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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up intra-operatively, approximately 4-6 hours
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am 18 years old or older.
Select...
I am having foot surgery and need a nerve block in my ankle for anesthesia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ intra-operatively, approximately 4-6 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~intra-operatively, approximately 4-6 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Onset of sensory Blockage
Secondary outcome measures
Block Failure
Duration of the ankle block
Number of complications
+6 moreTrial 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
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,206 Previous Clinical Trials
3,767,033 Total Patients Enrolled
1 Trials studying Foot Surgery
21 Patients Enrolled for Foot Surgery
Bridget Pulos, MDPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for surgery with spinal or general anesthesia.I am 18 years old or older.I have nerve damage in the limb that will be operated on.I am unable to give consent by myself.I have a blood clotting disorder.I have an infection where I was injected.I am having foot surgery and need a nerve block in my ankle for anesthesia.I have liver or kidney failure.
Research Study Groups:
This trial has the following groups:- Group 1: Mepivacaine group
- Group 2: Bupivacaine group
Awards:
This trial has 5 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this clinical research still have open enrollment?
"From the information posted on clinicaltrials.gov, it is clear that this medical trial has stopped recruiting participants; the original post was published in early January of 2023 and last edited at the end of October 2022. However, there are four other trials actively searching for volunteers at present."
Answered by AI
What potential hazards should be considered when administering drugs from the Mepivacaine family?
"There is a substantial amount of evidence confirming the safety of Mepivacaine, thus it has been rated with a score of 3 on our scale. This Phase 4 trial indicates that this treatment has already been approved for use."
Answered by AI
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