Boston, Massachusetts 02215


Purpose:

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.


Study summary:

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.


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.


NCT ID:

NCT02381717


Primary Contact:

Principal Investigator
Beatrice Hoffmann, MD PhD
Beth Israel Deaconess Medical

Beatrice Hoffmann, MD PhD
Phone: 617-754-2323
Email: bhoffma2@bidmc.harvard.edu


Backup Contact:

Email: erosseto@bidmc.harvard.edu
Elinita Rosseto
Phone: 617-754-2332


Location Contact:

Boston, Massachusetts 02215
United States

Beatrice Hoffmann, MD PhD
Phone: 617-754-2323
Email: bhoffma2@bidmc.harvard.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 19, 2017

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