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

Intraoperative Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04454203
• Other study ID #: Pro00104144
• Status: Recruiting
• Phase: Phase 4
• Start date: February 5, 2021
• Est. completion date: May 1, 2025

Study information

• Verified date: January 2024
• Source: Duke University
• Contact: William M Bullock, MD, PhD
• Phone: 919-681-6437
• Email: william.bullock[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 1, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Mepivacaine
An infiltration of mepivacaine superomedially to the femoral artery via perineural catheter.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Duke University Hospital	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in tourniquet hypertension as measured by systolic blood pressure	Infiltrating study drug to reverse intraoperative tourniquet hypertension	From time of injection to 30 minutes after injection
Secondary	Pain Scores (NRS11)	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")	Perioperative start until 2 hours after admission to PACU
Secondary	Opioid consumption	Perioperative opioid consumption as measured in oral morphine equivalents (OMEs)	Perioperative start until 2 hours after admission to PACU
Secondary	Quadriceps motor function	Gross quadriceps motor function as measured by leg extension	1 hour after extubation