Mepivacaine vs Bupivacaine for Ankle Block

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Mayo Clinic

Disqualifiers: Allergy to anesthetic, Pregnancy, Hepatic or renal failure, 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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

50 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this research is to determine if both local anesthetics (mepivacaine and bupivacaine) are similar in their onset of sensory block to assess the efficiency of ultrasound-guided ankle blocks in our practice. Currently it is the standard of care to perform ankles blocks with both mepivacaine and bupivacaine. However, given similarity in their safety profile researchers would like to compare if one is non-inferior to the other in terms of onset time of ankle block.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on comparing two local anesthetics for ankle blocks.

What data supports the effectiveness of the drug Bupivacaine for ankle block?

Research shows that Bupivacaine, also known as Marcaine, is effective as a local anesthetic in various medical procedures, providing good pain relief with minimal side effects. It is used in different forms and concentrations for procedures like epidural anesthesia and has been shown to offer effective sensory block and pain relief. ^{1 2 3 4 5}

Is bupivacaine safe for use in humans?

Bupivacaine, also known as Marcaine, is generally considered safe for use in humans when used in recommended doses, with minimal side effects reported in obstetrical analgesia and other applications. Studies have shown that it has a good safety profile, especially when doses are carefully controlled to minimize side effects. ^{1 2 3 6 7}

How does the drug Mepivacaine differ from other treatments for ankle block?

Mepivacaine is unique for its longer and more reliable action in peripheral nerve blocks compared to other local anesthetics like Carticaine, making it a preferred choice for procedures requiring extended anesthesia. ^{1 8 9 10 11}

Research Team

Bridget Pulos, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for adults over 18 needing an ankle block for foot surgery, with a physical status of I-III. It's not for pregnant individuals, those with coagulopathy, liver or kidney failure, neuropathy in the operative limb, planned spinal/general anesthesia, injection site infection, inability to consent or local anesthetic allergy.

Inclusion Criteria

I am 18 years old or older.

Patients who provide informed consent to participate

ASA (American Society of Anesthesiology) Physical Status Classification I - III

Exclusion Criteria

I am scheduled for surgery with spinal or general anesthesia.

I have nerve damage in the limb that will be operated on.

I am unable to give consent by myself.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive an ultrasound-guided peripheral nerve block at the ankle with either mepivacaine or bupivacaine prior to undergoing foot surgery

1 day

1 visit (in-person)

Post-procedural Monitoring

Participants are monitored for pain scores and complications in the post-anesthesia care unit (PACU)

2-4 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment, including block failure, opioid use, and complications

24 hours

Treatment Details

Interventions

• Bupivacaine
• Mepivacaine

Trial Overview The study aims to see if Mepivacaine and Bupivacaine are similar in how quickly they numb the area when used in ultrasound-guided ankle blocks. The goal is to find out which one works faster without compromising safety.

Participant Groups

Group I: Mepivacaine group Active Control 1 Intervention

Subjects will receive an ultrasound-guided peripheral nerve block at the ankle with mepivacaine prior to undergoing foot surgery

Group II: Bupivacaine group Active Control 1 Intervention

Subjects will receive an ultrasound-guided peripheral nerve block at the ankle with bupivacaine prior to undergoing foot surgery

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?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Findings from Research

Bupivacaine with a vasoconstrictor has a shorter onset time for local anesthesia compared to bupivacaine without a vasoconstrictor, but the duration of anesthesia is longer without the vasoconstrictor.

Using bupivacaine without a vasoconstrictor resulted in lower postoperative pain levels and better blood circulation, which is beneficial for the osseointegration of dental implants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical parameters of the local anesthetic effects of bupivacaine applied with and without a vasoconstrictor in oral implantology. Duka, M., Lazić, Z., Stamatović, N., et al.[2019]

Bupivacaine (Marcaine) is effective for epidural analgesia in obstetrics, providing excellent sensory block with minimal impact on motor function and few side effects for both mothers and newborns.

When used at concentrations below 0.5%, and with careful dosing during labor, the risk of side effects and toxicity is low, and significant effects on newborns are rare due to the drug's high protein binding limiting its transfer across the placenta.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The use of Marcaine in obstetrical analgesia]. Seebacher, J., Chareire, F., Galli-Douant, P., et al.[2013]

In a study involving 30 patients, two forms of 0.5% bupivacaine hydrochloride (Anecaine and Marcaine) were compared for epidural anesthesia, revealing differences in how quickly and effectively they provided pain relief.

Anecaine showed a shorter onset of analgesia at the catheter site but a delayed effect in peripheral areas compared to Marcaine, indicating that even the same active ingredient can behave differently based on the manufacturer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A clinical trial of the use of 2 forms of bupivacaine hydrochloride (Anecaine and Marcaine) for epidural anesthesia]. Kozlov, SP., Vashchinskaia, TV., Svetlov, VA.[2013]

References

1. Serbia pubmed.ncbi.nlm.nih.gov

Clinical parameters of the local anesthetic effects of bupivacaine applied with and without a vasoconstrictor in oral implantology. [2019]

2. France pubmed.ncbi.nlm.nih.gov

[The use of Marcaine in obstetrical analgesia]. [2013]

3. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[A clinical trial of the use of 2 forms of bupivacaine hydrochloride (Anecaine and Marcaine) for epidural anesthesia]. [2013]

4. Italy pubmed.ncbi.nlm.nih.gov

[0.75% and 0.5% bupivacaine in peridural lumbar block for surgery on the lower abdomen; a double-blind comparison and myographic study]. [2013]

5. India pubmed.ncbi.nlm.nih.gov

Preventive Effects of Pre- and Intra-operative Marcaine, Lidocaine, and Marcaine Plus Lidocaine on Pain Relief in Lumbar Disc Herination Open Surgery. [2022]

6. Belgium pubmed.ncbi.nlm.nih.gov

Spinal anesthesia: comparison of plain ropivacaine, bupivacaine and levobupivacaine for lower abdominal surgery. [2018]

7. Brazil pubmed.ncbi.nlm.nih.gov

[0.5% enantiomeric excess bupivacaine (S75-R25), 0.5% racemic bupivacaine, and 2%lidocaine for facial nerve block by the O'Brien technique: a comparative study.]. [2019]

8. Germany pubmed.ncbi.nlm.nih.gov

[Comparative studies of the local anaesthetic action of carticaine 1% and mepivacaine 1% (author's transl)]. [2013]

9. Germany pubmed.ncbi.nlm.nih.gov

[Comparison of the effect and serum level of mepivacaine HCL and mepivacaine CO2 in axillary brachial plexus anesthesia]. [2013]

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

Bupivacaine versus L-bupivacaine for labor analgesia via combined spinal-epidural: a randomized, double-blinded study. [2013]

11. Germany pubmed.ncbi.nlm.nih.gov

[Mepivacaine for axillary plexus anesthesia. Comparison of mepivacaine-CO2 and mepivacaine-HCI]. [2013]