Phase 1
Completed N=62
Pectointercostal Fascial Plane Block (PIFB) Alone Versus PIFB With Rectus Sheath Block (RSB) in Cardiac Surgery
Source: ClinicalTrials.gov NCT04908449 ↗Enrolled (actual)
62
Serious AEs
1.6%
Results posted
Nov 2025
Primary outcomePrimary: Pain Scores at Rest Within the First 24 Hours After Extubation — 79.25; 102 Numeric rating score * hours.
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.
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 | — |
| 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 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 | — |
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
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. Informational only — not medical advice.