Mepivacaine Versus Bupivacaine Onset Time in Ultrasound-guided Ankle Blocks

Phase 4

• Conditions: Ankle Block; Foot Surgery
• Interventions: Drug: Mepivacaine; Drug: Bupivacaine

• Registration Number: NCT05425979
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-16
• Study First Submitted QC: 2022-06-16
• Study First Posted: 2022-06-21
• Status Verified: 2024-03
• Study Start: 2024-03-11
• Last Update Submitted: 2024-03-11
• Last Update Posted: 2024-03-13
• Primary Completion: 2024-07-01
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mepivacaine group	Mepivacaine	Subjects will receive an ultrasound-guided peripheral nerve block at the ankle with mepivacaine prior to undergoing foot surgery
Bupivacaine group	Bupivacaine	Subjects will receive an ultrasound-guided peripheral nerve block at the ankle with bupivacaine prior to undergoing foot surgery

Primary Outcome Measures

Name	Time	Method
Onset of sensory Blockage	20 minutes	Time in minutes for successful surgical sensory blockade following the ankle block

Secondary Outcome Measures

Name	Time	Method
Block Failure	20 minutes	Number of subjects to experience block failure as defined as opioid administration operatively and /or conversion to general anesthesia
Pain Scores	Post-procedural, approximately 2-4 hours	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)
Total opioid received intra-operatively	Intra-operatively, approximately 4-6 hours	Total amount of opioid received intra-operatively
Time to first opioid use	24 hours	Time measured in minutes to the first opioid use
Number of complications	24 hour	Total number of procedural complications
Total anesthesia-related time	20 minutes	Measured in minutes, defined as performance time plus onset time of local anesthesia
Overall Benefit of Analgesia Score (OBAS)	24 hours after discharge	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
Total opioid use after discharge	24 hours after discharge	Total amount of opioids used used for pain control after discharge
Duration of the ankle block	24 hours after discharge	Length of time measured in minutes the patient to felt until the ankle block completely wore off

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States