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

NCT04189523 | Unknown

• 1 other identifier: 022419MP2F
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

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

Keywords

Ultrasound; Trauma; Bone Fracture; Opioid

Outcome Measures

Primary Outcomes (1)

• Opioids administered for pain control as measured in Morphine Milliequivalents

  Determine if early administration of nerve blocks results in change in morphine milliequivalents (MMEs) required for pain control compared to standard care.

  24-hours following injury

Secondary Outcomes (2)

• Opioids administered for pain control as measured in Morphine Milliequivalents

  7-days following injury

• Opioids administered for pain control as measured in Morphine Milliequivalents

  30-days following injury

Study Arms (2)

Standard of Care Pain Management

ACTIVE COMPARATOR

Other: SOC Pain Management

Early Administration of US Guided Nerve Blocks

EXPERIMENTAL

Procedure: Early US Guided Nerve Block Administration

Interventions

SOC Pain Management OTHER

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.

Standard of Care Pain Management

Early US Guided Nerve Block Administration PROCEDURE

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

Early Administration of US Guided Nerve Blocks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wayne State University: lead

Study Sites (2)

Detroit Receiving Hospital

Detroit, Michigan, 48201, United States

RECRUITING

Sinai Grace Hospital

Detroit, Michigan, 48235, United States

RECRUITING

Related Publications (20)

• Delgado MK, Huang Y, Meisel Z, Hennessy S, Yokell M, Polsky D, Perrone J. National Variation in Opioid Prescribing and Risk of Prolonged Use for Opioid-Naive Patients Treated in the Emergency Department for Ankle Sprains. Ann Emerg Med. 2018 Oct;72(4):389-400.e1. doi: 10.1016/j.annemergmed.2018.06.003. Epub 2018 Jul 24.

  PMID: 30054152 BACKGROUND

• Dixit V, Fathima S, Walsh SM, Seviciu A, Schwendt I, Spittler KH, Briggs D. Effectiveness of continuous versus single injection femoral nerve block for total knee arthroplasty: A double blinded, randomized trial. Knee. 2018 Aug;25(4):623-630. doi: 10.1016/j.knee.2018.04.001. Epub 2018 Apr 26.

  PMID: 29705075 BACKGROUND

• Mohamadi A, Chan JJ, Lian J, Wright CL, Marin AM, Rodriguez EK, von Keudell A, Nazarian A. Risk Factors and Pooled Rate of Prolonged Opioid Use Following Trauma or Surgery: A Systematic Review and Meta-(Regression) Analysis. J Bone Joint Surg Am. 2018 Aug 1;100(15):1332-1340. doi: 10.2106/JBJS.17.01239.

  PMID: 30063596 BACKGROUND

• Thong ISK, Jensen MP, Miro J, Tan G. The validity of pain intensity measures: what do the NRS, VAS, VRS, and FPS-R measure? Scand J Pain. 2018 Jan 26;18(1):99-107. doi: 10.1515/sjpain-2018-0012.

  PMID: 29794282 BACKGROUND

• Hah JM, Bateman BT, Ratliff J, Curtin C, Sun E. Chronic Opioid Use After Surgery: Implications for Perioperative Management in the Face of the Opioid Epidemic. Anesth Analg. 2017 Nov;125(5):1733-1740. doi: 10.1213/ANE.0000000000002458.

  PMID: 29049117 BACKGROUND

• Compton WM, Jones CM, Baldwin GT. Relationship between Nonmedical Prescription-Opioid Use and Heroin Use. N Engl J Med. 2016 Jan 14;374(2):154-63. doi: 10.1056/NEJMra1508490. No abstract available.

  PMID: 26760086 BACKGROUND

• Ritcey B, Pageau P, Woo MY, Perry JJ. Regional Nerve Blocks For Hip and Femoral Neck Fractures in the Emergency Department: A Systematic Review. CJEM. 2016 Jan;18(1):37-47. doi: 10.1017/cem.2015.75. Epub 2015 Sep 2.

  PMID: 26330019 BACKGROUND

• Lewis SR, Price A, Walker KJ, McGrattan K, Smith AF. Ultrasound guidance for upper and lower limb blocks. Cochrane Database Syst Rev. 2015 Sep 11;2015(9):CD006459. doi: 10.1002/14651858.CD006459.pub3.

  PMID: 26361135 BACKGROUND

• Gamo K, Kuriyama K, Higuchi H, Uesugi A, Nakase T, Hamada M, Kawai H. Ultrasound-guided supraclavicular brachial plexus block in upper limb surgery: outcomes and patient satisfaction. Bone Joint J. 2014 Jun;96-B(6):795-9. doi: 10.1302/0301-620X.96B6.31893.

  PMID: 24891581 BACKGROUND

• Andreae MH, Andreae DA. Regional anaesthesia to prevent chronic pain after surgery: a Cochrane systematic review and meta-analysis. Br J Anaesth. 2013 Nov;111(5):711-20. doi: 10.1093/bja/aet213. Epub 2013 Jun 28.

  PMID: 23811426 BACKGROUND

• Beaudoin FL, Haran JP, Liebmann O. A comparison of ultrasound-guided three-in-one femoral nerve block versus parenteral opioids alone for analgesia in emergency department patients with hip fractures: a randomized controlled trial. Acad Emerg Med. 2013 Jun;20(6):584-91. doi: 10.1111/acem.12154.

  PMID: 23758305 BACKGROUND

• Haines L, Dickman E, Ayvazyan S, Pearl M, Wu S, Rosenblum D, Likourezos A. Ultrasound-guided fascia iliaca compartment block for hip fractures in the emergency department. J Emerg Med. 2012 Oct;43(4):692-7. doi: 10.1016/j.jemermed.2012.01.050. Epub 2012 Apr 9.

  PMID: 22494596 BACKGROUND

• Beaudoin FL, Nagdev A, Merchant RC, Becker BM. Ultrasound-guided femoral nerve blocks in elderly patients with hip fractures. Am J Emerg Med. 2010 Jan;28(1):76-81. doi: 10.1016/j.ajem.2008.09.015.

  PMID: 20006206 BACKGROUND

• Stone MB, Price DD, Wang R. Ultrasound-guided supraclavicular block for the treatment of upper extremity fractures, dislocations, and abscesses in the ED. Am J Emerg Med. 2007 May;25(4):472-5. doi: 10.1016/j.ajem.2006.08.019.

  PMID: 17499669 BACKGROUND

• Foss NB, Kristensen BB, Bundgaard M, Bak M, Heiring C, Virkelyst C, Hougaard S, Kehlet H. Fascia iliaca compartment blockade for acute pain control in hip fracture patients: a randomized, placebo-controlled trial. Anesthesiology. 2007 Apr;106(4):773-8. doi: 10.1097/01.anes.0000264764.56544.d2.

  PMID: 17413915 BACKGROUND

• Fletcher AK, Rigby AS, Heyes FL. Three-in-one femoral nerve block as analgesia for fractured neck of femur in the emergency department: a randomized, controlled trial. Ann Emerg Med. 2003 Feb;41(2):227-33. doi: 10.1067/mem.2003.51.

  PMID: 12548273 BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Fractures, Bone; Opioid-Related Disorders; Wounds and Injuries

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Robert Ehrman, MD

  Wayne SU

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Ehrman, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Volunteer Faculty

Model Details: 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.

Study Record Dates

• First Submitted: December 2, 2019
• First Posted: December 6, 2019
• Study Start: September 1, 2019
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: December 12, 2019

Record last verified: 2019-12

Locations

US (2)