Mepivacaine group for Foot Surgery

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Mayo Clinic in Rochester, Rochester, MN
Foot Surgery+1 More
Mepivacaine - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Foot Surgery
  • Ankle Block

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: Intra-operatively, approximately 4-6 hours

20 minutes
Block Failure
Onset of sensory Blockage
Total anesthesia-related time
24 hour
Number of complications
24 hours
Time to first opioid use
24 hours after discharge
Duration of the ankle block
Overall Benefit of Analgesia Score (OBAS)
Total opioid use after discharge
Intra-operatively, approximately 4-6 hours
Total opioid received intra-operatively
Post-procedural, approximately 2-4 hours
Pain Scores

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Mepivacaine group
1 of 2
Bupivacaine group
1 of 2
Active Control

50 Total Participants · 2 Treatment Groups

Primary Treatment: Mepivacaine group · No Placebo Group · Phase 4

Mepivacaine group
Drug
ActiveComparator Group · 1 Intervention: Mepivacaine · Intervention Types: Drug
Bupivacaine group
Drug
ActiveComparator Group · 1 Intervention: Bupivacaine · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: intra-operatively, approximately 4-6 hours

Trial Background

Bridget P. Pulos, Principal Investigator
Principal Investigator
Mayo Clinic
Closest Location: Mayo Clinic in Rochester · Rochester, MN
Photo of Rochester  1Photo of Rochester  2Photo of Rochester  3
2021First Recorded Clinical Trial
1 TrialsResearching Foot Surgery
502 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
This condition is classified as ASA physical status I, II, or III.
You are eligible for the study if you are aged 18 years or older.
Patients undergoing foot surgery who require a peripheral nerve block of the ankle as primary anesthesia.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.