Sternotomy PIFB Block in Open Heart Surgery

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.

Conditions

Autonomic Nerve Block

Study Overview

Study Details

Study overview

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.

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

Sternotomy PIFB Block in Open Heart Surgery

Condition
Autonomic Nerve Block
Intervention / Treatment

-

Contacts and Locations

Columbus

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Adult male or female patients aged \> 18
  • * Undergoing primary cardiac surgery requiring sternotomy
  • * Able to provide a signed written informed consent
  • * Able to speak, read, and write in English
  • * American Society of Anesthesiologists (ASA) physical status I-IV
  • * Any documented cognitive or psychological disorders that, in the opinion of the principal investigator, can interfere with the patients' pain perception
  • * Diabetes Mellitus with documented neuropathic pain
  • * Vulnerable populations: pregnant females, prisoners, breast feeding
  • * Contraindication to nerve block: local infections, bleeding disorders, chest wall deformity, allergy to local anesthetic or dexamethasone
  • * Previous cardiac surgery
  • * Previous history of chronic pain diseases requiring consistent analgesic therapy for at least 1 month prior to surgery
  • * Presence of any medical condition that, in the opinion of the principal investigator, should exclude the patient from the study
  • * BMI ≥ 40 kg/m2

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Ohio State University,

Study Record Dates

2027-01-31