Opioid Use Clinical Trial
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
NCT number | NCT04189523 |
Other study ID # | 022419MP2F |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | September 1, 2019 |
Est. completion date | June 2020 |
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.
Status | Recruiting |
Enrollment | 54 |
Est. completion date | June 2020 |
Est. primary completion date | June 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Detroit Receiving Hospital | Detroit | Michigan |
United States | Sinai Grace Hospital | Detroit | Michigan |
Lead Sponsor | Collaborator |
---|---|
Wayne State University |
United States,
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
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
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. Review. — View Citation
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. — View Citation
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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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
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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. Review. — View Citation
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. — View Citation
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* Note: There are 20 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Opioids administered for pain control as measured in Morphine Milliequivalents | Determine if early administration of peripheral nerve blocks results in change in MMEs required for pain control compared to standard care. | 7-days following injury | |
Secondary | Opioids administered for pain control as measured in Morphine Milliequivalents | Determine if early administration of nerve blocks results in change in MMEs required for pain control compared to standard care. | 30-days following injury |
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