Foot Surgery Clinical Trial
Official title:
Onset of Sensory Blockade in Ultrasound-Guided Ankle Block With Mepivacaine Versus Bupivacaine: A Randomized Non-Inferiority Clinical Trial
Verified date | March 2024 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 50 |
Est. completion date | December 2024 |
Est. primary completion date | July 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic in Rochester | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Onset of sensory Blockage | Time in minutes for successful surgical sensory blockade following the ankle block | 20 minutes | |
Secondary | Block Failure | Number of subjects to experience block failure as defined as opioid administration operatively and /or conversion to general anesthesia | 20 minutes | |
Secondary | 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) | Post-procedural, approximately 2-4 hours | |
Secondary | Total opioid received intra-operatively | Total amount of opioid received intra-operatively | Intra-operatively, approximately 4-6 hours | |
Secondary | Time to first opioid use | Time measured in minutes to the first opioid use | 24 hours | |
Secondary | Number of complications | Total number of procedural complications | 24 hour | |
Secondary | Total anesthesia-related time | Measured in minutes, defined as performance time plus onset time of local anesthesia | 20 minutes | |
Secondary | 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 | |
Secondary | Total opioid use after discharge | Total amount of opioids used used for pain control after discharge | 24 hours after discharge | |
Secondary | 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 |
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