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Local Anesthetic

Local Anesthetic Injection for High Blood Pressure

Phase 4
Recruiting
Led By Amanda Kumar, MD, PhD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
English speaking 18-75 year old ASA 1-3 patients undergoing total ankle arthroplasty
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from time of injection to 30 minutes after injection
Awards & highlights

Study Summary

This trial will study whether injecting local anesthetic near the femoral artery can reduce ischemic hypertension caused by a prolonged tourniquet on the lower extremity.

Who is the study for?
This trial is for English-speaking adults aged 18-75 with good overall health (ASA 1-3) who are getting a total ankle replacement. It's not for pregnant women, those over 75 or under 18, people allergic to local anesthetics, underweight individuals (<50 kg), or anyone with conditions that could complicate surgery.Check my eligibility
What is being tested?
The study tests if injecting a local anesthetic near the femoral artery can reverse high blood pressure caused by a tourniquet during ankle surgery. Participants will be randomly chosen to receive either saline or mepivacaine through a catheter and won't know which one they get.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site, low blood pressure if the hypertension is reversed too quickly, and typical risks associated with local anesthetics like numbness and tingling.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18-75 years old, speak English, and am having ankle surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from time of injection to 30 minutes after injection
This trial's timeline: 3 weeks for screening, Varies for treatment, and from time of injection to 30 minutes after injection for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in tourniquet hypertension as measured by systolic blood pressure
Secondary outcome measures
Opioid consumption
Pain Scores (NRS11)
Quadriceps motor function

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Mepivacaine Block GroupExperimental Treatment2 Interventions
Infiltration of local anesthetic (mepivacaine) above and beside the femoral artery through a perineural catheter.
Group II: Saline Sham GroupPlacebo Group2 Interventions
Infiltration of salt water (saline) above and beside the femoral artery through a perineural catheter.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Perifemoral Injection of Local Anesthetic
2018
Completed Phase 4
~40
Mepivacaine
2013
Completed Phase 4
~23660

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,363 Previous Clinical Trials
3,420,469 Total Patients Enrolled
1 Trials studying Tourniquet Hypertension
31 Patients Enrolled for Tourniquet Hypertension
Amanda Kumar, MD, PhDPrincipal InvestigatorDuke University
William M Bullock, MD, PhDStudy DirectorDuke University

Media Library

Mepivacaine (Local Anesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT04454203 — Phase 4
Tourniquet Hypertension Research Study Groups: Mepivacaine Block Group, Saline Sham Group
Tourniquet Hypertension Clinical Trial 2023: Mepivacaine Highlights & Side Effects. Trial Name: NCT04454203 — Phase 4
Mepivacaine (Local Anesthetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04454203 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned Perifemoral Injection of Local Anesthetic?

"The safety of Perifemoral Injection of Local Anesthetic is estimated to be a 3 since this procedure has been approved by the relevant authorities, which puts it in Phase 4."

Answered by AI

Are there any remaining availabilities for participants in this experiment?

"As per the data available on clinicaltrials.gov, this scientific trial is actively seeking participants. These experiments began to be posted on February 5th 2021 and have been recently updated as of February 21st 2022."

Answered by AI

How many individuals are being tracked for the purpose of this research endeavor?

"Affirmative. The information posted on clinicaltrials.gov suggests that this medical research is actively searching for participants, first appearing on February 5th 2021 and updated as of February 21st 2022. 40 patients are desired from one location to take part in the trial."

Answered by AI

Is geriatric recruitment being considered for this experimental protocol?

"The age range for participants in this clinical trial is 18 to 75. For those under the legal age, there are 55 separate trials documented while 664 studies have been conducted with persons over 65 years old."

Answered by AI

Who qualifies to become a participant in this experiment?

"Eligible patients must be between 18 - 75 years of age and present with tourniquet hypertension. Approximately 40 participants are required to complete the trial."

Answered by AI

To what kind of medical conditions does Perifemoral Injection of Local Anesthetic provide relief?

"Diabetic peripheral neuropathy (DPN) can be managed through Perifemoral Injection of Local Anesthetic. This form of treatment is also beneficial for conditions such as nerve block, local anesthesia, and vitamin B 6 deficiency."

Answered by AI
~8 spots leftby Feb 2025