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Completed

NCT Number: NCT02381717

Ultrasound Guided Femoral Nerve Block

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.

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Key information

Age range

18 year–101 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ultra-sound guide

Other

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

Bupivacaine

Drug

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

Morphine

Drug

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

Primary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2025
Study completion
2025
First posted
Mar 6, 2015
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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