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Ultrasound Guided Femoral Nerve Block

Primary Purpose

Hip Fracture

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ultra-sound guide
bupivacaine
morphine
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fracture focused on measuring ultrasound, bupivacaine, femoral nerve block, pain reduction

Eligibility Criteria

18 Years - 101 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beth Israel Deaconess Medical CenterRecruiting
  • St. Vincent's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ultra-sound guided femoral nerve block

standard of care- IV morphine

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 27, 2015
Last Updated
October 20, 2020
Sponsor
Beth Israel Deaconess Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02381717
Brief Title
Ultrasound Guided Femoral Nerve Block
Official Title
Comparison of Ultrasound Guided Femoral Nerve Blockade and Standard Parenteral Opioid Pain Management Alone in Patients With Hip Fracture in the Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 2015 (undefined)
Primary Completion Date
May 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fracture
Keywords
ultrasound, bupivacaine, femoral nerve block, pain reduction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ultra-sound guided femoral nerve block
Arm Type
Experimental
Arm Description
Patients in this arm will receive a bed-side ultrasound guided femoral nerve block with analgesia 0.5% bupivacaine (2mg/kg)
Arm Title
standard of care- IV morphine
Arm Type
Active Comparator
Arm Description
Patients in this arm will have the femoral nerve block block with no ultrasound for guidance with analgesia (IV morphine)
Intervention Type
Other
Intervention Name(s)
ultra-sound guide
Intervention Description
Patients randomized to this arm will have the femoral nerve block with the guidance of a bedside ultrasound
Intervention Type
Drug
Intervention Name(s)
bupivacaine
Other Intervention Name(s)
femoral nerve block femoral nerve block with analgesia 0.5% bupivacaine (2mg/kg)
Intervention Type
Drug
Intervention Name(s)
morphine
Other Intervention Name(s)
femoral nerve block block with no ultrasound for guidance with analgesia (IV morphine)
Primary Outcome Measure Information:
Title
pain intensity reduction
Description
Evaluation of pain severity and relief will be assessed utilizing a Visual Analog Scale (VAS)
Time Frame
4 hours after initiation of study proceduure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
101 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Beatrice Hoffmann, MD PhD
Phone
617-754-2323
Email
bhoffma2@bidmc.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Elinita Rosseto
Phone
617-754-2332
Email
erosseto@bidmc.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beatrice Hoffmann, MD PhD
Organizational Affiliation
Beth Israel Deaconess Medical
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beatrice Hoffmann, MD PhD
Phone
617-754-2323
Email
bhoffma2@bidmc.harvard.edu
First Name & Middle Initial & Last Name & Degree
Hayes Sharon, RN
Phone
617-754-2334
Email
srhayes@bidmc.harvard.edu
Facility Name
St. Vincent's Hospital
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01608
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sigel Pamela, RN
Phone
508-363-5286
Email
psigel@bidmc.harvard.edu
First Name & Middle Initial & Last Name & Degree
Hardin John, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
12560416
Citation
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.
Results Reference
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PubMed Identifier
21079698
Citation
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.
Results Reference
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PubMed Identifier
17400161
Citation
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.
Results Reference
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PubMed Identifier
12548273
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. doi: 10.1067/mem.2003.51.
Results Reference
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PubMed Identifier
18594262
Citation
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.
Results Reference
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PubMed Identifier
19903026
Citation
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.
Results Reference
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PubMed Identifier
16857561
Citation
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.
Results Reference
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PubMed Identifier
9322469
Citation
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.
Results Reference
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PubMed Identifier
8604855
Citation
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.
Results Reference
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PubMed Identifier
11354213
Citation
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.
Results Reference
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PubMed Identifier
22032803
Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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PubMed Identifier
33238043
Citation
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Results Reference
derived

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Ultrasound Guided Femoral Nerve Block

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