Trials / Completed
CompletedNCT02381717
Ultrasound Guided Femoral Nerve Block
Comparison of Ultrasound Guided Femoral Nerve Blockade and Standard Parenteral Opioid Pain Management Alone in Patients With Hip Fracture in the Emergency Department
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 44 (actual)
- Sponsor
- Beth Israel Deaconess Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years – 101 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | ultra-sound guide | Patients randomized to this arm will have the femoral nerve block with the guidance of a bedside ultrasound |
| DRUG | bupivacaine | |
| DRUG | morphine |
Timeline
- Start date
- 2015-08-01
- Primary completion
- 2025-05-01
- Completion
- 2025-12-01
- First posted
- 2015-03-06
- Last updated
- 2026-03-03
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02381717. Inclusion in this directory is not an endorsement.