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Ultrasound Guided Femoral Nerve Block

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ClinicalTrials.gov Identifier: NCT02381717
Recruitment Status : Recruiting
First Posted : March 6, 2015
Last Update Posted : October 5, 2018
Sponsor:
Information provided by (Responsible Party):
Beatrice Hoffmann, Beth Israel Deaconess Medical Center

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.

Condition or disease Intervention/treatment Phase
Hip Fracture Other: ultra-sound guide Drug: bupivacaine Drug: morphine Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : August 2015
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019


Arm Intervention/treatment
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)
Other: ultra-sound guide
Patients randomized to this arm will have the femoral nerve block with the guidance of a bedside ultrasound

Drug: bupivacaine
Other Name: femoral nerve block femoral nerve block with analgesia 0.5% bupivacaine (2mg/kg)

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)
Drug: morphine
Other Name: femoral nerve block block with no ultrasound for guidance with analgesia (IV morphine)




Primary Outcome Measures :
  1. pain intensity reduction [ Time Frame: 4 hours after initiation of study proceduure ]
    Evaluation of pain severity and relief will be assessed utilizing a Visual Analog Scale (VAS)



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Ages Eligible for Study:   18 Years to 101 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02381717


Contacts
Contact: Beatrice Hoffmann, MD PhD 617-754-2323 bhoffma2@bidmc.harvard.edu
Contact: Elinita Rosseto 617-754-2332 erosseto@bidmc.harvard.edu

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Beatrice Hoffmann, MD PhD    617-754-2323    bhoffma2@bidmc.harvard.edu   
Contact: Nathan Shapiro, MD    617-754-2343    nshapiro@bidmc.harvard.edu   
St. Vincent's Hospital Not yet recruiting
Worcester, Massachusetts, United States, 01608
Contact: Sigel Pamela, RN    508-363-5286    psigel@bidmc.harvard.edu   
Principal Investigator: Hardin John, MD         
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Beatrice Hoffmann, MD PhD Beth Israel Deaconess Medical

Publications:

Responsible Party: Beatrice Hoffmann, Principal Investigator, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT02381717     History of Changes
Other Study ID Numbers: 2014P000304
First Posted: March 6, 2015    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: October 2018

Keywords provided by Beatrice Hoffmann, Beth Israel Deaconess Medical Center:
ultrasound
bupivacaine
femoral nerve block
pain reduction

Additional relevant MeSH terms:
Hip Fractures
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Hip Injuries
Leg Injuries
Bupivacaine
Morphine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics