Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2015-08-31
2026-12-31
Brief Summary
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Detailed Description
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Participants will be surveyed six times 6 times on a Visual Analog Scale (VAS)\* on their pain intensity reduction over 4 hours.
Physicians performing the block will be surveyed promptly following the procedure regarding difficulty performing the block and its efficacy.
Specific Aim #1: The investigators hypothesize that in patients presenting to the ED with hip fracture, USFNB will demonstrate equal efficacy in pain relief with fewer side effects when compared to conventional parenteral opioid therapy. The investigators evaluate this hypothesis by monitoring Visual Analogue Scales (VAS) in patients receiving either USGFNB or opioid therapy over the first 4 hours of observation. The side effects will be noted during the same interval of time.
Specific Aim #2: The investigators hypothesize that in patients presenting to the ED with hip fracture, USFNB will reduce the amount of narcotic used to control pain. The investigators will evaluate this by studying narcotic use over the first 4 hours of evaluation.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ultra-sound guided femoral nerve block
Patients in this arm will receive a bed-side ultrasound guided femoral nerve block with analgesia 0.5% bupivacaine (2mg/kg)
ultra-sound guide
Patients randomized to this arm will have the femoral nerve block with the guidance of a bedside ultrasound
bupivacaine
standard of care- IV morphine
Patients in this arm will have the femoral nerve block block with no ultrasound for guidance with analgesia (IV morphine)
morphine
Interventions
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ultra-sound guide
Patients randomized to this arm will have the femoral nerve block with the guidance of a bedside ultrasound
bupivacaine
morphine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients who have signs of a local infection at the site of planned needle placement.
* INR \> 1.4NOAC use within 48 hours
* Prophylactic Low-Molecular Weight Heparin (LMWH) within 12 hours
* Therapeutic LMWH within 24 hours
* Prophylactic Unfractionated Heparin (5000 Units BID or TID) within 6 hours
18 Years
101 Years
ALL
No
Sponsors
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Beth Israel Deaconess Medical Center
OTHER
Responsible Party
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Beatrice Hoffmann
Principal Investigator
Principal Investigators
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Beatrice Hoffmann, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical
Locations
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
St. Vincent's Hospital
Worcester, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Morrison RS, Magaziner J, Gilbert M, Koval KJ, McLaughlin MA, Orosz G, Strauss E, Siu AL. Relationship between pain and opioid analgesics on the development of delirium following hip fracture. J Gerontol A Biol Sci Med Sci. 2003 Jan;58(1):76-81. doi: 10.1093/gerona/58.1.m76.
Christos SC, Chiampas G, Offman R, Rifenburg R. Ultrasound-guided three-in-one nerve block for femur fractures. West J Emerg Med. 2010 Sep;11(4):310-3.
Baker BC, Buckenmaier C, Narine N, Compeggie ME, Brand GJ, Mongan PD. Battlefield anesthesia: advances in patient care and pain management. Anesthesiol Clin. 2007 Mar;25(1):131-45, x. doi: 10.1016/j.anclin.2006.12.003.
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.
Malchow RJ, Black IH. The evolution of pain management in the critically ill trauma patient: Emerging concepts from the global war on terrorism. Crit Care Med. 2008 Jul;36(7 Suppl):S346-57. doi: 10.1097/CCM.0b013e31817e2fc9.
Grabinsky A, Sharar SR. Regional anesthesia for acute traumatic injuries in the emergency room. Expert Rev Neurother. 2009 Nov;9(11):1677-90. doi: 10.1586/ern.09.110.
O'Donnell BD, Mannion S. Ultrasound-guided femoral nerve block, the safest way to proceed? Reg Anesth Pain Med. 2006 Jul-Aug;31(4):387-8. doi: 10.1016/j.rapm.2006.04.007. No abstract available.
Marhofer P, Schrogendorfer K, Koinig H, Kapral S, Weinstabl C, Mayer N. Ultrasonographic guidance improves sensory block and onset time of three-in-one blocks. Anesth Analg. 1997 Oct;85(4):854-7. doi: 10.1097/00000539-199710000-00026.
Todd KH. Clinical versus statistical significance in the assessment of pain relief. Ann Emerg Med. 1996 Apr;27(4):439-41. doi: 10.1016/s0196-0644(96)70226-3. No abstract available.
Kelly AM. The minimum clinically significant difference in visual analogue scale pain score does not differ with severity of pain. Emerg Med J. 2001 May;18(3):205-7. doi: 10.1136/emj.18.3.205.
Platts-Mills TF, Esserman DA, Brown DL, Bortsov AV, Sloane PD, McLean SA. Older US emergency department patients are less likely to receive pain medication than younger patients: results from a national survey. Ann Emerg Med. 2012 Aug;60(2):199-206. doi: 10.1016/j.annemergmed.2011.09.014. Epub 2011 Oct 26.
Bijur PE, Kenny MK, Gallagher EJ. Intravenous morphine at 0.1 mg/kg is not effective for controlling severe acute pain in the majority of patients. Ann Emerg Med. 2005 Oct;46(4):362-7. doi: 10.1016/j.annemergmed.2005.03.010.
Fredrickson MJ, Kilfoyle DH. Neurological complication analysis of 1000 ultrasound guided peripheral nerve blocks for elective orthopaedic surgery: a prospective study. Anaesthesia. 2009 Aug;64(8):836-44. doi: 10.1111/j.1365-2044.2009.05938.x.
Guay J, Kopp S. Peripheral nerve blocks for hip fractures in adults. Cochrane Database Syst Rev. 2020 Nov 25;11(11):CD001159. doi: 10.1002/14651858.CD001159.pub3.
Other Identifiers
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2014P000304
Identifier Type: -
Identifier Source: org_study_id
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