Examining Analgesic Synergy and Efficacy in Trauma Care (EASE)

Examining Analgesic Synergy and Efficacy in Trauma Care-A Randomized, Control Study of Buprenorphine Versus Oxycodone in Multimodal Pain Control Regimens

Traumatic injury is responsible for over 25 million (16%) Emergency Department visits and over 225,000 deaths each year per 2021 Center for Disease Control data. This is the 3rd leading cause of death in the US. Often, acute care for the injured patient requires administration of pain medication for the purposes of acute pain control from injury. The mainstay of treatment for pain control has historically involved opioid pain medication.

Study Overview

• Status: Not yet recruiting
• Conditions: Opioid Use Disorder
• Intervention / Treatment: Drug: Oxycodone; Drug: Buprenorphine

Detailed Description

A different medication which has been used in place of full agonist opioids is a product known as buprenorphine, which was developed in the 1960's. This medication works as a partial agonist/antagonist of the µ opioid pain receptors. It has performed robustly in comparison to full opioid agonist (FAO) medications, and in a recent meta-analysis of this medication, it was responsible for reducing pain, less rescue analgesia use, and similar rates of adverse events in comparison to full opioid agonist therapy. This also concurrently lowered the amount of Morphine Milligram Equivalents (MME) used by the postoperative patients, although the achievement of lower pain scores is the significant finding. These data assert that buprenorphine is more efficacious than FAO in mitigating acute post op pain due to comparable analgesic effect and longer duration of action when compared to many other oral opioids.

This medication has been commonly used in patients with opioid abuse disorder and has shown improvements in specific patient outcome metrics when induction therapy is performed in hospital for patients with opioid use disorder (OUD). Further, continuation of buprenorphine for patients taking the medication as an outpatient for acute pain control has been shown to be safe, and to have similar efficacy to discontinuation in favor of standard pain regimen therapy.

• Study Type: Interventional
• Enrollment (Estimated): 282
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: D'Ann B Hershel, MS; Phone Number: 336-716-1659; Email: Dann.Hershel@wfusm.edu

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences
      • Contact: D'Ann B Hershel, MS; Phone Number: 336-716-1659; Email: Dann.Hershel@wfusm.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult patients with injury to at least 2 body locations as defined by Abbreviated Injury Scale (AIS) scores (Head, Face, Neck, Chest, Abdomen/Pelvis, Spine, Upper Extremity, Lower Extremity, External)

Exclusion Criteria:

• Glasgow Coma Scale (GCS) <15 - Patients may be included if their GCS improves to 15 within 24 hours of admission
• Age <18 years
• Age ≥80years
• Prisoners
• Pregnant patients
• Non-English speakers
• Inability to provide consent
• Home buprenorphine or methadone use
• Home opioid use >45 Morphine Milligram Equivalents (MME)/day
• Allergy to any medication within the study or control arm
• Patients undergoing treatment for alcohol withdrawal
• History of cirrhosis requiring dose adjustment of Tylenol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control group; Standard pain control regimen with oxycodone	Drug: Oxycodone; 1000 mg acetaminophen every 6 hours (unless <60 kg = 15 mg/kg Q6 hours) IV ketorolac 15 mg Q6 hours x 48 hours; Celebrex 200 mg twice a day after 500 mg methocarbamol three times a day If fail conservative study regimens after 24 hours, may switch to a PCA or consider other analgesic regimens (ketamine, epidural, etcetera); Other Names: standard pain regimen - acetaminophen - ketorolac - methocarbamol
Experimental: Study group; Standard pain control regimen with buprenorphine	Drug: Buprenorphine; 2 mg every 6 hours prn for moderate to severe pain If after 2 doses this is insufficient, switch to 4 mg Q6 hours as needed IV buprenorphine 150 mcg Q6 hours for breakthrough pain; Other Names: Buprenex, Suboxone, Subutex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Numeric Rating Scale (NRS) Pain Scores	The Numeric Rating Scale (NRS) is an 11-point, self-reported measure of pain intensity ranging from 0 ("no pain") to 10 ("worst imaginable pain").	Day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morphine equivalent measure (MME)	Morphine equivalent measure (MME) - Morphine Milligram Equivalents (MME) are a standardized unit used by clinicians to calculate the total daily potency of all opioid medications a patient is taking relative to morphine	Day 14
Number of doses of rescue narcotic	Number of doses of rescue narcotic	Day 14
Length of hospital stay	Length of hospital stay	Day 14
Length of Intensive Care Unit stay length of Intensive Care Unit stay	Length of Intensive Care Unit stay	Day 14
Opiate prescription utilization post hospitalization (as MME)	Morphine equivalent measure (MME) - Morphine Milligram Equivalents (MME) are a standardized unit used by clinicians to calculate the total daily potency of all opioid medications a patient is taking relative to morphine	Day 14

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opiate dependence Risk checklist	This will be assessed based upon how much opiate the patient has required post hospitalization, as well as the Community (COMM) assessment which will stratify risk of opiate dependence.	Day 14
Cost of the medications used	the study will assess the cost of the medications used (cost per dose x number of doses)	Day 14

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Matthew Painter, MD, FACS, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 13, 2026
• First Submitted That Met QC Criteria: February 25, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Acute Pain; Pain Control; Trauma Care
• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Pain; Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Neurobehavioral Manifestations; Substance-Related Disorders; Chemically-Induced Disorders; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Opioid-Related Disorders; Acute Pain; Agnosia; Heterocyclic Compounds; Heterocyclic Compounds, Fused-Ring; Pharmaceutical Preparations; Alkaloids; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Drug Combinations; Naloxone; Morphinans; Opiate Alkaloids; Heterocyclic Compounds, Bridged-Ring; Phenanthrenes; Morphine Derivatives; Codeine; Buprenorphine, Naloxone Drug Combination; Buprenorphine; Oxycodone
• Other Study ID Numbers: IRB00140421

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