Mepivacaine Versus Bupivacaine Onset Time in Ultrasound-guided Ankle Blocks

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05425979
• Other study ID #: 22-000140
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: March 11, 2024
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Foot Surgery

Intervention

Drug:
• Mepivacaine
Up to two 30 ml vials of mepivacaine 1.5% via ultrasound-guided nerve blockade of the tibial and deep peroneal nerves
• Bupivacaine
Up to two 30 ml vials of bupivacaine 0.5% via ultrasound-guided nerve blockade of the tibial and deep peroneal nerves

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

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