Recruiting

Ultrasound Guided Regional Anesthesia

Sponsor:

Wayne State University

Code:

NCT04189523

Conditions

Bone Fracture

Opioid Use

Opioid Dependence

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

SOC Pain Management

Early US Guided Nerve Block Administration

Study Details

Brief summary:

Administration of ultrasound guided peripheral nerve blocks is a procedural skill set that falls within the scope of Emergency Medicine practice. Extrapolating evidence from Anesthesia and Orthopedic literature (which shows decreased post-operative opioid use by surgical patients who receive regional anesthesia as part of their pre and perioperative pain management strategy) the investigators believe that early administration of regional anesthesia for long bone fractures by providers in the ED may have an as of yet unidentified positive impact on long term opioid use. If this is indeed found to be the case, early administration of regional anesthesia for extremity fractures would represent an area of focus for ED providers in the national effort by the medical community to combat opioid abuse.

Conditions

Bone Fracture

Opioid Use

Opioid Dependence

Study ID

NCT04189523

Start date

Sep 1, 2019

Status verified date

Dec, 2019

Completion date

Jun, 2020

Anticipated

Primary completion date

Jun, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • patients 18 years of age or older
  • presentation to the emergency department with isolated fractures of the hip or proximal femur, mid or distal humerus, radius, or ulna
  • poly-trauma patients with one of the previously listed fractures who do not meet exclusion criteria

Exclusion Criteria:

  • Allergy to Bupivacaine/ropivicaine or other amide anesthetics
  • evidence of compartment syndrome on exam by physician
  • infection over injection site
  • previously documented opioid abuse or dependence in the last year as documented in the EMR or self-reported by the patient
  • current documented opioid prescription in the EMR
  • patient is intubated or unable to provide consent
  • poly-trauma patients with abdominal, thoracic or neurologic injury requiring operative intervention at the time of presentation to the ED

Study Design

Enrollment

54 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Standard of Care Pain Management

experimental: Early Administration of US Guided Nerve Blocks

Interventions

SOC Pain Management

Study subjects will be compared to historical controls selected for same age +/- 5yrs, gender, fracture type who meet the inclusion criteria and do not have historical documentation of one of the exclusion criteria. Controls will be identified by the ICD-10 injury codes selected for use in this study. Clinical course and pain management data will be collected through the EMR only.

Early US Guided Nerve Block Administration

US-Guided regional anesthesia (fascia illiaca compartment block or brachial plexus block)

Primary outcome measure

  • Opioids administered for pain control as measured in Morphine Milliequivalents [ Time Frame: 24-hours following injury ]

Central Contacts and Locations

Central contacts

Robert Ehrman, MD

313-745-3330rehrman@med.wayne.edu

Locations

Detroit Receiving Hospital

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Robert Ehrman, MD

313-745-3330rehrman@med.wayne.edu

Sinai Grace Hospital

Recruiting

Detroit, Michigan, United States, 48235

Contacts

Robert Ehrman, MD

313-745-3330rehrman@med.wayne.edu

More Information

Sponsor

Wayne State University

Last update posted

Dec 12, 2019

Last verified

Dec, 2019

Keywords

  • Ultrasound
  • Trauma
  • Bone Fracture
  • Opioid

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Wayne State University on 2019-12-12.