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

NCT ID: NCT04454203

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-05
• Study Completion Date: 2026-02-03

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.

Conditions

Tourniquet Hypertension; Intraoperative Hypertension; Total Ankle Arthroplasty; Ankle Fusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Mepivacaine Block Group

Infiltration of local anesthetic (mepivacaine) above and beside the femoral artery through a perineural catheter.

Group Type: EXPERIMENTAL

Mepivacaine

Intervention Type: DRUG

An infiltration of mepivacaine superomedially to the femoral artery via perineural catheter.

Perifemoral Injection of Local Anesthetic

Intervention Type: PROCEDURE

Infiltration of mepivacaine superomedially to the formal artery via perineural catheter in an effort to numb the nerves that contribute to tourniquet hypertension intraoperatively.

Saline Sham Group

Infiltration of salt water (saline) above and beside the femoral artery through a perineural catheter.

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

An infiltration of saline superomedially to the femoral artery via perineural catheter.

Perifemoral Injection of Local Anesthetic

Intervention Type: PROCEDURE

Infiltration of saline superomedially to the formal artery via perineural catheter that should NOT numb the nerves that contribute to tourniquet hypertension intraoperatively.

Interventions

Mepivacaine

An infiltration of mepivacaine superomedially to the femoral artery via perineural catheter.

Intervention Type: DRUG

Saline

An infiltration of saline superomedially to the femoral artery via perineural catheter.

Intervention Type: DRUG

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

Carbocaine; Salt water placebo; Femoral Periarterial Injection; Femoral Periarterial Injection

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amanda Kumar, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

William M Bullock, MD, PhD

Role: STUDY_DIRECTOR

Duke University

Locations

Duke University Hospital

Durham, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

William M Bullock, MD, PhD

Role: CONTACT

william.bullock@duke.edu

919-681-6437

Jeff C Gadsden, MD

Role: CONTACT

jeff.gadsden@duke.edu

919-681-6437

Facility Contacts

William M Bullock, MD, PhD

Role: primary

william.bullock@duke.edu

919-681-6437

Amanda Kumar, MD

Role: backup

amanda.kumar@duke.edu

919-681-6437

Other Identifiers

Pro00104144

Identifier Type: -

Identifier Source: org_study_id