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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
Must not have
Inability to communicate pain scores or need for analgesia
Age under 18 years old or greater than 75 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from time of injection to 30 minutes after injection
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved

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.
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.
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
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I am between 18-75 years old, speak English, and am having ankle surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot communicate my pain levels or need for pain relief.
Select...
I am either younger than 18 or older than 75.
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I have an infection where my medical block was placed.
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My health is severely limited by my illness.
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I weigh less than 50 kg.

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

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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

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
~23710

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,452 Previous Clinical Trials
2,971,751 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
~2 spots leftby Feb 2025
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