RECRUITING

Sternotomy PIFB Block in Open Heart Surgery

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 purpose of this study is to evaluate if the use of a bilateral nerve block with a local anesthetic (ropivacaine), as part of a standard of care pain control regimen (called multimodal analgesia \[MMA\]), has a favorable effect on our institutional MMA pain regimen. Subjects will go through the following study procedures: review of medical history and medications subjects have taken within a month prior to surgery. Subjects will be randomly assigned to one of the two study groups (1:1) to receive either, an ultrasound-guided bilateral nerve block (called "Pecto-Intercostal Fascial Block \[PIFB\]") with ropivacaine or saline 0.9 solution, in addition to our institutional MMA regimen. A baseline line pain and nausea scores will be recorded before surgery. The block will be performed right after general anesthesia induction. The details about the surgery will be collected. Pain assessments, nausea and vomiting scores will be registered at 12, 24 and 48 hours after surgery as well. Lastly, a follow up phone call will be made by the research team to conduct a pain-detect questionnaire at 30, 60 and 90 days after surgery.

Official Title

Efficacy of Bilateral Pecto-Intercostal Fascial Plane Block on Postoperative Pain in Adult Patients Undergoing Open Heart Surgery: A Randomized, Double-blind, Controlled Trial

Quick Facts

Study Start:2023-10-16
Study Completion:2027-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06233318

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
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult male or female patients aged \> 18
  2. * Undergoing primary cardiac surgery requiring sternotomy
  3. * Able to provide a signed written informed consent
  4. * Able to speak, read, and write in English
  5. * American Society of Anesthesiologists (ASA) physical status I-IV
  1. * Any documented cognitive or psychological disorders that, in the opinion of the principal investigator, can interfere with the patients' pain perception
  2. * Diabetes Mellitus with documented neuropathic pain
  3. * Vulnerable populations: pregnant females, prisoners, breast feeding
  4. * Contraindication to nerve block: local infections, bleeding disorders, chest wall deformity, allergy to local anesthetic or dexamethasone
  5. * Previous cardiac surgery
  6. * Previous history of chronic pain diseases requiring consistent analgesic therapy for at least 1 month prior to surgery
  7. * Presence of any medical condition that, in the opinion of the principal investigator, should exclude the patient from the study
  8. * BMI ≥ 40 kg/m2

Contacts and Locations

Study Contact

Alberto A Uribe
CONTACT
6142930775
alberto.uribe@osumc.edu
Jeremy Reeves
CONTACT
6142933559
jeremy.reeves@osumc.edu

Study Locations (Sites)

The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
United States

Collaborators and Investigators

Sponsor: Ohio State 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 Date2023-10-16
Study Completion Date2027-01-31

Study Record Updates

Study Start Date2023-10-16
Study Completion Date2027-01-31

Terms related to this study

Additional Relevant MeSH Terms

  • Autonomic Nerve Block