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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for managing hip fracture pain in the emergency room. Researchers aim to determine if an ultrasound-guided nerve block using bupivacaine (a local anesthetic) is as effective as the usual pain treatment with IV morphine. Participants will receive either the ultrasound-guided nerve block or the standard morphine treatment. Suitable candidates for this study include individuals with a confirmed hip fracture experiencing moderate to severe pain. As an unphased trial, this study allows participants to contribute to innovative pain management research that could enhance emergency care practices.

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 prior data suggests that this ultrasound-guided femoral nerve block is safe for hip fracture patients?

Research has shown that using ultrasound to guide femoral nerve blocks is generally safe. A large study found complications in only 0.4% of over 2,700 procedures across various emergency rooms. This equates to only 4 out of every 1,000 patients experiencing issues, with just one major problem reported. Other studies indicate that this method effectively manages pain, especially compared to opioids. Overall, evidence suggests that patients tolerate this treatment well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ultrasound-guided femoral nerve block for hip fractures because it offers a new method of delivering pain relief. Unlike traditional methods that rely solely on intravenous morphine, this approach uses ultrasound to precisely guide the nerve block, potentially leading to more effective pain management and fewer side effects. Bupivacaine, the active ingredient in the nerve block, provides targeted analgesia directly at the source of pain, which could mean faster relief and improved patient comfort. This technique might reduce the need for systemic pain medications, which often come with a host of side effects. By refining the way pain is managed in hip fractures, this method could revolutionize patient care and recovery.

What evidence suggests that this trial's treatments could be effective for hip fractures?

Research has shown that using ultrasound to guide a femoral nerve block can relieve pain from hip fractures more effectively than regular pain medications. In this trial, some participants will receive an ultrasound-guided femoral nerve block with analgesia using 0.5% bupivacaine. Studies have found that this method not only reduces pain but also improves mobility after a hip fracture. The technique uses ultrasound to help doctors precisely target the nerve, enhancing pain relief. Early results suggest that patients experience less pain and may require fewer strong painkillers, such as opioids, with this method. Overall, the ultrasound-guided femoral nerve block appears promising for reducing pain during hip fracture recovery. ^{1 2 4 6 7}

Who Is on the Research Team?

Beatrice Hoffmann, MD PhD

Principal Investigator

Beth Israel Deaconess Medical

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02381717

NCT02381717 | Ultrasound Guided Femoral Nerve Block 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9146076/

Ultrasound-Guided Femoral Nerve Block in Geriatric ... Currently, evidence suggests that femoral nerve block yields superior outcomes to standard care; however, previous studies have used small ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5173407/

Regional Nerve Blocks Improve Pain and Functional ... Regional nerve blocks improve pain and functional outcomes in hip fracture: a randomized controlled trial.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1878124123000783

Nurse-led ultrasound-guided femoral nerve block We conducted an unblinded, randomised controlled trial investigating the effects of ultrasound-guided femoral nerve block in patients with hip fracture.

5. annemergmed.com annemergmed.com/article/S0196-0644(24)00675-9/fulltext

219 Comparison Between Ultrasound-Guided Femoral ... Previous evidence has suggested that the PENG block is superior to the FNB for pain reduction in patients with intracapsular hip fractures.

6. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2826105

Complication Rates After Ultrasonography-Guided Nerve ... In this cohort study of 2742 UGNBs performed across 11 emergency departments, patients experienced a complication rate of 0.4%. One major complication was ...

7. ceemjournal.org ceemjournal.org/m/journal/view.php?doi=10.15441/ceem.23.112

Femoral nerve blocks versus standard pain control for hip ... Femoral nerve blockade is a safe and effective alternative to opioids for pain control in patients with hip fractures.