Sternotomy PIFB Block in Open Heart Surgery

Not Applicable

Recruiting

• Conditions: Autonomic Nerve Block
• Interventions: Procedure: Pecto-intercostal Fascial Block with 20 ml of 0.35% ropivacaine; Procedure: Pecto-intercostal Fascial Block with normal saline

• Registration Number: NCT06233318
• Lead Sponsor: Ohio State University

Brief Summary

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.

Detailed Description

Study design This is a single-center, prospective, randomized, placebo-controlled, double-blinded trial in patients undergoing open-heart surgery at Richard M. Ross Hospital - The Ohio State University Medical Center. All study procedures will be done in accordance with institutional and ORRP-IRB guidelines.

Study participants Adult patients undergoing open-heart surgery at Richard M. Ross Hospital - The Ohio State University Medical Center with an American Society of Anesthesiologists (ASA) physical status of I to IV who are scheduled to undergo open-heart surgery at Richard M. Ross Hospital - The Ohio State University Medical Center.

Sample size Eighty-four subjects who give written informed consent to participate in the study and who meet all inclusion and no exclusion criteria will be included in a single treatment group.

Study Timeline

• Study Start: 2023-10-16
• Study First Submitted: 2024-01-12
• Study First Submitted QC: 2024-01-22
• Study First Posted: 2024-01-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-27
• Primary Completion: 2026-12-31
• Study Completion: 2027-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 84

Inclusion 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pecto-intercostal fascial block	Pecto-intercostal Fascial Block with 20 ml of 0.35% ropivacaine	Pecto-intercostal Fascial Block with 20 ml of 0.35% ropivacaine injected to each side under ultrasound visualization.
Placebo	Pecto-intercostal Fascial Block with normal saline	Pecto-intercostal Fascial Block with 20ml of normal saline injected to each side under ultrasound visualization.

Primary Outcome Measures

Name	Time	Method
OPIOID consumption during surgery	Surgery length	To compare the amount of opioid consumption oral MME consumption during surgery between groups
OPIOID consumption at 24 hours	24 hours after block procedure	To compare the effect of bilateral PIFB on perioperative opioid consumption (MME) during the first 24 hours after surgery between groups
Worst pain score at 48 hours	Up to 48 hours after block procedure	To compare the worst pain experienced during up to 48-hours after surgery between groups
Incidence nausea and/or vomiting after surgery	Up to 48 hours after block procedure	To compare the incidence of nausea and/or vomiting up to 48-hours after surgery between both groups
NRS pain score at 48 hours	Up to 48 hours after block procedure	To compare the NRS (0-10) pain score up to 48 hours
Self-reported satisfaction score at 48 hours	48 hours after block procedure	To compare self-reported patient satisfaction up to 48 hours after surgery between both groups
pain-DETECT scores at 90 days	Up to 90 days after block procedure	To compare the "pain-DETECT" questionnaire scores prior to surgery (baseline) and 30 ± 7, 60 ± 7 and 90 ± 7 days after surgery between groups

Trial Locations

Locations (1)

The Ohio State University Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States