Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
The investigators will perform a small prospective non-randomized interventional pilot study to assess feasibility of a future full scale RCT to test the 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. The investigators will enroll subjects 2 controls to 1 intervention to ensure the ability to select controls as similar to the intervention population as possible. The study is powered for an alpha of 0.9 and an effect size (standardized difference) of 0.2. The total subjects needed to enroll is 36 with 18 subjects in each arm of the study. However, in an attempt to obtain controls as closely matched to our intervention group as possible 36 controls will be enrolled.
A. Subject Selection
Intervention subjects will be enrolled as a convenience sample when physicians participating in the study are available in the ED. Controls will be enrolled when no study participating physicians are available in the ED. Potential subjects will be selected for enrollment by research team members directly from the trauma bay or from the tracking board when they are identified as having a qualifying fracture. They will be screened for exclusion and inclusion criteria by the research assistants. The goal will be to enroll patients within 2 hours of arrival in the ED.
Inclusion Criteria:
Exclusion Criteria:
Allergy to upivacaine/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
3a. Consent: If the patient qualifies for study inclusion a research assistant will obtain patient written consent to: receive a nerve block placed by a trained physician participating in the study, allow for access of their medical record for purposes of data collection for the study and collect patient contact information for follow up communication related to the study after discharge. The patient will be informed that should they complete all the follow up information as part of this study they will receive a monetary incentive for participation in person at their final follow up, 30 days after the nerve block.
After patients are consented either a supraclavicular brachial plexus block or fascia iliaca nerve block (determined by site of injury) will be performed by an ultrasound trained faculty member, ultrasound fellow or resident who has undergone specific training to perform the blocks included in this study. The research team will be given a list of physicians qualified to perform the selected blocks for this study.
B. Interventions
Prior to administering a nerve block to an enrolled patient a complete neurovascular exam will be performed and documented on a paper form that will be kept in the patient's chart for review by orthopedic surgery and/or trauma surgery if needed while the patient is admitted. Any questionable exam findings will be discussed in conjunction with orthopedic surgery and/or trauma surgery prior to block administration.
C. Subject Follow Up
D. Data Collection and Interpretation
Data on each subject will be collected by research assistants and stored in a secure, de-identified REDCap database/spreadsheet. Data points collected will include: age, sex, fracture type, history of opioid abuse or opioid prescription, history if IV drug use, type of nerve block administered, and location of block placement. At follow up points data will be collected on patient reported pain scores using the VAS scoring system. Self reported opioid use, pill counts and reported healthcare visits for pain from initial injury will be recorded and stored. Data will be collected at follow ups on patient satisfaction using surveys that have Likert scaled questions. Data will be collected directly from the EMR at previously outlined points documenting each subjects opioid prescriptions and opioid use.
A statistician from the Wayne State Research Department will be utilized for data interpretation after collection of data from subjects.
E. Study Timeline
This pilot study will be conducted over a span of 12 months. The initial 6 weeks will be utilized providing study training to the participating research assistants. This time will also be spent providing block training, skills assessments and teaching to participating physicians. The following 8 months will be spent enrolling subjects and collecting data. The remaining 2 months and 2 weeks will be used for data interpretation and creation of a manuscript for submission detailing findings from this study.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care Pain Management | Active Comparator |
| |
| Early Administration of US Guided Nerve Blocks | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Opioids administered for pain control as measured in Morphine Milliequivalents |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robert Ehrman, MD | Contact | 313-745-3330 | rehrman@med.wayne.edu |
| Name | Affiliation | Role |
|---|---|---|
| Robert Ehrman, MD | Wayne SU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Detroit Receiving Hospital | Recruiting | Detroit | Michigan | 48201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30054152 | Background | 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. | |
| 29705075 |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
|
| Early US Guided Nerve Block Administration | Procedure | US-Guided regional anesthesia (fascia illiaca compartment block or brachial plexus block) |
|
Determine if early administration of nerve blocks results in change in MMEs required for pain control compared to standard care. |
| 30-days following injury |
| Sinai Grace Hospital | Recruiting | Detroit | Michigan | 48235 | United States |
|
| 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. |
| 30063596 | 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. |
| 29794282 | 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. |
| 29049117 | 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. |
| 26760086 | 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. |
| 26330019 | 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. |
| 26361135 | 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. |
| 24891581 | 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. |
| 23811426 | 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. |
| 23758305 | 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. |
| 22494596 | 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. |
| 20006206 | 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. |
| 17499669 | 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. |
| 17413915 | 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. |
| 12548273 | 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. |
| 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 |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D009293 | Opioid-Related Disorders |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided