Mepivacaine vs Bupivacaine for Ankle Block

Recruiting in Palo Alto (17 mi)

Overseen by Bridget Pulos, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Mayo Clinic

No Placebo Group

Prior Safety Data

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.

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.

Participant Groups

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.

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Mayo Clinic in Rochester Rochester, MN

Who Is Running the Clinical Trial?

Mayo Clinic Lead Sponsor

References