RECRUITING

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

Conditions

Tourniquet Hypertension Intraoperative Hypertension Total Ankle Arthroplasty Ankle Fusion Perifemoral Tourniquet Mepivacaine

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-02-05

Study Completion:2025-05-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04454203

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
Age 18 years or older Willing and able to provide informed consent Able to understand and follow study procedures Stable medical condition	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

Inclusion Criteria

Exclusion Criteria

Age 18 years or older
Willing and able to provide informed consent
Able to understand and follow study procedures
Stable medical condition

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

Contacts and Locations

Study Contact

William M Bullock, MD, PhD

CONTACT

919-681-6437

william.bullock@duke.edu

Jeff C Gadsden, MD

CONTACT

919-681-6437

jeff.gadsden@duke.edu

Principal Investigator

Amanda Kumar, MD, PhD

PRINCIPAL_INVESTIGATOR

Duke University

William M Bullock, MD, PhD

STUDY_DIRECTOR

Duke University

Study Locations (Sites)

Duke University Hospital

Durham, North Carolina, 27710

United States

Collaborators and Investigators

Sponsor: Duke University

Amanda Kumar, MD, PhD, PRINCIPAL_INVESTIGATOR, Duke University
William M Bullock, MD, PhD, STUDY_DIRECTOR, Duke University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-02-05

Study Completion Date2025-05-01

Study Record Updates

Study Start Date2021-02-05

Study Completion Date2025-05-01

Terms related to this study

Keywords Provided by Researchers

Perifemoral
Tourniquet
Mepivacaine
Tourniquet Hypertension

Additional Relevant MeSH Terms

Tourniquet Hypertension
Intraoperative Hypertension
Total Ankle Arthroplasty
Ankle Fusion