- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02381717
Ultrasound Guided Femoral Nerve Block
Comparison of Ultrasound Guided Femoral Nerve Blockade and Standard Parenteral Opioid Pain Management Alone in Patients With Hip Fracture in the Emergency Department
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In this proposed protocol the investigators will conduct a prospective, randomized control trial comparing the efficacy of Ultrasound Guided Femoral Nerve Blockade (USFNB) versus the standard of care pain management by parenteral injection of opioid pain medication of patients presenting with hip fracture at the BIDMC ED. We hypothesize that USNFB approach will be non-inferior in achieving pain control (efficacy) and superior in the total dose of opioids (lower amount) as compared to the standard protocol. The enrolled population will be randomized 1:1 using a simple balanced randomization scheme.
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
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Worcester, Massachusetts, United States, 01608
- St. Vincent's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients over 18 years of age presenting to the ED with radiographically established intra-, extracapsular hip fracture, able to consent and participate in the study and who have moderate to severe pain (numerical pain score >= 31) at the time of enrollment.
Exclusion Criteria:
- Patients with a previous history of hypersensitivity to local anesthetics,
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 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)
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Patients randomized to this arm will have the femoral nerve block with the guidance of a bedside ultrasound
Other Names:
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Active Comparator: 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)
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pain intensity reduction
Time Frame: 4 hours after initiation of study proceduure
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Evaluation of pain severity and relief will be assessed utilizing a Visual Analog Scale (VAS)
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4 hours after initiation of study proceduure
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Collaborators and Investigators
Investigators
- Principal Investigator: Beatrice Hoffmann, MD PhD, Beth Israel Deaconess Medical
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Wounds and Injuries
- Leg Injuries
- Fractures, Bone
- Femoral Fractures
- Hip Injuries
- Hip Fractures
- Organic Chemicals
- Heterocyclic Compounds
- Heterocyclic Compounds, Fused-Ring
- Alkaloids
- Polycyclic Aromatic Hydrocarbons
- Polycyclic Compounds
- Anilides
- Amides
- Aniline Compounds
- Amines
- Health Services
- Health Care Facilities Workforce and Services
- Community Health Services
- Behavioral Disciplines and Activities
- Anesthesia and Analgesia
- Heterocyclic Compounds, 4 or More Rings
- Mental Health Services
- Morphinans
- Opiate Alkaloids
- Heterocyclic Compounds, Bridged-Ring
- Phenanthrenes
- Morphine Derivatives
- Bupivacaine
- Morphine
- Counseling
- Analgesia
Other Study ID Numbers
- 2014P000304
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