Mepivacaine Versus Bupivacaine Onset Time in Ultrasound-guided Ankle Blocks

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-11

Study Completion Date

2027-03-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Ankle Block Foot Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

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

Study Groups

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Mepivacaine group

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

Group Type ACTIVE_COMPARATOR

Mepivacaine

Intervention Type DRUG

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

Bupivacaine group

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

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

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

Interventions

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Mepivacaine

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

Intervention Type DRUG

Bupivacaine

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No