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Pregabalin vs. Gabapentin on Reducing Opioid Usage

Primary Purpose

Analgesics, Gabapentin, Injuries

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Pregabalin 50mg
Gabapentin 300mg
Neither Pregabalin nor Gabapentin
Sponsored by
CAMC Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Analgesics focused on measuring Pregabalin , ,, Gabapentin, Opioid Pain Medication Use, Trauma, Opioid Usage Reduction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Charleston Area Medical Center"s Level 1 Trauma CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Pregabalin

Gabapentin

Neither Pregabalin nor Gabapentin

Arm Description

Outcomes

Primary Outcome Measures

Reduction in opioid usage
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.

Secondary Outcome Measures

Incentive spirometry values
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.
Rate of intubation
To compare the proportion of patients requiring intubation among the study groups.
Pain control
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."
Hospital length of stay
To evaluate the differences among the study arms with respect to hospital length of stay (days).
Rate of unplanned ICU admission
To evaluate the differences among the study arms with respect to proportion of unplanned ICU admission.

Full Information

First Posted
January 8, 2021
Last Updated
January 11, 2023
Sponsor
CAMC Health System
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1. Study Identification

Unique Protocol Identification Number
NCT04705480
Brief Title
Pregabalin vs. Gabapentin on Reducing Opioid Usage
Official Title
Pregabalin vs. Gabapentin on Reducing Opioid Usage in Trauma Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 12, 2021 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
CAMC Health System

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesics, Gabapentin, Injuries, Narcotics, Pain, Trauma
Keywords
Pregabalin , ,, Gabapentin, Opioid Pain Medication Use, Trauma, Opioid Usage Reduction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pregabalin
Arm Type
Experimental
Arm Title
Gabapentin
Arm Type
Experimental
Arm Title
Neither Pregabalin nor Gabapentin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Pregabalin 50mg
Other Intervention Name(s)
Lyrica
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Gabapentin 300mg
Other Intervention Name(s)
Neurontin
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Neither Pregabalin nor Gabapentin
Intervention Description
Patients will receive neither Pregabalin nor Gabapentin.
Primary Outcome Measure Information:
Title
Reduction in opioid usage
Description
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.
Time Frame
First 7 days post-enrollment or until discharge, if discharge < 7 days post-enrollment
Secondary Outcome Measure Information:
Title
Incentive spirometry values
Description
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.
Time Frame
First 7 days post-enrollment or until discharge, if discharge < 7 days post-enrollment
Title
Rate of intubation
Description
To compare the proportion of patients requiring intubation among the study groups.
Time Frame
First 7 days post-enrollment or until discharge, if discharge < 7 days post-enrollment
Title
Pain control
Description
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."
Time Frame
First 7 days post-enrolment or until discharge, if discharge < 7 days post-enrollment
Title
Hospital length of stay
Description
To evaluate the differences among the study arms with respect to hospital length of stay (days).
Time Frame
First 7 days post-enrollment or until discharge, if discharge < 7 days post-enrollment
Title
Rate of unplanned ICU admission
Description
To evaluate the differences among the study arms with respect to proportion of unplanned ICU admission.
Time Frame
First 7 days post-enrollment or until discharge, if discharge < 7 days post-enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Nurse Practitioner service admissions 18 years of age or older Patients enrolled within 36 hours of admission Anticipated duration of hospitalization > 24 hours from time of consent Active order(s) for opioids in place at the time of enrollment Exclusion Criteria: Clinician discretion based on patient care management Intubated patients Patients with epidural Patients with pregabalin/gabapentin as home medications Patients receiving pregabalin/gabapentin upon admission Traumatic brain injury patients CrCl<30ml/min or on HD Unable to take enteral medications On Patient Controlled Analgesia (PCA) Patients with complicated wound closure History of epilepsy Documented history of substance use disorder
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
John A DeLuca, MD
Phone
3043887278
Email
john.deluca@camc.org
Facility Information:
Facility Name
Charleston Area Medical Center"s Level 1 Trauma Center
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25301
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Damayanti Samanta, MS
Phone
304-388-7808
Email
damayanti.samanta@camc.org
First Name & Middle Initial & Last Name & Degree
Nancy Duvall, RN-BC, MS
Phone
3043883653
Email
nancy.duvall@camc.org

12. IPD Sharing Statement

Plan to Share IPD
No

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Pregabalin vs. Gabapentin on Reducing Opioid Usage

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