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

Sponsor

Duke University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04454203

Collaborator

(none)

Enrollment

Location

Arms

26.8

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tourniquet Hypertension Intraoperative Hypertension Total Ankle Arthroplasty Ankle Fusion	Drug: Mepivacaine Drug: Saline Procedure: Perifemoral Injection of Local Anesthetic Procedure: Perifemoral Injection of Local Anesthetic	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Feb 5, 2021

Anticipated Primary Completion Date :

Feb 1, 2023

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mepivacaine Block Group Infiltration of local anesthetic (mepivacaine) above and beside the femoral artery through a perineural catheter.	Drug: Mepivacaine An infiltration of mepivacaine superomedially to the femoral artery via perineural catheter. Other Names: Carbocaine 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. Other Names: Femoral Periarterial Injection
Placebo Comparator: Saline Sham Group Infiltration of salt water (saline) above and beside the femoral artery through a perineural catheter.	Drug: Saline An infiltration of saline superomedially to the femoral artery via perineural catheter. Other Names: Salt water placebo 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. Other Names: Femoral Periarterial Injection

Arm

Intervention/Treatment

Experimental: Mepivacaine Block Group

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

Drug: Mepivacaine

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

Other Names:

Carbocaine

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.

Other Names:

Femoral Periarterial Injection

Placebo Comparator: Saline Sham Group

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

Drug: Saline

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

Other Names:

Salt water placebo

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.

Other Names:

Femoral Periarterial Injection

Outcome Measures

Primary Outcome Measures

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

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")
Opioid consumption [Perioperative start until 2 hours after admission to PACU]
Perioperative opioid consumption as measured in oral morphine equivalents (OMEs)
Quadriceps motor function [1 hour after extubation]
Gross quadriceps motor function as measured by leg extension

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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:

ASA 4 or 5
Diagnosis of chronic pain
Daily chronic opioid use (over 3 months of continuous opioid use).
Inability to communicate pain scores or need for analgesia.
Infection at the site of block placement
Age under 18 years old or greater than 75 years old
Pregnant women (as determined by standard of care day-of surgery urine bHCG)
Intolerance/allergy to local anesthetics
Weight <50 kg
Suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance.
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