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NCT03390426 · ClinicalTrials.gov registry record · Phase 4
Femoral Peri-arterial Local Anesthetic Injection Decreases Tourniquet Associated Ischemic Hypertension
A Phase 4 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 4
- Development phase
- 31
- Enrollment target
NCT03390426: Completed Phase 4 study, sponsored by Duke University.
NCT03390426 is a Phase 4 study that has completed, run by Duke University. The registered enrollment target is 31 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03390426, a Phase 4 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 31 participants
- Enrollment target
Study Summary
The purpose of this prospective randomized double-blind study is to determine if the novel technique of ultrasound guided peri-arterial injection of local anesthetic around the femoral artery decreases ischemic hypertension associated with prolonged lower extremity tourniquet time during total ankle arthroplasty (TAA) and foot fusion surgeries. Patients will be randomized 1:1 to receive either local anesthetic or saline, which will be injected superomedially to the femoral artery in an attempt to block sympathetic afferents and decrease tourniquet associated hypertension intraoperatively.
Primary Outcome
Measuring systolic blood pressure using a cuff, aim to keep \<30mmHg change from baseline
Interventions
- DRUG Saline
- DRUG Mepivacaine
- PROCEDURE Perifemoral Injection of Local Anesthetic
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2018-05-03 |
| Est. Completion | 2018-10-28 |
| Phase | Phase 4 |
What the finished NCT03390426 record still lists
NCT03390426 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 3 interventions - of which Saline is the first listed.
NCT03390426 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03390426 about?
NCT03390426 is a clinical study titled "Femoral Peri-arterial Local Anesthetic Injection Decreases Tourniquet Associated Ischemic Hypertension". The purpose of this prospective randomized double-blind study is to determine if the novel technique of ultrasound guided peri-arterial injection of local anesthetic around the femoral artery decreases ischemic hypertension associated with prolonged lower extremity tourniquet time during total ankle...
What is the current status of trial NCT03390426?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 31 participants. The study started on 2018-05-03. Estimated completion is 2018-10-28.
What interventions are being tested in trial NCT03390426?
The interventions under investigation include: Saline (DRUG), Mepivacaine (DRUG), Perifemoral Injection of Local Anesthetic (PROCEDURE).
Who is sponsoring clinical trial NCT03390426?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03390426's enrollment target sits among peer trials
31 1544th of 2000 higher than 449 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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