Peripheral Nerve Blocks for Amputations

Overseen By Amy M. Gunnett, RN, CCRC

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Florida

Must not be taking: Opioids

Disqualifiers: Pregnancy, Severe hepatic impairment, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether nerve blocks with sedation offer safer and better pain control than general anesthesia and opioids for leg amputations. It targets individuals with conditions such as diabetes, high blood pressure, or lung disease, who face higher surgical risks. The trial employs a technique called Peripheral Nerve Block, which numbs specific nerves around the leg to enhance comfort during surgery. Suitable candidates are those requiring an above-the-knee amputation and able to consent to participation. As a Phase 4 trial, this research involves an FDA-approved treatment and aims to understand its benefits for more patients.

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 people who use opioids regularly. If you are on opioids, you may need to stop them to participate.

What is the safety track record for these treatments?

Research has shown that peripheral nerve blocks (PNB) are generally safe and effective for patients undergoing above-the-knee amputations. Studies indicate that PNB provides reliable pain relief for high-risk patients, such as those with diabetes, high blood pressure, and heart disease.

One study found that PNB facilitated smoother surgeries and maintained patient stability during procedures. Another study noted that combining PNB with other calming methods reduced the need for strong sedatives, benefiting patients with complex medical histories.

Although information on long-term safety is limited, these findings suggest that PNB offers a promising option for safer and more effective pain control during surgeries like amputations. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about peripheral nerve blocks for amputations because they offer a targeted approach to anesthesia, which can mean less pain and fewer side effects compared to general anesthesia. Unlike traditional methods that affect the whole body, this technique specifically numbs the nerves in the leg with the help of ultrasound guidance. This precision reduces the need for high doses of sedatives, potentially leading to a quicker recovery and fewer complications. Additionally, the use of single-injection nerve blocks could improve pain management during and after surgery, enhancing the overall patient experience.

What evidence suggests that peripheral nerve blocks might be an effective treatment for amputations?

Research shows that peripheral nerve blocks (PNB), which participants in this trial will receive, effectively numb the area during above-knee amputations, especially for high-risk patients. Studies indicate that PNB can control pain and reduce the need for strong sedatives. In these studies, patients remained stable during surgery and experienced less blood loss compared to traditional methods. By using ultrasound to guide the procedure, PNB also manages pain immediately after surgery. Overall, PNB offers a promising option for safer surgeries with better pain control, particularly for patients with conditions like diabetes and heart disease. ^{1 2 3 6 7}

Who Is on the Research Team?

José R Soberón, MD

Principal Investigator

Malcom Randall VA Medical Center

Are You a Good Fit for This Trial?

This trial is for patients needing above-the-knee amputations who can understand and agree to the study. It's not for those with chronic opioid use, severe liver issues, a BMI over 35, sensorimotor deficits, or true allergies to local anesthetics or sedatives.

Inclusion Criteria

I am having an amputation above my knee.

Ability to understand and provide informed consent

Exclusion Criteria

My BMI is 35 or higher.

I have severe liver problems.

True allergy, not sensitivity, to local anesthetics

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive peripheral nerve blocks and intravenous sedatives for above-the-knee amputations

1 day

1 visit (in-person)

Immediate Post-operative Monitoring

Participants are monitored for pain scores and satisfaction within 48 hours post procedure

2 days

1 visit (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness, including 30-day mortality assessment

30 days

What Are the Treatments Tested in This Trial?

Interventions

• Intravenous Sedatives
• Lateral Femoral Cutaneous Nerve Blocks
• Obturator Nerve Blocks
• Peripheral Nerve Block

Trial Overview

The study tests if using nerve blocks and sedatives during surgery offers better safety and pain control than general anesthesia in patients with conditions like diabetes, high blood pressure, heart disease, COPD.

How Is the Trial Designed?

Group I: Peripheral nerve block Experimental Treatment 4 Interventions

Prospectively evaluate peripheral nerve blocks as a primary anesthetic in the setting of above-the-knee amputations. All enrollees will be administered Intravenous sedatives using propofol or dexmedetomidine and have ultrasound-guided femoral and sciatic nerve blocks placed per current practice at research site. Single-injection obturator nerve blocks and lateral femoral cutaneous nerve blocks will also be performed.

Peripheral Nerve Block is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Peripheral Nerve Block for:

• Pain control after fracture surgery
• Postoperative pain management
• Chronic pain management

Approved in United States as Peripheral Nerve Block for:

• Pain control after fracture surgery
• Postoperative pain management
• Chronic pain management
• Acute pain management

Approved in Canada as Peripheral Nerve Block for:

• Pain control after fracture surgery
• Postoperative pain management
• Chronic pain management

Approved in Japan as Peripheral Nerve Block for:

• Pain control after fracture surgery
• Postoperative pain management

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

US Department of Veterans Affairs

Collaborator

Trials

881

Recruited

502,000+

Published Research Related to This Trial

Recent studies highlight the growing use of peripheral nerve blocks for lower limb surgery, which offer prolonged pain relief and high patient satisfaction with minimal side effects.

Advancements in imaging techniques, such as ultrasound, have enhanced the effectiveness and safety of these nerve blocks, making them a preferred option over central nerve blocks, especially in patients on anticoagulants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lower extremity nerve blocks. Taboada, M., Atanassoff, PG.[2019]

Combined peripheral nerve blocks can effectively serve as an alternative anesthetic technique for lower limb amputations, particularly in high-risk patients.

The specific combination of nerve blocks used for above-the-knee amputation includes a sciatic nerve block via an anterior approach, a femoral nerve block, and a lateral femoral cutaneous nerve block, tailored to the patient's clinical condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of ultrasound guided combined peripheral nerve blocks in a high-risk patient: A case report. Kavaklı, AS., Kavrut Öztürk, N., Arslan, Ü., et al.[2021]

Peripheral nerve blocks are an effective anaesthetic technique for lower limb amputations, with 70% of cases reporting good anaesthesia during surgery.

