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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two local anesthetics, mepivacaine and bupivacaine, to determine their effectiveness in numbing the ankle during surgery. Researchers seek to find out if one anesthetic works faster than the other when using an ultrasound-guided ankle block, a common practice. The trial seeks participants undergoing foot surgery who require an ankle block for anesthesia. Those with planned foot surgery needing this type of numbing may be suitable candidates. As a Phase 4 trial, this research involves FDA-approved treatments and helps understand their benefits for more patients, offering a chance to contribute to valuable insights.

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 is the safety track record for these treatments?

Research shows that mepivacaine and bupivacaine are both safe for use in nerve blocks. Studies have found short-term complications in about 10.1% of cases and long-term complications in about 4.3% of cases. Although some risks exist, most people handle these treatments well.

Both mepivacaine and bupivacaine are commonly used for ankle blocks, which numb the ankle area before surgery. Current research aims to determine if one drug works faster than the other without increasing risks. Since both drugs are already used for these procedures, they have a proven track record of safety and effectiveness for most patients. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the treatments Mepivacaine and Bupivacaine for ankle blocks because of their unique properties in pain management during foot surgery. Mepivacaine is known for its rapid onset and shorter duration, making it ideal for shorter procedures or when quick recovery is desired. In contrast, Bupivacaine provides longer-lasting pain relief, which can be beneficial for extended post-operative comfort. These treatments offer tailored options depending on the surgical needs and recovery goals, providing flexibility compared to the standard of care.

What is the effectiveness track record for mepivacaine and bupivacaine in ankle blocks?

This trial will compare the effectiveness of mepivacaine and bupivacaine for pain relief during foot surgeries using an ankle block. Research has shown that both mepivacaine, administered to participants in one arm of this trial, and bupivacaine, given to participants in another arm, are effective for pain relief. Specifically, studies have found that mepivacaine reduces pain during and after surgery with few complications. Bupivacaine, however, is known for reducing the need for pain medication after surgery, benefiting those seeking better pain management. Both drugs are generally safe. The trial aims to determine if one drug blocks pain faster and if they are equally effective in ankle blocks. ^{6 7 8 9 10}

Who Is on the Research Team?

Bridget Pulos, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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

Patients who provide informed consent to participate

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

I am having foot surgery and need a nerve block in my ankle for anesthesia.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40916868/

Efficacy of Liposomal Bupivacaine in Ultrasound-Guided ... Conclusion: US-guided peripheral nerve blocks using liposomal bupivacaine were associated with reduced postoperative opioid consumption and ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06995352

Study Details | NCT06995352 | Liposomal Bupivacaine ... The ultimate objective of the proposed research study is to determine if liposomal bupivacaine in a peripheral nerve block is at least non-inferior to a ...

3. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/10711007251359634

Efficacy of Liposomal Bupivacaine in Ultrasound-Guided ... Conclusion: US-guided peripheral nerve blocks using liposomal bupivacaine were associated with reduced postoperative opioid consumption and ...

4. mdpi.com mdpi.com/2077-0383/13/24/7586

Admixture of Liposomal Bupivacaine and ... Liposomal bupivacaine/bupivacaine hydrochloride PNBs were used successfully in adolescents undergoing a variety of orthopedic surgeries.

5. europeanreview.org europeanreview.org/wp/wp-content/uploads/471-484.pdf

Efficacy of regional anesthesia using ankle block in ... Regional anesthesia has several advantages, including effective control of postoperative pain, reduction in pain scores, decreased use of sed- atives and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11808031/

Experimental implementation of the peripheral nerve block ... Peripheral nerve block (PNB) is commonly used, but there is a lack of data on its effectiveness and safety in the clinic.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05425979

Mepivacaine Versus Bupivacaine Onset Time in ... 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.

8. sciencedirect.com sciencedirect.com/science/article/pii/S1268773124000432?dgcid=rss_sd_all

A systematic review with meta-analysis and trial sequential ... Ankle block may increase the duration of analgesia when compared with no intervention/sham block (MD 431 min; 96.7% CI 208 to 654), but the evidence was very ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7450881/

Regional Nerve Block Complication Analysis Following ... The overall short-term complication rate was 10.1% and the long-term complication rate was 4.3%, with a total of 855 blocks given.

10. accp1.onlinelibrary.wiley.com accp1.onlinelibrary.wiley.com/doi/full/10.1002/jcph.6159

A Phase I Study of the Pharmacokinetics, Pharmacodynamics ... This trial assessed the pharmacokinetics, pharmacodynamics, and safety of liposomal bupivacaine given via ultrasound-guided popliteal sciatic nerve block.