Mepivacaine Versus Bupivacaine Onset Time in Ultrasound-guided Ankle Blocks

• ClinicalTrials.gov Identifier: NCT05425979
• Recruitment Status: Not yet recruiting
• First Posted: June 21, 2022
• Last Update Posted: February 23, 2023
• Sponsor: Mayo Clinic
• Information provided by (Responsible Party): Bridget P. Pulos, Mayo Clinic

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Ankle Block; Foot Surgery	Drug: Mepivacaine; Drug: Bupivacaine	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Masking Description: 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
• Primary Purpose: Treatment
• Official Title: Onset of Sensory Blockade in Ultrasound-Guided Ankle Block With Mepivacaine Versus Bupivacaine: A Randomized Non-Inferiority Clinical Trial
• Estimated Study Start Date: June 2023
• Estimated Primary Completion Date: August 2023
• Estimated Study Completion Date: December 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Onset of sensory Blockage [ Time Frame: 20 minutes ]
   Time in minutes for successful surgical sensory blockade following the ankle block

Secondary Outcome Measures :

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

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

United States, Minnesota

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

Investigators

• Principal Investigator: Bridget Pulos, MD; Mayo Clinic

More Information

Additional Information:

Mayo Clinic Clinical Trials 

• Responsible Party: Bridget P. Pulos, Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT05425979
• Other Study ID Numbers: 22-000140
• First Posted: June 21, 2022
• Last Update Posted: February 23, 2023
• Last Verified: February 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by Bridget P. Pulos, Mayo Clinic:

Ultrasound-Guided Ankle Block; Regional anesthesia; Local anesthesia

Additional relevant MeSH terms:

Bupivacaine; Mepivacaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents