Mepivacaine Versus Bupivacaine Onset Time in Ultrasound-guided Ankle Blocks
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mepivacaine, Bupivacaine.
- Who it may be relevant to
- Registry conditions: Ankle Block, Foot Surgery. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Onset of Sensory Blockade in Ultrasound-Guided Ankle Block With Mepivacaine Versus Bupivacaine: A Randomized Non-Inferiority Clinical Trial
Overview
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.
Interventions
- Drug Mepivacaine
Up to two 30 ml vials of mepivacaine 1.5% via ultrasound-guided nerve blockade of the tibial and deep peroneal nerves - 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
- Onset of sensory Blockage [Time frame: 20 minutes]
Secondary outcome measures (9)
- Block Failure [Time frame: 20 minutes]
- Pain Scores [Time frame: Post-procedural, approximately 2-4 hours]
- Total opioid received intra-operatively [Time frame: Intra-operatively, approximately 4-6 hours]
- Time to first opioid use [Time frame: 24 hours]
- Number of complications [Time frame: 24 hour]
- Total anesthesia-related time [Time frame: 20 minutes]
- Overall Benefit of Analgesia Score (OBAS) [Time frame: 24 hours after discharge]
- Total opioid use after discharge [Time frame: 24 hours after discharge]
- Duration of the ankle block [Time frame: 24 hours after discharge]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Mayo Clinic in Rochester — Rochester
Identifiers
NCT: NCT05425979 · 22-000140