Ultrasound-Guided Nerve Block for Hip Fractures

Recruiting in Palo Alto (17 mi)

Overseen by Beatrice Hoffmann, MD PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Beth Israel Deaconess Medical Center

Must not be taking: NOAC, LMWH, Heparin

Disqualifiers: Hypersensitivity to anesthetics, local infection, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those who have used certain blood thinners like NOACs within 48 hours or LMWH within specific time frames before the procedure.

What data supports the effectiveness of the treatment Ultrasound-Guided Nerve Block for Hip Fractures?

Research shows that ultrasound-guided femoral nerve blocks can effectively manage pain in patients with hip and femur fractures, providing an alternative to opioid medications like morphine. This method is also used successfully for pain relief after knee surgery, indicating its broader effectiveness in managing pain from various orthopedic conditions.

^{1 2 3 4 5}

Is ultrasound-guided femoral nerve block generally safe for humans?

Research indicates that ultrasound-guided femoral nerve block is generally safe, with no recorded side effects in studies involving patients with femoral fractures. It has been effectively used for pain management in various conditions, including hip and femur fractures, without significant safety concerns.

^{1 2 3 4 6}

How is the ultrasound-guided femoral nerve block treatment for hip fractures different from other treatments?

The ultrasound-guided femoral nerve block (FNB) is unique because it provides targeted pain relief by blocking specific nerves in the hip area, potentially reducing the need for systemic opioids like morphine, which can cause complications in elderly patients. This method also allows for the visualization of surrounding structures, which can help identify other issues, such as deep vein thrombosis, that might affect patient management.

^{1 2 3 5 7}

Eligibility Criteria

This trial is for adults over 18 who come to the emergency department with a confirmed hip fracture and have moderate to severe pain. They must be able to give consent and participate in the study.

Inclusion Criteria

I am over 18, have a hip fracture confirmed by X-ray, can consent, and have moderate to severe pain.

Exclusion Criteria

INR > 1.4

I have an infection where they plan to insert the needle.

I haven't taken any blood thinners in the last 48 hours.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either Ultrasound Guided Femoral Nerve Blockade or standard parenteral opioid pain management

4 hours

1 visit (in-person)

Follow-up

Participants are monitored for pain intensity reduction and side effects using Visual Analog Scale (VAS)

4 hours

Participant Groups

The study compares two methods of pain management for hip fractures: Ultrasound Guided Femoral Nerve Blockade (USFNB) using bupivacaine versus standard opioid medication like morphine given through injection.

Group I: ultra-sound guided femoral nerve block Experimental Treatment 2 Interventions

Patients in this arm will receive a bed-side ultrasound guided femoral nerve block with analgesia 0.5% bupivacaine (2mg/kg)

Group II: standard of care- IV morphine Active Control 1 Intervention

Patients in this arm will have the femoral nerve block block with no ultrasound for guidance with analgesia (IV morphine)

Bupivacaine is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Marcaine for:

• Local anesthesia for surgery
• Acute pain management
• Spinal anesthesia

🇪🇺 Approved in European Union as Marcaine for:

• Local anesthesia for surgery
• Acute pain management
• Spinal anesthesia

🇨🇦 Approved in Canada as Sensorcaine for:

• Local anesthesia for surgery
• Acute pain management
• Spinal anesthesia

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Beth Israel Deaconess Medical Center Boston, MA

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center Lead Sponsor

References

1. England pubmed.ncbi.nlm.nih.gov

Effect of early ultrasound-guided femoral nerve block on preoperative opioid consumption in emergency patients with hip fracture: a randomized trial. [2023] Ultrasound-guided femoral nerve block (FNB) could be used as part of a multimodal preoperative pain management for patients with hip fracture. Evidence of the effects of its early implementation in the emergency room as an immediate alternative to intravenous morphine titration is sparse.

2. Australia pubmed.ncbi.nlm.nih.gov

Ultrasound-guided femoral nerve blocks are not superior to ultrasound-guided fascia iliaca blocks for fractured neck of femur. [2020] To determine if an ultrasound-guided femoral nerve block (FNB) is superior to an ultrasound-guided fascia iliaca compartment block (FICB) in providing pain relief to patients with a neck of femur or proximal femoral fracture.

3. United States pubmed.ncbi.nlm.nih.gov

Ultrasound-guided three-in-one nerve block for femur fractures. [2021] Femur fractures typically affect elderly patients with multiple co-morbidities. Pain control can be difficult, requiring intensive nursing and physician care as elderly patients may manifest cardiovascular and respiratory complications from opiate administration. Ultrasound (US)-guided three-in-one (3-in-1) femoral nerve block (FNB) is an option for pain management in patients with femur fractures, as it provides regional anesthesia to the femoral, obturator and lateral cutaneous nerves. Our goal is to provide medical education regarding the use of US-guided 3-in-1FNB as a rapid and easy procedure that may provide optimal patient care in patients with femur fractures.

4. Turkey pubmed.ncbi.nlm.nih.gov

Ultrasound-guided single-injection femoral nerve block provides effective analgesia after total knee arthroplasty up to 48 hours. [2018] The purpose of this study is to evaluate the effects of ultrasound (US) guided single-injection femoral nerve block (FNB) spinal anesthesia on pain control, morphine consumption, adverse effects, and patient satisfaction during the postoperative 48-hour period in patients undergoing total knee arthroplasty (TKA).

5. United States pubmed.ncbi.nlm.nih.gov

Ultrasound-guided nerve blocks for intracapsular and extracapsular hip fractures. [2022] To compare pain relief between patients with intracapsular and extracapsular hip fractures who received an ultrasound-guided femoral nerve block (USFNB).

6. England pubmed.ncbi.nlm.nih.gov

Femoral nerve block in the initial management of femoral shaft fractures. [2022] The aim of this study was to demonstrate that the under-used technique of femoral nerve block (F.N.B.) (Berry, 1977) has excellent analgesic action for femoral shaft fractures when performed by junior staff. It had no recorded side effects and was used in all age groups for fractures at all levels along the femoral shaft. Twenty-seven consecutive patients were studied as they presented in an accident room, all received a femoral nerve block (10 ml 1% Lignocaine with 1:200,000 adrenaline) from unsupervised junior accident and emergency staff instructed in the technique. Each case was subsequently followed up, and both the delay before the onset of analgesia and total duration of analgesia, together with its efficacy, were assessed. A further F.N.B. using a different agent (10 ml 0.5% bupivacaine) was performed and the same parameters were assessed. Both agents gave effective analgesia of varying duration at all levels of fracture site.

7. England pubmed.ncbi.nlm.nih.gov

Deep venous thrombosis revealed during ultrasound-guided femoral nerve block. [2018] Ultrasound imaging used to facilitate performance of a femoral nerve block also affords imaging of adjacent anatomical structures. Following a fracture of the femur, an ultrasound guided femoral nerve block (UGFNB) was performed to provide analgesia; this led to the incidental finding of a previously undiagnosed femoral vein thrombosis (DVT), resulting in a change in patient management before surgery. An inferior vena cava (IVC) filter was placed before intramedullary nailing of the fracture.