Mepivacaine Versus Bupivacaine Onset Time in Ultrasound-guided Ankle Blocks
Study Details
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 |
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Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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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
- Onset of sensory Blockage [20 minutes]
Time in minutes for successful surgical sensory blockade following the ankle block
Secondary Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age greater than or equal to 18 years old.
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Patients who provide informed consent to participate.
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Patients undergoing foot surgery who require a peripheral nerve block of the ankle as primary anesthesia.
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ASA (American Society of Anesthesiology) Physical Status Classification I - III.
Exclusion Criteria:
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Inability to consent.
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Allergy to local anesthetic.
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Infection at site of injection.
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Pregnancy.
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Coagulopathy.
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Hepatic or renal failure.
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Preexisting neuropathy in operative limb.
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Planned spinal anesthetic or general anesthesia.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Mayo Clinic in Rochester | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
Investigators
- Principal Investigator: Bridget Pulos, MD, Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 22-000140