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NCT04454203 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study of Intraoperative Hypertension and Total Ankle Arthroplasty, sponsored by Duke University.

Recruiting
Registry status
Phase 4
Development phase
40
Enrollment target
1
Study location

NCT04454203: Recruiting Phase 4 study of Intraoperative Hypertension and Total Ankle Arthroplasty, sponsored by Duke University.

NCT04454203 is a Phase 4 study of Intraoperative Hypertension and Total Ankle Arthroplasty that is actively recruiting participants, run by Duke University. The registered enrollment target is 40 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04454203, a Phase 4 study of Intraoperative Hypertension and Total Ankle Arthroplasty, is actively recruiting participants, sponsored by Duke University.

RECRUITING
Registry status
Phase 4
Development phase
40 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

Infiltrating study drug to reverse intraoperative tourniquet hypertension

Interventions

  • DRUG Saline
  • DRUG Mepivacaine
  • PROCEDURE Perifemoral Injection of Local Anesthetic

Study Locations (1)

North Carolina

  • Duke University Hospital - Durham

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2021-02-05
Est. Completion 2027-02-03
Phase Phase 4
Duke University

1,725 total trials

What NCT04454203 shows while recruiting

NCT04454203 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).

The record links to 4 conditions, with Intraoperative Hypertension appearing as the primary indexed condition, and to 3 interventions - of which Saline is the first listed.

NCT04454203 reports a single indexed study location in North Carolina.

Frequently Asked Questions

What is clinical trial NCT04454203 about?

NCT04454203 is a clinical study titled "Femoral Peri-arterial Local Anesthetic Injection Via Peri-arterial Perineural Catheter Reverses Tourniquet Associated Ischemic Hypertension". 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...

What is the current status of trial NCT04454203?

This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2021-02-05. Estimated completion is 2027-02-03.

What conditions does trial NCT04454203 study?

This clinical trial studies the following conditions: Intraoperative Hypertension, Total Ankle Arthroplasty, Ankle Fusion, Tourniquet Hypertension.

What interventions are being tested in trial NCT04454203?

The interventions under investigation include: Saline (DRUG), Mepivacaine (DRUG), Perifemoral Injection of Local Anesthetic (PROCEDURE).

Who is sponsoring clinical trial NCT04454203?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04454203 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Intraoperative Hypertension

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04454203's enrollment target sits among peer trials

40 1397th of 2000 higher than 534 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04454203, the US trial registry maintained by the National Library of Medicine. NCT04454203 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.