Ultrasound Guided Femoral Nerve Block

Phase

N/A

Condition

Osteoporosis

Treatment

morphine

bupivacaine

ultra-sound guide

Clinical Study ID

NCT02381717

2014P000304

Ages 18-101
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Patients over 18 years of age presenting to the ED with radiographically establishedintra-, extracapsular hip fracture, able to consent and participate in the study andwho have moderate to severe pain (numerical pain score >= 31) at the time ofenrollment.

Exclusion

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 needleplacement.
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

Study Design

morphine

August 01, 2015

December 31, 2025

Study 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.

Connect with a study center

Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United States
Site Not Available
St. Vincent's Hospital
Worcester, Massachusetts 01608
United States
Site Not Available
Beth Israel Deaconess Medical Center
Boston 4930956, Massachusetts 6254926 02215
United States
Site Not Available
St. Vincent's Hospital
Worcester 4956184, Massachusetts 6254926 01608
United States
Site Not Available

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