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Local Anesthetic

Mepivacaine vs Bupivacaine for Ankle Block

Phase 4
Waitlist Available
Led By Bridget Pulos, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age greater than or equal to 18 years old
Patients undergoing foot surgery who require a peripheral nerve block of the ankle as primary anesthesia
Must not have
Planned spinal anesthetic or general anesthesia
Preexisting neuropathy in operative limb
Timeline
Screening 3 weeks
Treatment Varies
Follow Up intra-operatively, approximately 4-6 hours
Awards & highlights
Approved for 10 Other Conditions
All Individual Drugs Already Approved
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial will help determine if mepivacaine or bupivacaine is better for ankle blocks in terms of onset time of the sensory block.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Both Mepivacaine and Bupivacaine can cause side effects like nerve damage at the injection site, allergic reactions including itching or rash, low blood pressure (hypotension), confusion or dizziness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am having foot surgery and need a nerve block in my ankle for anesthesia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am scheduled for surgery with spinal or general anesthesia.
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I have nerve damage in the limb that will be operated on.
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I am unable to give consent by myself.
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I have a blood clotting disorder.
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I have an infection where I was injected.
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I have liver or kidney failure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~intra-operatively, approximately 4-6 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and intra-operatively, approximately 4-6 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Onset of sensory Blockage
Secondary study objectives
Block Failure
Duration of the ankle block
Number of complications
+6 more

Awards & Highlights

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Group I: Mepivacaine groupActive Control1 Intervention
Subjects will receive an ultrasound-guided peripheral nerve block at the ankle with mepivacaine prior to undergoing foot surgery
Group II: Bupivacaine groupActive Control1 Intervention
Subjects will receive an ultrasound-guided peripheral nerve block at the ankle with bupivacaine prior to undergoing foot surgery

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,353 Previous Clinical Trials
3,060,973 Total Patients Enrolled
1 Trials studying Foot Surgery
21 Patients Enrolled for Foot Surgery
Bridget Pulos, MDPrincipal InvestigatorMayo Clinic

Media Library

Bupivacaine (Local Anesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT05425979 — Phase 4
Foot Surgery Research Study Groups: Mepivacaine group, Bupivacaine group
Foot Surgery Clinical Trial 2023: Bupivacaine Highlights & Side Effects. Trial Name: NCT05425979 — Phase 4
Bupivacaine (Local Anesthetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05425979 — Phase 4
~20 spots leftby Jul 2025
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