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Does Early Administration of Ultrasound Guided Regional Anesthesia for Long Bone Fractures Effect Long Term Patient Opioid Usage

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04189523
Recruitment Status : Recruiting
First Posted : December 6, 2019
Last Update Posted : December 12, 2019
Sponsor:
Information provided by (Responsible Party):
Robert Ehrman, Wayne State University

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.

Condition or disease Intervention/treatment Phase
Bone Fracture Opioid Use Opioid Dependence Other: SOC Pain Management Procedure: Early US Guided Nerve Block Administration Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: We will perform a small prospective non-randomized interventional pilot study to assess feasibility of a future full scale RCT to test our hypotheses. Interventional study subjects will be compared to controls enrolled simultaneously during the study period who meet the inclusion criteria and do not have documentation of one of the exclusion criteria. We will enroll subjects 2 controls to 1 intervention to ensure the ability to select controls as similar to the intervention population as possible.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prospective Non-Randomized Interventional Pilot Study of the Effects of Early Administration of Ultrasound Guided Regional Anesthesia for Long Bone Fractures on Long Term Patient Opioid Usage
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard of Care Pain Management Other: 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.

Experimental: Early Administration of US Guided Nerve Blocks Procedure: Early US Guided Nerve Block Administration
US-Guided regional anesthesia (fascia illiaca compartment block or brachial plexus block)




Primary Outcome Measures :
  1. Opioids administered for pain control as measured in Morphine Milliequivalents [ Time Frame: 24-hours following injury ]
    Determine if early administration of nerve blocks results in change in morphine milliequivalents (MMEs) required for pain control compared to standard care.


Secondary Outcome Measures :
  1. Opioids administered for pain control as measured in Morphine Milliequivalents [ Time Frame: 7-days following injury ]
    Determine if early administration of peripheral nerve blocks results in change in MMEs required for pain control compared to standard care.

  2. Opioids administered for pain control as measured in Morphine Milliequivalents [ Time Frame: 30-days following injury ]
    Determine if early administration of nerve blocks results in change in MMEs required for pain control compared to standard care.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04189523


Contacts
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Contact: Robert Ehrman, MD 313-745-3330 rehrman@med.wayne.edu

Locations
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United States, Michigan
Detroit Receiving Hospital Recruiting
Detroit, Michigan, United States, 48201
Contact: Robert Ehrman, MD    313-745-3330    rehrman@med.wayne.edu   
Sinai Grace Hospital Recruiting
Detroit, Michigan, United States, 48235
Contact: Robert Ehrman, MD    313-745-3330    rehrman@med.wayne.edu   
Sponsors and Collaborators
Wayne State University
Investigators
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Principal Investigator: Robert Ehrman, MD Wayne SU

Publications:
American Academy of Orthopaedic Surgeons. 2014. Strong evidence supports regional analgesia to improve preoperative pain control in patients with hip fracture. Retrieved from: http://www.orthoguidelines.org/guideline-detail?id=1231
T Bendinger, N Plunkett; Measurement in pain medicine, BJA Education, Volume 16, Issue 9, 1 September 2016, Pages 310-315, https://doi.org/10.1093/bjaed/mkw014
A Feizerfan, G Sheh; Transition from acute to chronic pain, Continuing Education in Anaesthesia Critical Care & Pain, Volume 15, Issue 2, 1 April 2015, Pages 98-102, https://doi.org/10.1093/bjaceaccp/mku044
Key Substance Use and Mental Health Indicators in the United States: Results from the 2016 National Survey on Drug Use and Health: pages 20-24. Center for Behavioral Health Statistics and Quality, US Dept Health and Human Services; 2016. https://www.samhsa.gov/data/sites/default/files/NSDUH-FFR1-2016/NSDUH-FFR1-2016.pdf

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Responsible Party: Robert Ehrman, Volunteer Faculty, Wayne State University
ClinicalTrials.gov Identifier: NCT04189523    
Other Study ID Numbers: 022419MP2F
First Posted: December 6, 2019    Key Record Dates
Last Update Posted: December 12, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Robert Ehrman, Wayne State University:
Ultrasound
Trauma
Bone Fracture
Opioid
Additional relevant MeSH terms:
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Opioid-Related Disorders
Fractures, Bone
Wounds and Injuries
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents