Ankle Block, Foot Surgery
Conditions
Keywords
Ultrasound-Guided Ankle Block, Regional anesthesia, Local anesthesia
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.
Interventions
DRUGMepivacaine
Up to two 30 ml vials of mepivacaine 1.5% via ultrasound-guided nerve blockade of the tibial and deep peroneal nerves
DRUGBupivacaine
Up to two 30 ml vials of bupivacaine 0.5% via ultrasound-guided nerve blockade of the tibial and deep peroneal nerves
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, 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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Onset of sensory Blockage | 20 minutes | Time in minutes for successful surgical sensory blockade following the ankle block |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Block Failure | 20 minutes | Number of subjects to experience block failure as defined as opioid administration operatively and /or conversion to general 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 |
| Total anesthesia-related time | 20 minutes | Measured in minutes, defined as performance time plus onset time of local anesthesia |
Countries
United States
Outcome results
None listed