Femoral Peri-arterial Local Anesthetic Injection Decreases Tourniquet Associated Ischemic Hypertension

NCT03390426 | Completed Phase 4 Results FDA Drug

• 1 other identifier: Pro00089161
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this prospective randomized double-blind study is to determine if the novel technique of ultrasound guided peri-arterial injection of local anesthetic around the femoral artery decreases ischemic hypertension associated with prolonged lower extremity tourniquet time during total ankle arthroplasty (TAA) and foot fusion surgeries. Patients will be randomized 1:1 to receive either local anesthetic or saline, which will be injected superomedially to the femoral artery in an attempt to block sympathetic afferents and decrease tourniquet associated hypertension intraoperatively.

Conditions

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

Keywords

Perifemoral; Tourniquet; Mepivacaine; Tourniquet Hypertension

Outcome Measures

Primary Outcomes (1)

• Number of Subjects Experiencing Tourniquet Hypertension

  Measuring systolic blood pressure using a cuff, aim to keep \<30mmHg change from baseline

  Intraoperatively (~3 hours)

Secondary Outcomes (3)

• Pain Scores as Measured by the Numeric Rating Scale (NRS-11)

  While in PACU (~1 hour)

• Amount of Opioid Pain Medications Used by Patient

  Perioperative period (~4 hours)

• Amount of Esmolol Used Intraoperatively

  Intraoperatively (~3 hours)

Study Arms (2)

Mepivacaine Block Group

EXPERIMENTAL

Injection of local anesthetic (mepivacaine) above and beside the femoral artery.

Drug: Mepivacaine; Procedure: Perifemoral Injection of Local Anesthetic

Saline Sham Group

PLACEBO COMPARATOR

Injection of salt water (saline) above and beside the femoral artery.

Procedure: Perifemoral Injection of Local Anesthetic; Drug: Saline

Interventions

Mepivacaine DRUG

An ultrasound guided injection of mepivacaine superomedially to the femoral artery.

Also known as: Carbocaine

Mepivacaine Block Group

Perifemoral Injection of Local Anesthetic PROCEDURE

An ultrasound guided injection of mepivacaine superomedially to the formal artery in an effort to numb the nerves that contribute to tourniquet hypertension intraoperatively.

Also known as: Femoral periarterial injection

Mepivacaine Block Group; Saline Sham Group

Saline DRUG

An ultrasound guided injection using a medication that does NOT numb any nerves called saline, or salt water.

Also known as: Salt Water placebo

Saline Sham Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients that will be included in the study are English speaking 18-75 year old ASA 1-3 patients undergoing total ankle arthroplasty.

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Hospital

Durham, North Carolina, 27713, United States

Location

Related Publications (1)

• Wahal C, Grant SA, Gadsden J, Rambhia MT, Bullock WM. Femoral artery block (FAB) attenuates thigh tourniquet-induced hypertension: a prospective randomized, double-blind, placebo-controlled trial. Reg Anesth Pain Med. 2021 Mar;46(3):228-232. doi: 10.1136/rapm-2020-102113. Epub 2021 Jan 11.

  PMID: 33431616 DERIVED

MeSH Terms

Interventions

Mepivacaine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: William Michael Bullock, MD, PhD
• Organization: Duke University Medical Center

william.bullock@duke.edu

919-681-6437

Study Officials

• William M Bullock

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2017
• First Posted: January 4, 2018
• Study Start: May 3, 2018
• Primary Completion: October 27, 2018
• Study Completion: October 28, 2018
• Last Updated: May 5, 2021
• Results First Posted: October 30, 2019

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)