Clinical trial

Comparison of Ultrasound Guided Femoral Nerve Blockade and Standard Parenteral Opioid Pain Management Alone in Patients With Hip Fracture in the Emergency Department

Name

2014P000304

Description

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.

Trial arms

Trial start

2015-08-01

Estimated PCD

2025-05-01

Trial end

2026-12-01

Status

Recruiting

Treatment

ultra-sound guide

Patients randomized to this arm will have the femoral nerve block with the guidance of a bedside ultrasound

Arms:

ultra-sound guided femoral nerve block

bupivacaine

Arms:

ultra-sound guided femoral nerve block

Other names:

femoral nerve block femoral nerve block with analgesia 0.5% bupivacaine (2mg/kg)

morphine

Arms:

standard of care- IV morphine

Other names:

femoral nerve block block with no ultrasound for guidance with analgesia (IV morphine)

Size

Primary endpoint

pain intensity reduction

4 hours after initiation of study proceduure

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

Updated at

2024-04-03

1 organization

2 products

1 indication

Indication

Hip Fracture

Organization

Beth Israel Deaconess Medical Center

Product

bupivacaine

Product

morphine