Phase 1 N=62 Randomized Quadruple-blind Treatment

Pectointercostal Fascial Plane Block (PIFB) Alone Versus PIFB With Rectus Sheath Block (RSB) in Cardiac Surgery

Coronary Artery Disease · Postoperative Pain · Respiratory Failure

Bottom Line

View on ClinicalTrials.gov: NCT04908449 ↗

Enrolled (actual)

Serious AEs

1.6%

Results posted

Nov 2025

Primary outcome: Primary: Pain Scores at Rest Within the First 24 Hours After Extubation — 79.25; 102 Numeric rating score * hours.

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Rectus sheath block with bupivacaine (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Medical College of Wisconsin
Primary completion: Nov 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Pain Scores at Rest Within the First 24 Hours After Extubation	79.25; 102	—
PRIMARY Pain Scores With Deep Breathing Within the First 24 Hours After Extubation	141.5; 144	—
PRIMARY Total Cumulative Opioid Consumption	96.75; 95	—
PRIMARY Total Cumulative Opioid Consumption	96.75; 95	—
SECONDARY Time From ICU Arrival to Liberation From Mechanical Ventilation	3.87; 3.87	—
SECONDARY Vital Capacity Change From Baseline on Incentive Spirometry	.32; .30	—
SECONDARY Vital Capacity Change From Baseline on Incentive Spirometry	.32; .30	—
SECONDARY Vital Capacity Change From Baseline on Incentive Spirometry	.32; .30	—
SECONDARY Vital Capacity Change From Baseline on Incentive Spirometry	.32; .30	—
SECONDARY QoR-15 (Quality of Recovery) Score	83; 79.5	—
SECONDARY ICU Length of Stay	20.69; 25.77	—
SECONDARY Hospital Length of Stay	97.21; 97.31	—

Summary

The purpose of this study is to determine if ultrasound-guided bilateral pectointercostal fascial plane blocks with bilateral rectus sheath blocks block decrease pain scores, decrease opioid consumption, improve respiratory function, and improve quality of recovery in patients recovering from elective cardiac surgery involving primary median sternotomy and mediastinal chest tubes in comparison to pectointercostal fascial plane blocks alone.

Eligibility Criteria

Inclusion Criteria

Subjects scheduled for cardiac surgery involving primary median sternotomy and mediastinal chest tubes.
Age 18-85 years of age
BMI 18-50 kg/m2
Weight > 60 kg

Exclusion Criteria

Left ventricular ejection fraction (LVEF) 20 mg) in the past three months
Severe pulmonary or hepatic disease
Neurological deficit or disorder
Suspected or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past two years
Uncontrolled anxiety, schizophrenia, or other severe psychiatric disorder

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04908449). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.