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

Phase 4

Recruiting

• Conditions: Intraoperative Hypertension; Ankle Fusion; Tourniquet Hypertension; Total Ankle Arthroplasty
• Interventions: Drug: Saline; Drug: Mepivacaine; Procedure: Perifemoral Injection of Local Anesthetic

• Registration Number: NCT04454203
• Lead Sponsor: Duke University

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.

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.

Study Timeline

• Study First Submitted: 2020-06-29
• Study First Submitted QC: 2020-06-29
• Study First Posted: 2020-07-01
• Study Start: 2021-02-05
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-04
• Primary Completion: 2026-02-01
• Study Completion: 2026-02-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline Sham Group	Saline	Infiltration of salt water (saline) above and beside the femoral artery through a perineural catheter.
Mepivacaine Block Group	Perifemoral Injection of Local Anesthetic	Infiltration of local anesthetic (mepivacaine) above and beside the femoral artery through a perineural catheter.
Saline Sham Group	Perifemoral Injection of Local Anesthetic	Infiltration of salt water (saline) above and beside the femoral artery through a perineural catheter.
Mepivacaine Block Group	Mepivacaine	Infiltration of local anesthetic (mepivacaine) above and beside the femoral artery through a perineural catheter.

Primary Outcome Measures

Name	Time	Method
Change in tourniquet hypertension as measured by systolic blood pressure	From time of injection to 30 minutes after injection	Infiltrating study drug to reverse intraoperative tourniquet hypertension

Secondary Outcome Measures

Name	Time	Method
Opioid consumption	Perioperative start until 2 hours after admission to PACU	Perioperative opioid consumption as measured in oral morphine equivalents (OMEs)
Pain Scores (NRS11)	Perioperative start until 2 hours after admission to PACU	The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
Quadriceps motor function	1 hour after extubation	Gross quadriceps motor function as measured by leg extension

Trial Locations

Locations (1)

Duke University Hospital; 🇺🇸 Durham, North Carolina, United States