Patients experienced significant postoperative pain relief lasting between 5 to 30 hours, while maintaining cardiovascular stability throughout the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A preliminary report on the use of peripheral nerve blocks for lower limb amputations. Baddoo, H.[2022]

A study involving 64 healthcare professionals at Black Lion Hospital revealed that while there is a strong belief in the importance of peripheral nerve blocks for pain management, nearly half (48%) do not perform them regularly due to a lack of skills and training.

The study found a significant link between formal training in peripheral nerve blocks and the frequency of their use, suggesting that improving training could enhance their application in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A survey of emergency medicine and orthopaedic physicians' knowledge, attitude, and practice towards the use of peripheral nerve blocks. Zewdie, A., Debebe, F., Azazh, A., et al.[2022]

Peripheral nerve blocks are becoming more popular than general anesthesia due to their advantages, but they still carry risks such as overdose and potential nerve damage.

Techniques involving nerve stimulators, anatomical landmarks, and careful selection of needles and anesthetic solutions can enhance the success of these blocks while minimizing risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Optimal use of peripheral nerve blocks]. Bruelle, P., Mangin, R., Lalourcey, L., et al.[2013]

The study analyzed 21 articles and found that the overall incidence of adverse events associated with Peripheral Nerve Blocks (PNB) is relatively low at 137 per 10,000 patients, based on data from 424,169 patients.

Despite the low incidence of complications, the associated healthcare costs are significant, with median claims reaching $39,524 in the U.S. and £22,750 in the U.K., highlighting the financial impact of these adverse events on healthcare systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification and economic burden of main adverse events of nerve injuries caused by regional anesthesia: a systematic review. Calciolari, S., González-Ortiz, LG., Mongelli, F., et al.[2023]

Peripheral nerve blocks (PNB) for the lower limb provide significant advantages over traditional neuroaxial blockades and general anesthesia, yet their adoption remains limited due to factors like inadequate training and unfamiliarity among medical professionals.

Recent publications indicate a growing interest in lower limb PNBs for surgical procedures and postoperative pain management, highlighting the need for better education on their benefits and techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Peripheral nerve block for surgical anesthesia and postoperative analgesia of the legs]. Taboada Muñiz, M., Rodríguez, J., Alvarez Escudero, J., et al.[2009]

In a study of 11,796 patients undergoing lower extremity amputation, there was no significant difference in 30-day mortality or major complications between those who received peripheral nerve block (PNB) and those who received general anesthesia (GA).

However, patients who received PNB had a significantly lower risk of experiencing postoperative delirium compared to those who received GA, suggesting that PNB may be a safer option in this regard.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing outcomes after peripheral nerve block versus general anesthesia for lower extremity amputation: a nationwide exploratory retrospective cohort study in Japan. Abe, H., Sumitani, M., Matsui, H., et al.[2022]

Peripheral nerve blocks (PNB) can effectively reduce procedural pain and avoid harmful effects of local anesthetics on target tissues, enhancing patient comfort during procedures.

The risks associated with PNBs, such as local nerve damage and systemic toxicity, can be minimized through careful injection techniques and a thorough understanding of the procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regional Anesthesia for Orthobiologic Procedures. Khadavi, M., Rehor, D., Roney, A., et al.[2022]

In a study involving 6950 patients who received peripheral nerve blocks, serious complications were rare, with only 0.5% requiring neurologic assessment and an incidence of nerve injury at 0.4 per 1000 blocks.

The incidence of systemic local anesthetic toxicity was also low at 0.98 per 1000 blocks, suggesting that peripheral nerve blockade is a safe procedure with minimal risk of severe complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary results of the Australasian Regional Anaesthesia Collaboration: a prospective audit of more than 7000 peripheral nerve and plexus blocks for neurologic and other complications. Barrington, MJ., Watts, SA., Gledhill, SR., et al.[2022]

In a case report involving four patients with severe cardiac insufficiency, peripheral nerve blocks were successfully used as the sole anesthetic for above-knee amputation, demonstrating safety and efficacy in high-risk surgical settings.

The patients remained hemodynamically stable and were able to breathe spontaneously during the procedure, suggesting that peripheral nerve blocks can significantly reduce perioperative risks for patients with cardiac issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The successful use of peripheral nerve blocks for femoral amputation. Bech, B., Melchiors, J., Børglum, J., et al.[2022]

Peripheral nerve blocks are effective and safe for pain management during outpatient surgeries, with new ultrasound-guided techniques showing lower risks of complications.

Novel motor-sparing and phrenic-sparing nerve blocks are particularly beneficial for ambulatory procedures, emphasizing the need for careful patient selection and follow-up to ensure safety after discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel Regional Anesthesia for Outpatient Surgery. Li, J., Lam, D., King, H., et al.[2020]

Local and regional nerve blocks are effective for managing postoperative pain, especially in trunk surgeries, providing a good alternative to epidural analgesia.

The rising use of low molecular weight heparin has led to an increased preference for peripheral nerve blocks in patients undergoing lower limb surgeries, enhancing pain control while minimizing complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Local and regional block in postoperative pain control. Peng, PW., Chan, VW.[2019]

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We developed a simple technique for AKA under nerve block and local anesthesia, which is quick and associated with little blood loss compared with conventional ...

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Study Details | NCT06964347 | Combined Local Anesthetic ...

This multi-site clinical trial aims to assess the efficacy and safety of combining peripheral nerve stimulation with local anesthetic nerve ...