Ultrasound-Guided Nerve Block for Hip Fractures

Overseen By Elinita Rosseto

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Beth Israel Deaconess Medical Center

Must not be taking: NOAC, LMWH, Heparin

Disqualifiers: Hypersensitivity to anesthetics, local infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 4 hours

60 Participants Needed

Trial Summary

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}

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.

Research Team

Beatrice Hoffmann, MD PhD

Principal Investigator

Beth Israel Deaconess Medical

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.

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.

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

Treatment Details

Interventions

• Bupivacaine
• Morphine
• Ultrasound Guided Femoral Nerve Blockade

Trial Overview 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.

Participant Groups

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

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

Findings from Research

In a study of 35 patients with hip fractures, early ultrasound-guided femoral nerve block (FNB) significantly reduced preoperative opioid consumption by 60% compared to standard pain management, indicating its efficacy in pain control.

The use of ultrasound-guided FNB also led to a 40% reduction in opioid-related adverse events, with no reported complications from the FNB procedure, highlighting its safety as a pain management option.

NCBI (Pubmed)

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. Gerlier, C., Mijahed, R., Fels, A., et al.[2023]

In a study involving 100 elderly patients with neck of femur or proximal femoral fractures, both ultrasound-guided femoral nerve block (FNB) and fascia iliaca compartment block (FICB) provided significant pain relief, with mean reductions in pain scores of 2.3 and 2.62, respectively.

There was no significant difference in pain relief between the two techniques, indicating that FNB is not superior to FICB for managing pain in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-guided femoral nerve blocks are not superior to ultrasound-guided fascia iliaca blocks for fractured neck of femur. Cooper, AL., Nagree, Y., Goudie, A., et al.[2020]

Ultrasound-guided three-in-one femoral nerve block (FNB) is an effective pain management technique for elderly patients with femur fractures, offering regional anesthesia to multiple nerves involved in pain sensation.

This method can help reduce the need for opiates, which can cause cardiovascular and respiratory complications in elderly patients, thus improving overall patient safety and comfort during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-guided three-in-one nerve block for femur fractures. Christos, SC., Chiampas, G., Offman, R., et al.[2021]

Patients receiving a single-injection femoral nerve block (FNB) with ultrasound guidance after total knee arthroplasty (TKA) required significantly less morphine (18.7 mg) compared to those who received saline (39.6 mg) in the first 48 hours post-surgery, indicating better pain control.

The FNB group reported significantly lower pain scores at rest and during movement at multiple time points (4, 8, 12, 24, and 48 hours) and had higher patient satisfaction compared to the saline group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-guided single-injection femoral nerve block provides effective analgesia after total knee arthroplasty up to 48 hours. Sahin, L., Korkmaz, HF., Sahin, M., et al.[2018]

In a study involving 77 patients aged 60 and older with hip fractures, ultrasound-guided femoral nerve block (USFNB) significantly reduced pain scores for both intracapsular and extracapsular fractures, demonstrating its efficacy in pain management.

Pain relief was similar for both types of fractures, with no significant differences in pain reduction at 2 and 3 hours post-procedure, indicating that USFNB is an effective option for managing pain in different types of hip fractures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-guided nerve blocks for intracapsular and extracapsular hip fractures. Dickman, E., Pushkar, I., Likourezos, A., et al.[2022]

The study demonstrated that femoral nerve block (F.N.B.) is an effective analgesic technique for femoral shaft fractures, successfully performed by junior staff without any recorded side effects in 27 patients of all ages.

Both 1% Lignocaine with adrenaline and 0.5% Bupivacaine provided effective pain relief, with varying durations of analgesia, indicating that F.N.B. can be a reliable option for managing pain in femoral fractures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Femoral nerve block in the initial management of femoral shaft fractures. McGlone, R., Sadhra, K., Hamer, DW., et al.[2022]

Ultrasound-guided femoral nerve block (UGFNB) not only provides effective pain relief after femur fractures but also allows for the visualization of nearby structures, which can lead to the discovery of other medical conditions.

In this case, the UGFNB revealed an undiagnosed femoral vein thrombosis (DVT), prompting timely intervention with an inferior vena cava (IVC) filter before surgery, highlighting the importance of ultrasound imaging in improving patient management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep venous thrombosis revealed during ultrasound-guided femoral nerve block. Sutin, KM., Schneider, C., Sandhu, NS., et al.[2018]

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]

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]

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

Ultrasound-guided three-in-one nerve block for femur fractures. [2021]

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]

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

Ultrasound-guided nerve blocks for intracapsular and extracapsular hip fractures. [2022]

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

Femoral nerve block in the initial management of femoral shaft fractures. [2022]

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

Deep venous thrombosis revealed during ultrasound-guided femoral nerve block. [2018]