Ultrasound Guided Femoral Nerve Block

NCT02381717 | Completed DMC

• 1 other identifier: 2014P000304
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of the study is to evaluate whether pain control achieved by Ultrasound Guided Femoral Nerve Blockade (USFNB) is equal in efficacy to standard pain management practice of parenteral injection of opioid pain medication in patients presenting to the emergency department (ED) with hip fracture.

Conditions

Hip Fracture

Keywords

ultrasound; bupivacaine; femoral nerve block; pain reduction

Outcome Measures

Primary Outcomes (1)

• pain intensity reduction

  Evaluation of pain severity and relief will be assessed utilizing a Visual Analog Scale (VAS)

  4 hours after initiation of study proceduure

Study Arms (2)

ultra-sound guided femoral nerve block

EXPERIMENTAL

Patients in this arm will receive a bed-side ultrasound guided femoral nerve block with analgesia 0.5% bupivacaine (2mg/kg)

Other: ultra-sound guide; Drug: bupivacaine

standard of care- IV morphine

ACTIVE COMPARATOR

Patients in this arm will have the femoral nerve block block with no ultrasound for guidance with analgesia (IV morphine)

Drug: morphine

Interventions

ultra-sound guide OTHER

Patients randomized to this arm will have the femoral nerve block with the guidance of a bedside ultrasound

ultra-sound guided femoral nerve block

bupivacaine DRUG

Also known as: femoral nerve block femoral nerve block with analgesia 0.5% bupivacaine (2mg/kg)

ultra-sound guided femoral nerve block

morphine DRUG

Also known as: femoral nerve block block with no ultrasound for guidance with analgesia (IV morphine)

standard of care- IV morphine

Eligibility Criteria

• Age: 18 Years - 101 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (2)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

St. Vincent's Hospital

Worcester, Massachusetts, 01608, United States

Location

Related Publications (14)

• 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.

  PMID: 12560416 BACKGROUND

• 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.

  PMID: 21079698 BACKGROUND

• 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.

  PMID: 17400161 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

• 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.

  PMID: 18594262 BACKGROUND

• 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.

  PMID: 19903026 BACKGROUND

• 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.

  PMID: 16857561 BACKGROUND

• 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.

  PMID: 9322469 BACKGROUND

• 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.

  PMID: 8604855 BACKGROUND

• 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.

  PMID: 11354213 BACKGROUND

• 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.

  PMID: 22032803 BACKGROUND

• 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.

  PMID: 16187470 BACKGROUND

• 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.

  PMID: 19604186 BACKGROUND

• 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.

  PMID: 33238043 DERIVED

MeSH Terms

Conditions

Hip Fractures

Interventions

Bupivacaine; Analgesia; Morphine; Counseling

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Anesthesia and Analgesia; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Beatrice Hoffmann, MD PhD

  Beth Israel Deaconess Medical

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 27, 2015
• First Posted: March 6, 2015
• Study Start: August 1, 2015
• Primary Completion: May 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 3, 2026

Record last verified: 2026-03

Locations

US (2)