Femoral Peri-arterial Local Anesthetic Injection Via Peri... | NCT04454203

Studies
Femoral Peri-arterial Local Anesthetic Injection Via Peri-arterial Perineural Catheter Reverses Tourniquet Associated Ischemic Hypertension

NCT04454203

Sponsor

Duke University

Status

Recruiting

Last Update Posted

Mar 23, 2026Actual

Enrollment

40Estimated

Phase

Phase 4

Conditions

Tourniquet Hypertension
Intraoperative Hypertension
Total Ankle Arthroplasty
Ankle Fusion

Interventions

Mepivacaine
Saline
Perifemoral Injection of Local Anesthetic
Perifemoral Injection of Local Anesthetic

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 5, 2021Actual

Primary Completion Date

Feb 1, 2027Estimated

Completion Date

Feb 3, 2027Estimated

First Submitted Date

Jun 29, 2020

First Submission Date that Met QC Criteria

Jun 29, 2020

First Posted Date

Jul 1, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 20, 2026

Last Update Posted Date

Mar 23, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this prospective randomized double-blind study is to determine if an ultrasound guided peri-arterial injection of local anesthetic (LA) superomedially the femoral artery via peripheral nerve catheter reverses ischemic hypertension associated with prolonged lower extremity tourniquet time.

Detailed Description

This is a research study to find out if injection of numbing medication by the large artery going down your leg will improve high blood pressure caused by the tourniquet.

Depending on whether you enroll in this study, you may receive an injection of local anesthetic (numbing medication) or saline (salt water) by your femoral artery (the large artery going down your leg). This is to see how this injection impacts your blood pressure during surgery as the surgeons use a tourniquet (device that squeezes your leg) to help decrease the bleeding during surgery. Oftentimes the tourniquet causes your blood pressure to go up, but the numbing medication may help return your blood pressure close to its normal level. The rest of your anesthesia care, including other nerve blocks and general anesthetic, will be the same as it would be without participating in the study. You will be enrolled in this study for 24 hours.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mepivacaine Block Group	Experimental	Infiltration of local anesthetic (mepivacaine) above and beside the femoral artery through a perineural catheter.	Drug: Mepivacaine Procedure: Perifemoral Injection of Local Anesthetic
Saline Sham Group	Placebo Comparator	Infiltration of salt water (saline) above and beside the femoral artery through a perineural catheter.	Drug: Saline Procedure: Perifemoral Injection of Local Anesthetic

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mepivacaine	Drug	An infiltration of mepivacaine superomedially to the femoral artery via perineural catheter.	Mepivacaine Block Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in tourniquet hypertension as measured by systolic blood pressure	Infiltrating study drug to reverse intraoperative tourniquet hypertension	From time of injection to 30 minutes after injection

Secondary Outcomes

Measure	Description	Time Frame
Pain Scores (NRS11)	The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")	Perioperative start until 2 hours after admission to PACU
Opioid consumption

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients that will be included in the study are English speaking 18-75 year old ASA 1-3 patients undergoing total ankle arthroplasty.

Exclusion Criteria:

ASA 4 or 5
Diagnosis of chronic pain
Daily chronic opioid use (over 3 months of continuous opioid use).
Inability to communicate pain scores or need for analgesia.
Infection at the site of block placement
Age under 18 years old or greater than 75 years old
Pregnant women (as determined by standard of care day-of surgery urine bHCG)
Intolerance/allergy to local anesthetics
Weight <50 kg
Suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance.
Current or historical evidence of any clinically significant disease or condition that, in the opinion of the investigator, may increase the risk of surgery or complicate the subject's postoperative course

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
William M Bullock, MD, PhD	Contact	919-681-6437		william.bullock@duke.edu
Jeff C Gadsden, MD	Contact	919-681-6437		jeff.gadsden@duke.edu

Overall Officials

Name	Affiliation	Role
Amanda Kumar, MD, PhD	Duke University	Principal Investigator
William M Bullock, MD, PhD	Duke University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Duke University Hospital	Recruiting	Durham	North Carolina	27710	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Individual participant data will not be shared; patients will be deidentified and no personal information or medical records used.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

MeSH Terms

ID	Term
D010880	Piperidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D002712	Chlorides
D006851	Hydrochloric Acid
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017670	Sodium Compounds

ID	Term
D008619	Mepivacaine
D012965	Sodium Chloride