NCT04454203 Femoral Peri-arterial Local Anesthetic Injection Via Peri-arterial Perineural Catheter Reverses Tourniquet Associated Ischemic Hypertension
| NCT ID | NCT04454203 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Duke University |
| Condition | Tourniquet Hypertension |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2021-02-05 |
| Primary Completion | 2027-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 40 participants in total. It began in 2021-02-05 with a primary completion date of 2027-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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: 1. ASA 4 or 5 2. Diagnosis of chronic pain 3. Daily chronic opioid use (over 3 months of continuous opioid use). 4. Inability to communicate pain scores or need for analgesia. 5. Infection at the site of block placement 6. Age under 18 years old or greater than 75 years old 7. Pregnant women (as determined by standard of care day-of surgery urine bHCG) 8. Intolerance/allergy to local anesthetics 9. Weight \<50 kg 10. Suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years. 11. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance. 12. 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
Contact & Investigator
Amanda Kumar, MD, PhD
PRINCIPAL INVESTIGATOR
Duke University
Frequently Asked Questions
Who can join the NCT04454203 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Tourniquet Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04454203 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04454203 currently recruiting?
Yes, NCT04454203 is actively recruiting participants. Contact the research team at william.bullock@duke.edu for enrollment information.
Where is the NCT04454203 trial being conducted?
This trial is being conducted at Durham, United States.
Who is sponsoring the NCT04454203 clinical trial?
NCT04454203 is sponsored by Duke University. The principal investigator is Amanda Kumar, MD, PhD at Duke University. The trial plans to enroll 40 participants.