Ankle BlockPhase 4NCT05425979
Mepivacaine Versus Bupivacaine Onset Time in Ultrasound-guided Ankle Blocks
A Phase 4 study testing Mepivacaine and Bupivacaine in people with Ankle Block and Foot Surgery, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankle Block, Foot Surgery
- What is being tested?
- Mepivacaine and Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2024to 30 Mar 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Onset of Sensory Blockade in Ultrasound-Guided Ankle Block With Mepivacaine Versus Bupivacaine: A Randomized Non-Inferiority Clinical Trial
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.
- Conditions
- Ankle Block, Foot Surgery
- Being tested
- Mepivacaine, Bupivacaine
- Keywords
- Ultrasound-Guided Ankle Block, Regional anesthesia, Local anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MepivacaineDrug
Up to two 30 ml vials of mepivacaine 1.5% via ultrasound-guided nerve blockade of the tibial and deep peroneal nerves
BupivacaineDrug
Up to two 30 ml vials of bupivacaine 0.5% via ultrasound-guided nerve blockade of the tibial and deep peroneal nerves
| Study group | Role | What they receive |
|---|---|---|
| Mepivacaine group | Active comparator | Subjects will receive an ultrasound-guided peripheral nerve block at the ankle with mepivacaine prior to undergoing foot surgery Receives: Drug: Mepivacaine |
| Bupivacaine group | Active comparator | Subjects will receive an ultrasound-guided peripheral nerve block at the ankle with bupivacaine prior to undergoing foot surgery Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset of sensory Blockage
Time in minutes for successful surgical sensory blockade following the ankle block
Measured: 20 minutes
Secondary outcomes (9)
Block Failure
Number of subjects to experience block failure as defined as opioid administration operatively and /or conversion to general anesthesia
Measured: 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)
Measured: Post-procedural, approximately 2-4 hours
Total opioid received intra-operatively
Total amount of opioid received intra-operatively
Measured: Intra-operatively, approximately 4-6 hours
Time to first opioid use
Time measured in minutes to the first opioid use
Measured: 24 hours
Number of complications
Total number of procedural complications
Measured: 24 hour
Total anesthesia-related time
Measured in minutes, defined as performance time plus onset time of local anesthesia
Measured: 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
Measured: 24 hours after discharge
Total opioid use after discharge
Total amount of opioids used used for pain control after discharge
Measured: 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
Measured: 24 hours after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start11 Mar 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle BlockStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bridget P. Pulos, Mayo Clinic
- Investigators
- Bridget Pulos, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05425979
- Sponsor's protocol ID
- 22-000140
- Status last verified
- Sep 2026
- First submitted
- 16 Jun 2022
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Onset of Sensory Blockade in Ultrasound-Guided Ankle Block With Mepivacaine Versus Bupivacaine: A Randomized Non-Inferiority Clinical Trial
- ClinicalTrials.gov ID
- NCT05425979
- Acronym / sponsor ID
- 22-000140
- Conditions
- Ankle Block, Foot Surgery
- Keywords
- Ultrasound-Guided Ankle Block, Regional anesthesia, Local anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 21 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mepivacaine group | Active comparator | Drug: MepivacaineSubjects will receive an ultrasound-guided peripheral nerve block at the ankle with mepivacaine prior to undergoing foot surgery |
| Bupivacaine group | Active comparator | Drug: BupivacaineSubjects will receive an ultrasound-guided peripheral nerve block at the ankle with bupivacaine prior to undergoing foot surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- Inability to consent.
- Allergy to local anesthetic.
- Infection at site of injection.
- Pregnancy.
- Coagulopathy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MepivacaineUp to two 30 ml vials of mepivacaine 1.5% via ultrasound-guided nerve blockade of the tibial and deep peroneal nerves | Drug | Mepivacaine group |
| BupivacaineUp to two 30 ml vials of bupivacaine 0.5% via ultrasound-guided nerve blockade of the tibial and deep peroneal nerves | Drug | Bupivacaine group |
Primary outcome
Onset of sensory Blockage
Time frame: 20 minutes
Time in minutes for successful surgical sensory blockade following the ankle block
9 secondary outcomes
Block Failure
Time frame: 20 minutes
Pain Scores
Time frame: Post-procedural, approximately 2-4 hours
Total opioid received intra-operatively
Time frame: Intra-operatively, approximately 4-6 hours
Time to first opioid use
Time frame: 24 hours
Number of complications
Time frame: 24 hour
Total anesthesia-related time
Time frame: 20 minutes
Overall Benefit of Analgesia Score (OBAS)
Time frame: 24 hours after discharge
Total opioid use after discharge
Time frame: 24 hours after discharge
Duration of the ankle block
Time frame: 24 hours after discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Ankle Block
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Liposomal Bupivacaine Versus Continuous Peripheral Nerve Blocks for Analgesia Following Ankle Surgery
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Quality of Recovery at Days 5-7 After Ankle Surgery: a Multicenter Study in Seine-Maritime
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bridget Pulos, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mepivacaine and Bupivacaine in people with Ankle Block and Foot Surgery, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Onset of sensory Blockage (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.