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Enrolling by Invitation

NCT Number: NCT05425979

Mepivacaine Versus Bupivacaine Onset Time in Ultrasound-guided Ankle Blocks

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.

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Key information

Conditions

Ankle Block Foot Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mepivacaine

Drug

Up to two 30 ml vials of mepivacaine 1.5% via ultrasound-guided nerve blockade of the tibial and deep peroneal nerves

Bupivacaine

Drug

Up to two 30 ml vials of bupivacaine 0.5% via ultrasound-guided nerve blockade of the tibial and deep peroneal nerves

Primary outcomes

  1. Onset of sensory Blockage

    Time frame: 20 minutes

    Time in minutes for successful surgical sensory blockade following the ankle block

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jun 21, 2022
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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