We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

Mepivacaine Versus Bupivacaine Onset Time in Ultrasound-guided Ankle Blocks

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05425979
Recruitment Status : Not yet recruiting
First Posted : June 21, 2022
Last Update Posted : February 23, 2023
Information provided by (Responsible Party):
Bridget P. Pulos, 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.

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

Layout table for study information
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

Resource links provided by the National Library of Medicine

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05425979

Layout table for location information
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Layout table for investigator information
Principal Investigator: Bridget Pulos, MD Mayo Clinic
Additional Information:
Layout table for additonal information
Responsible Party: Bridget P. Pulos, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT05425979    
Other Study ID Numbers: 22-000140
First Posted: June 21, 2022    Key Record Dates
Last Update Posted: February 23, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents