Comparing ultrasound-guided femoral nerve block to opioid pain management for hip fractures
Comparison of Ultrasound Guided Femoral Nerve Blockade and Standard Parenteral Opioid Pain Management Alone in Patients With Hip Fracture in the Emergency Department
This study is testing whether an ultrasound-guided nerve block can help people with hip fractures manage their pain better and with fewer side effects than regular opioid pain medication.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 101 Years |
| Sex | All |
| Sponsor | Beth Israel Deaconess Medical Center Academic / other |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT02381717 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of Ultrasound Guided Femoral Nerve Blockade (USFNB) compared to standard opioid pain management in patients with hip fractures presenting to the emergency department. It is a prospective, randomized control trial where participants will be randomly assigned to receive either USFNB or parenteral opioids. Pain relief will be measured using a Visual Analog Scale (VAS) over a 4-hour period, and the total opioid dosage will also be assessed. The aim is to determine if USFNB provides equal or better pain control with fewer side effects than traditional opioid therapy.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with confirmed hip fractures and moderate to severe pain.
Not a fit: Patients with a history of hypersensitivity to local anesthetics or signs of infection at the injection site may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved pain management for hip fracture patients while reducing reliance on opioids.
How similar studies have performed: Other studies have shown promising results with ultrasound-guided nerve blocks, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts and 1 other locations
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)
- St. Vincent's Hospital — Worcester, Massachusetts, United States (Completed)
Study contacts
- Principal investigator: Beatrice Hoffmann, MD PhD — Beth Israel Deaconess Medical
- Study coordinator: Beatrice Hoffmann, MD PhD
- Email: bhoffma2@bidmc.harvard.edu
- Phone: 617-754-2323
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.