Mepivacaine Versus Bupivacaine Onset Time in Ultrasound-guided Ankle Blocks

Onset of Sensory Blockade in Ultrasound-Guided Ankle Block With Mepivacaine Versus Bupivacaine: A Randomized Non-Inferiority Clinical Trial

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 Overview

• Status: Enrolling by invitation
• Conditions: Ankle Block; Foot Surgery
• Intervention / Treatment: Drug: Mepivacaine; Drug: Bupivacaine

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Mepivacaine group; Subjects will receive an ultrasound-guided peripheral nerve block at the ankle with mepivacaine prior to undergoing foot surgery	Drug: Mepivacaine; Up to two 30 ml vials of mepivacaine 1.5% via ultrasound-guided nerve blockade of the tibial and deep peroneal nerves
Active Comparator: Bupivacaine group; Subjects will receive an ultrasound-guided peripheral nerve block at the ankle with bupivacaine prior to undergoing foot surgery	Drug: Bupivacaine; Up to two 30 ml vials of bupivacaine 0.5% via ultrasound-guided nerve blockade of the tibial and deep peroneal nerves

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Onset of sensory Blockage	Time in minutes for successful surgical sensory blockade following the ankle block	20 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Block Failure	Number of subjects to experience block failure as defined as opioid administration operatively and /or conversion to general anesthesia	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)	Post-procedural, approximately 2-4 hours
Total opioid received intra-operatively	Total amount of opioid received intra-operatively	Intra-operatively, approximately 4-6 hours
Time to first opioid use	Time measured in minutes to the first opioid use	24 hours
Number of complications	Total number of procedural complications	24 hour
Total anesthesia-related time	Measured in minutes, defined as performance time plus onset time of local anesthesia	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	24 hours after discharge
Total opioid use after discharge	Total amount of opioids used used for pain control after discharge	24 hours after discharge
Duration of the ankle block	Length of time measured in minutes the patient to felt until the ankle block completely wore off	24 hours after discharge

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Bridget Pulos, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2024
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: June 16, 2022
• First Submitted That Met QC Criteria: June 16, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Local anesthesia; Ultrasound-Guided Ankle Block; Regional anesthesia
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine; Mepivacaine
• Other Study ID Numbers: 22-000140

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No