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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 is a Phase 4 study that has completed, run by Duke University. The registered enrollment target is 31 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03390426
The ClinicalTrials.gov registry entry for NCT03390426 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Saline is the first listed.
NCT03390426 reports 0 study locations.
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.
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