Pregabalin vs. Gabapentin on Reducing Opioid Usage

• ClinicalTrials.gov Identifier: NCT04705480
• Recruitment Status: Recruiting
• First Posted: January 12, 2021
• Last Update Posted: August 5, 2021
• Sponsor: CAMC Health System
• Information provided by (Responsible Party): John DeLuca, CAMC Health System

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.

Condition or disease	Intervention/treatment	Phase
Analgesics; Gabapentin; Injuries; Narcotics; Pain; Trauma	Drug: Pregabalin 50mg; Drug: Gabapentin 300mg; Drug: Neither Pregabalin nor Gabapentin	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 210 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pregabalin vs. Gabapentin on Reducing Opioid Usage in Trauma Patients
• Actual Study Start Date: April 12, 2021
• Estimated Primary Completion Date: April 12, 2022
• Estimated Study Completion Date: April 12, 2022

Arms and Interventions

Arm	Intervention/treatment
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 Name: Lyrica
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 Name: Neurontin
Active Comparator: Neither Pregabalin nor Gabapentin	Drug: Neither Pregabalin nor Gabapentin; Patients will receive neither Pregabalin nor Gabapentin.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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."
4. 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).
5. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Nurse Practitioner service admissions
2. 18 to 65 year of age
3. Patients enrolled within 24 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

Contacts and Locations

Contacts

Contact: John A DeLuca, MD; 3043887278; john.deluca@camc.org

Locations

United States, West Virginia

Charleston Area Medical Center"s Level 1 Trauma Center; Recruiting

Charleston, West Virginia, United States, 25301

Contact: Aous Jarrouj, MD, MBA, MHM 304-388-7808 aous.jarrouj@camc.org

Contact: Nancy Duvall, RN-BC, MS 3043889989 nancy.duvall@camc.org

Sponsors and Collaborators

CAMC Health System

More Information

• Responsible Party: John DeLuca, Trauma Surgeon, CAMC Health System
• ClinicalTrials.gov Identifier: NCT04705480
• Other Study ID Numbers: 20-718
• First Posted: January 12, 2021
• Last Update Posted: August 5, 2021
• Last Verified: July 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by John DeLuca, CAMC Health System:

Pregabalin , ,; Gabapentin; Opioid Pain Medication Use; Trauma; Opioid Usage Reduction

Additional relevant MeSH terms:

Wounds and Injuries; Pregabalin; Gabapentin; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anticonvulsants; Calcium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Calcium-Regulating Hormones and Agents; Anti-Anxiety Agents; Tranquilizing Agents; Central Nervous System Depressants; Psychotropic Drugs; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Neurotransmitter Agents; Antimanic Agents