Mepivacaine Versus Bupivacaine Onset Time in Ultrasound-guided Ankle Blocks

Phase 4Enrolling By InvitationNCT05425979

Mayo Clinic50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Ankle Block Foot Surgery

Interventions

MepivacaineDRUG

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

BupivacaineDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Onset of sensory Blockage

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

Time frame: 20 minutes

Secondary Outcomes

Block Failure

Number of subjects to experience block failure as defined as opioid administration operatively and /or conversion to general anesthesia

Time frame: 20 minutes

Pain Scores

Pain scores in post-anesthesia care unit (PACU) will be obtained using the numerical rating scale (0-10 point scale with 0 representing no pain and 10 representing the worst possible pain)

Time frame: Post-procedural, approximately 2-4 hours

Total opioid received intra-operatively

Total amount of opioid received intra-operatively

Time frame: Intra-operatively, approximately 4-6 hours

Time to first opioid use

Time measured in minutes to the first opioid use

Time frame: 24 hours

Number of complications

Total number of procedural complications

Time frame: 24 hour

Total anesthesia-related time

Measured in minutes, defined as performance time plus onset time of local anesthesia

Time frame: 20 minutes

Overall Benefit of Analgesia Score (OBAS)

Seven questions to access pain intensity, adverse effects and satisfaction with treatment. Possible score range from 0 to 24, with higher scores indicating worse outcome

Data from ClinicalTrials.gov

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