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

36 Participants Needed

Trial Summary

What is the purpose of this trial?

Surgery performed with nerve blocks and sedation may be safer and provide better pain control compared to general anesthesia and opioid therapy in high-risk patient populations such as elderly and troubled with peripheral vascular disease, diabetes, hypertension, coronary artery disease, and chronic obstructive pulmonary disease (COPD).

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 data supports the effectiveness of this treatment for amputations?

Research shows that using peripheral nerve blocks, which involve numbing specific nerves to reduce pain, can be an effective alternative to general anesthesia for lower limb amputations. These blocks can help control pain after surgery and may offer benefits over traditional methods, especially in high-risk patients. ^{1 2 3 4 5}

Is peripheral nerve block generally safe for humans?

Peripheral nerve blocks are generally considered safe for humans, but there are risks such as local nerve damage and systemic toxicity (harmful effects on the body from the anesthetic). These risks can be minimized with careful technique and understanding of the procedure. ^{6 7 8 9 10}

How is the treatment of peripheral nerve blocks unique for amputations?

Peripheral nerve blocks are unique for amputations because they provide targeted pain relief by numbing specific nerves, which can be especially beneficial for high-risk patients who may not tolerate general anesthesia well. This approach allows patients to remain awake and maintain stable vital signs during surgery, reducing the risk of complications. ^{1 2 11 12 13}

Research Team

José R Soberón, MD

Principal Investigator

Malcom Randall VA Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Turkey pubmed.ncbi.nlm.nih.gov

The use of ultrasound guided combined peripheral nerve blocks in a high-risk patient: A case report. [2021]

2. Ghana pubmed.ncbi.nlm.nih.gov

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

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

Local and regional block in postoperative pain control. [2019]

4. Spain pubmed.ncbi.nlm.nih.gov

[Peripheral nerve block for surgical anesthesia and postoperative analgesia of the legs]. [2009]

5. England 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. [2022]

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

Regional Anesthesia for Orthobiologic Procedures. [2022]

7. France pubmed.ncbi.nlm.nih.gov

[Optimal use of peripheral nerve blocks]. [2013]

8. Brazil pubmed.ncbi.nlm.nih.gov

Identification and economic burden of main adverse events of nerve injuries caused by regional anesthesia: a systematic review. [2023]

9. England 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. [2022]

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

Novel Regional Anesthesia for Outpatient Surgery. [2020]

11. Netherlands pubmed.ncbi.nlm.nih.gov

A survey of emergency medicine and orthopaedic physicians' knowledge, attitude, and practice towards the use of peripheral nerve blocks. [2022]

12. England pubmed.ncbi.nlm.nih.gov

The successful use of peripheral nerve blocks for femoral amputation. [2022]

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

Lower extremity nerve blocks. [2019]