Mepivacaine Versus Bupivacaine Onset Time in Ultrasound-guided Ankle Blocks

NCT05425979 | Enrolling By Invitation Phase 4 FDA Drug

• 1 other identifier: 22-000140
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ankle Block; Foot Surgery

Keywords

Ultrasound-Guided Ankle Block; Regional anesthesia; Local anesthesia

Outcome Measures

Primary Outcomes (1)

• Onset of sensory Blockage

  Time in minutes for successful surgical sensory blockade following the ankle block

  20 minutes

Secondary Outcomes (9)

• Block Failure

  20 minutes

• Pain Scores

  Post-procedural, approximately 2-4 hours

• Total opioid received intra-operatively

  Intra-operatively, approximately 4-6 hours

• Time to first opioid use

  24 hours

• Number of complications

  24 hour

Study Arms (2)

Mepivacaine group

ACTIVE COMPARATOR

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

Drug: Mepivacaine

Bupivacaine group

ACTIVE COMPARATOR

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

Drug: Bupivacaine

Interventions

Mepivacaine DRUG

Up to two 30 ml vials of mepivacaine 1.5% via ultrasound-guided nerve blockade of the tibial and deep peroneal nerves

Mepivacaine group

Bupivacaine DRUG

Up to two 30 ml vials of bupivacaine 0.5% via ultrasound-guided nerve blockade of the tibial and deep peroneal nerves

Bupivacaine group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than or equal to 18 years old.
• Patients who provide informed consent to participate.
• Patients undergoing foot surgery who require a peripheral nerve block of the ankle as primary anesthesia.
• ASA (American Society of Anesthesiology) Physical Status Classification I - III.

You may not qualify if:

• Inability to consent.
• Allergy to local anesthetic.
• Infection at site of injection.
• Pregnancy.
• Coagulopathy.
• Hepatic or renal failure.
• Preexisting neuropathy in operative limb.
• Planned spinal anesthetic or general anesthesia.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Mepivacaine; Bupivacaine

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Bridget Pulos, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants, the anesthesiologist performing the block and assessing the block efficacy over time will all be masked as to which local anesthetic is being used
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 16, 2022
• First Posted: June 21, 2022
• Study Start: March 11, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)