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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mepivacaine group | Active Comparator | Subjects will receive an ultrasound-guided peripheral nerve block at the ankle with mepivacaine prior to undergoing foot surgery |
|
| Bupivacaine group | Active Comparator | Subjects will receive an ultrasound-guided peripheral nerve block at the ankle with bupivacaine prior to undergoing foot surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mepivacaine | Drug | Up to two 30 ml vials of mepivacaine 1.5% via ultrasound-guided nerve blockade of the tibial and deep peroneal nerves |
|
| Measure | Description | Time Frame |
|---|---|---|
| Onset of sensory Blockage | Time in minutes for successful surgical sensory blockade following the ankle block | 20 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Block Failure | Number of subjects to experience block failure as defined as opioid administration operatively and /or conversion to general anesthesia | 20 minutes |
| Pain Scores | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bridget Pulos, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D008619 | Mepivacaine |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000813 | Anilides |
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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
| Bupivacaine | Drug | Up to two 30 ml vials of bupivacaine 0.5% via ultrasound-guided nerve blockade of the tibial and deep peroneal nerves |
|
| Post-procedural, approximately 2-4 hours |
| Total opioid received intra-operatively | Total amount of opioid received intra-operatively | Intra-operatively, approximately 4-6 hours |
| Time to first opioid use | Time measured in minutes to the first opioid use | 24 hours |
| Number of complications | Total number of procedural complications | 24 hour |
| Total anesthesia-related time | Measured in minutes, defined as performance time plus onset time of local anesthesia | 20 minutes |
| Overall Benefit of Analgesia Score (OBAS) | 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 | 24 hours after discharge |
| Total opioid use after discharge | Total amount of opioids used used for pain control after discharge | 24 hours after discharge |
| Duration of the ankle block | Length of time measured in minutes the patient to felt until the ankle block completely wore off | 24 hours after discharge |
| D000577 |
| Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |