hospital narcotic exposure was ascertained by examining total amount of narotics administered in oral Morphine Milligram Equivalents (MME).

Data were collected via patient chart review and from the institution's trauma registry. Baseline patient characteristics extracted included age, gender, body mass index (BMI), days of enrollment, time from enrollment to first study drug administration, presence of rib fracture, timestamp of surgical intervention if applicable, prescription narcotics upon admission and comorbidities. Primary outcome measures included daily opioid intake during enrollment. Secondary outcomes included daily non-opioid analgesic intake, documented pain scores, post-enrollment complications (unplanned ICU admission or intubation), and daily incentive spirometry values for those with rib fractures. Additionally, adverse events such as somnolence, dizziness, fatigue, ataxia, tremor, amnesia, etc. were also monitored.

Study Type

Interventional

Enrollment (Actual)

109

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 Locations

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

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 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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: Pregabalin
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).
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
Experimental: Gabapentin
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).
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
Active Comparator: Neither Pregabalin nor Gabapentin
Patients will receive 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
Difference in Initial and Last Incentive Spirometry Values
Time Frame: Initial and last incentive spirometry, with an approximate duration of 7days or discharge; if discharge < 7 days post-enrollment.
To compare the difference between the initial and last documented incentive spirometry values (mL) among patients in each of the study groups who have at least 1 rib fracture.
Initial and last incentive spirometry, with an approximate duration of 7days or 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

Collaborators

West Virginia Clinical and Translational Science Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 (Actual)

September 30, 2024

Study Completion (Actual)

December 13, 2024

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 (Estimated)

January 6, 2026

Last Update Submitted That Met QC Criteria

December 31, 2025

Last Verified

September 1, 2025

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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