Ultrasound Guided Femoral Nerve Block
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|ClinicalTrials.gov Identifier: NCT02381717|
Recruitment Status : Recruiting
First Posted : March 6, 2015
Last Update Posted : January 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Hip Fracture||Other: ultra-sound guide Drug: bupivacaine Drug: morphine||Not Applicable|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 :||May 2021|
|Estimated Study Completion Date :||December 2021|
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
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)
Other Name: femoral nerve block block with no ultrasound for guidance with analgesia (IV morphine)
- 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)
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
|Contact: Beatrice Hoffmann, MD PhDfirstname.lastname@example.org|
|Contact: Elinita Rossetoemail@example.com|
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Beatrice Hoffmann, MD PhD 617-754-2323 firstname.lastname@example.org|
|Contact: Hayes Sharon, RN 617-754-2334 email@example.com|
|St. Vincent's Hospital||Not yet recruiting|
|Worcester, Massachusetts, United States, 01608|
|Contact: Sigel Pamela, RN 508-363-5286 firstname.lastname@example.org|
|Principal Investigator: Hardin John, MD|
|Principal Investigator:||Beatrice Hoffmann, MD PhD||Beth Israel Deaconess Medical|