Perifemoral Injection of Local Anesthetic for Tourniquet Hypertension

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Duke University Hospital, Durham, NCTourniquet Hypertension+3 MorePerifemoral Injection of Local Anesthetic - Procedure
Eligibility
18 - 75
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Tourniquet Hypertension
  • Total Ankle Replacement
  • Ankle Arthrodesis
  • Intraoperative Hypertension

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: From time of injection to 30 minutes after injection

1 hour after extubation
Quadriceps motor function
From time of injection to 30 minutes after injection
Change in tourniquet hypertension as measured by systolic blood pressure
Hour 2
Opioid consumption
Pain Scores (NRS11)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Mepivacaine Block Group
1 of 2
Saline Sham Group
1 of 2

Experimental Treatment

Non-Treatment Group

40 Total Participants · 2 Treatment Groups

Primary Treatment: Perifemoral Injection of Local Anesthetic · Has Placebo Group · Phase 4

Mepivacaine Block GroupExperimental Group · 2 Interventions: Perifemoral Injection of Local Anesthetic, Mepivacaine · Intervention Types: Procedure, Drug
Saline Sham GroupPlaceboComparator Group · 2 Interventions: Saline, Perifemoral Injection of Local Anesthetic · Intervention Types: Drug, Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Perifemoral Injection of Local Anesthetic
2018
Completed Phase 4
~40
Mepivacaine
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from time of injection to 30 minutes after injection

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,207 Previous Clinical Trials
3,220,456 Total Patients Enrolled
1 Trials studying Tourniquet Hypertension
31 Patients Enrolled for Tourniquet Hypertension
William M Bullock, MD, PhDStudy DirectorDuke University
Amanda Kumar, MD, PhDPrincipal InvestigatorDuke University

Eligibility Criteria

Age 18 - 75 · All Participants · 1 Total Inclusion Criteria

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Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.