Clinical trial NCT02381717: Ultrasound Guided Femoral Nerve Block
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 type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hip Fracture
Keywords: ultrasound
bupivacaine
femoral nerve block
pain reduction
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2015-03-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 101
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: pain intensity reduction
timeFrame: 4 hours after initiation of study proceduure
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: St. Vincent's Hospital
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical
name: Beatrice Hoffmann, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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