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NCT Number: NCT07435077

Examining Analgesic Synergy and Efficacy in Trauma Care

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location contact

D'Ann B Hershel, MS

CONTACT

[email protected]

336-716-1659

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

buprenorphine

Drug

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

Oxycodone

Drug

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

Primary outcomes

  1. The Numeric Rating Scale (NRS) Pain Scores

    Time frame: Day 14

    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").

Secondary outcomes

  1. Morphine equivalent measure (MME)

    Time frame: Day 14

    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

  2. Number of doses of rescue narcotic

    Time frame: Day 14

    Number of doses of rescue narcotic

  3. Length of hospital stay

    Time frame: Day 14

    Length of hospital stay

  4. Length of Intensive Care Unit stay length of Intensive Care Unit stay

    Time frame: Day 14

    Length of Intensive Care Unit stay

  5. Opiate prescription utilization post hospitalization (as MME)

    Time frame: Day 14

    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

Other outcomes

  1. Opiate dependence Risk checklist

    Time frame: Day 14

    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.

  2. Cost of the medications used

    Time frame: Day 14

    the study will assess the cost of the medications used (cost per dose x number of doses)

Study contacts

Contact information is provided by the study sponsor or research team.

D'Ann B Hershel, MS

CONTACT

[email protected]

336-716-1659

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

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

Acronym: EASE

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2026
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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