Recruiting

PIFB BlockSternotomy PIFB Block in Open Heart Surgery

Sponsor:

Ohio State University

Code:

NCT06233318

Conditions

Autonomic Nerve Block

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pecto-intercostal Fascial Block with 20 ml of 0.35% ropivacaine

Pecto-intercostal Fascial Block with normal saline

Study Details

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.

Conditions

Autonomic Nerve Block

Study ID

NCT06233318

Start date

Oct 16, 2023

Status verified date

Jun, 2026

Completion date

Jan 31, 2029

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

84 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Pecto-intercostal fascial block

Pecto-intercostal Fascial Block with 20 ml of 0.35% ropivacaine injected to each side under ultrasound visualization.

placebo comparator: Placebo

Pecto-intercostal Fascial Block with 20ml of normal saline injected to each side under ultrasound visualization.

Interventions

Pecto-intercostal Fascial Block with 20 ml of 0.35% ropivacaine

The US probe will be placed at sagittal plane, 2 cm lateral to the midline of the sternum to identify the second to the fifth costal cartilage from the ribs. Consequently, the US probe will be positioned in the space between the fourth and fifth costal cartilages at the sternum. After identifying the fascial planes of the chest wall, the pectoralis major muscle (PMM), the external intercostal muscle (EIM), the costal cartilage, the pleura, and the lungs. A sterile 22G blunt Stimuplex, 50 mm needle (B. Braun, Bethlehem, Pa) will be advanced and placed under the PMM and above the EIM. Following negative aspiration, PN solution with investigational product according to group randomization/allocation will be injected at each side in 5 mL aliquots ensuring appropriate spread of the PN solution. The separation of the fascial plane and the spread of the drug will be observed on the ultrasound image in real time.

Pecto-intercostal Fascial Block with normal saline

Primary outcome measure

OPIOID consumption at 24 hours [ Time Frame: 24 hours after block procedure ]
OPIOID consumption during surgery [ Time Frame: Surgery length ]
NRS pain score at 48 hours [ Time Frame: Up to 48 hours after block procedure ]
Worst pain score at 48 hours [ Time Frame: Up to 48 hours after block procedure ]
Incidence nausea and/or vomiting after surgery [ Time Frame: Up to 48 hours after block procedure ]
Self-reported satisfaction score at 48 hours [ Time Frame: 48 hours after block procedure ]
pain-DETECT scores at 90 days [ Time Frame: Up to 90 days after block procedure ]

Central Contacts and Locations

Central contacts

Alberto A Uribe

6142930775 alberto.uribe@osumc.edu

Jeremy Reeves

6142933559 jeremy.reeves@osumc.edu

Locations

The Ohio State University Wexner Medical Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Alberto A Uribe

6142930775 alberto.uribe@osumc.edu

Jeremy Reeves

6142933559 jeremy.reeves@osumc.edu

More Information

Sponsor

Ohio State University

Last update posted

Jul 9, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University on 2026-07-09.