NCT04454203

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Tourniquet Hypertension
• Intraoperative Hypertension
• Total Ankle Arthroplasty
• Ankle Fusion

Interventions

Type	Name	Description
DRUG	Mepivacaine	An infiltration of mepivacaine superomedially to the femoral artery via perineural catheter.
DRUG	Saline	An infiltration of saline superomedially to the femoral artery via perineural catheter.
PROCEDURE	Perifemoral Injection of Local Anesthetic	Infiltration of mepivacaine superomedially to the formal artery via perineural catheter in an effort to numb the nerves that contribute to tourniquet hypertension intraoperatively.
PROCEDURE	Perifemoral Injection of Local Anesthetic	Infiltration of saline superomedially to the formal artery via perineural catheter that should NOT numb the nerves that contribute to tourniquet hypertension intraoperatively.

Timeline

• Start date: 2021-02-05
• Primary completion: 2027-02-01
• Completion: 2027-02-03
• First posted: 2020-07-01
• Last updated: 2026-03-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study