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

A Comparison of the Analgesic Effects of Pectointercostal Fascial Plane Block (PIFB) Alone Versus PIFB With Rectus Sheath Block (RSB) in Cardiac Surgery: a Prospective, Randomized Controlled Trial.

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Postoperative Pain; Respiratory Failure
• Intervention / Treatment: Drug: Rectus sheath block with bupivacaine

Detailed Description

This is a single center, prospective, randomized, controlled, double-blinded study. We anticipate recruitment of 62 subjects, with 25-30 in each group.

Primary Outcomes:

Pain scores on a 0-10 visual analog scale (VAS) at rest and with deep breathing at 1, 3, 6, 12, 18, and 24 hours post-extubation between subjects receiving PIFB + RSB versus subjects receiving only PIFB.

Total cumulative opioid consumption at 24 and 48 hours post-operatively.

Secondary Outcomes:

• Intraoperative total opioid consumption
• Change from baseline on incentive spirometry at 1, 3, 12, and 24 hours post-extubation
• Time from ICU arrival to liberation from mechanical ventilation
• QoR-15 (Quality of Recovery) score23 24 hours after extubation
• Hospital and ICU length of stay

Preoperative Management :

Subjects will be randomized on the morning of surgery to receive bilateral PIFB and bilateral RSB with local anesthetic versus bilateral PIFB with local anesthetic and bilateral RSB with saline (placebo).

Intraoperative Management All subjects will receive the standard of care anesthetic regimen for their cardiac surgery.

Postoperative Management Each PIFB will be performed with 15 mL of 0.25% bupivacaine with 5 mcg/ml of epinephrine, and bilateral RSB will be performed with an additional 20 mL of 0.25% bupivacaine with 5 mcg/ml of epinephrine (10mL on each side).

Postoperative Evaluation:

Evaluation of acute postoperative pain intensity using a 0-10 visual analog scale (VAS) will be undertaken at the following time points, both at rest and with deep breathing:

• 1, 3, 6, 12, 18, and 24 hours post-extubation Incentive spirometry will be assessed at 1, 3, 12, and 24 hours post-extubation, with three measures taken at each time point in order to compare postoperative performance with baseline spirometry.

Review of the medical chart will be made post-operatively to gather other data, including total intraoperative oral morphine equivalent consumption, cumulative opioid consumption at 24 and 48 hours, time from ICU arrival to tracheal extubation, hospital and ICU length of stay, and QoR-15 (Quality of Recovery) score administered 24 hours after extubation (with margin of error of 18-30 hours to avoid waking patients in the middle of the night) . Occurrences of any adverse events reported by the subject or medical team will also be collected.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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) < 30%
• Preoperative, intraoperative, or immediate post-operative placement of intra-aortic balloon pump or deployment of extra-corporeal membrane oxygenation (ECMO)
• Inability to understand or speak English
• Allergy to bupivacaine or other amide local anesthetic
• Contraindication to peripheral nerve block (e.g. local infection, previous trauma to the block site)
• Chronic opioid consumption (daily oral morphine equivalent of >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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rectus sheath block block with PIFB (experimental arm); PIFB with local anesthetic with RSB with local anesthetic (bupivacaine)	Drug: Rectus sheath block with bupivacaine; Rectus sheath block with local anesthetic versus sham block with saline; Other Names: Rectus sheath block with saline placebo
Placebo Comparator: Rectus sheath block with PIFB (placebo arm); PIFB with local anesthetic with RSB placebo (saline)	Drug: Rectus sheath block with bupivacaine; Rectus sheath block with local anesthetic versus sham block with saline; Other Names: Rectus sheath block with saline placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Scores at Rest Within the First 24 Hours After Extubation	Measured by area under the curve (AUC) for pain scores gathered at 1, 3, 6, 12, 18, and 24 hours after extubation. To calculate the Area Under the Curve (AUC) for pain scores, pain intensity is plotted against time and the trapezoidal rule is used to approximate the area under the resulting curve. This AUC value represents the overall pain experience, considering both pain intensity and duration. Scale 0-240, with higher indicating a worse outcome. Units: Numeric rating score * hours.	24 hours after extubation
Pain Scores With Deep Breathing Within the First 24 Hours After Extubation	Measured by area under the curve (AUC) for pain scores gathered at 1, 3, 6, 12, 18, and 24 hours after extubation. To calculate the Area Under the Curve (AUC) for pain scores, pain intensity is plotted against time and the trapezoidal rule is used to approximate the area under the resulting curve. This AUC value represents the overall pain experience, considering both pain intensity and duration. Scale 0-240, with higher indicating a worse outcome. Units: Numeric rating score * hours.	24 hours after extubation
Total Cumulative Opioid Consumption	Total cumulative opioid consumption at 24 hours	24 hours post-operatively
Total Cumulative Opioid Consumption	Total cumulative opioid consumption at 48 hours	48 hours post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time From ICU Arrival to Liberation From Mechanical Ventilation	Time from ICU arrival as measured by "anesthesia stop" to liberation from mechanical ventilation (extubation).	ICU arrival until extubation
Vital Capacity Change From Baseline on Incentive Spirometry	Vital capacity change from baseline on incentive spirometry, measured as a percentage. An incentive spirometer was used to gather vital capacity (measured in mL).	1 hour post-extubation
Vital Capacity Change From Baseline on Incentive Spirometry	Vital capacity change from baseline on incentive spirometry, measured as a percentage. An incentive spirometer was used to gather vital capacity (measured in mL).	3 hours post-extubation
Vital Capacity Change From Baseline on Incentive Spirometry	Vital capacity change from baseline on incentive spirometry, measured as a percentage. An incentive spirometer was used to gather vital capacity (measured in mL).	12 hours post-extubation
Vital Capacity Change From Baseline on Incentive Spirometry	Vital capacity change from baseline on incentive spirometry, measured as a percentage. An incentive spirometer was used to gather vital capacity (measured in mL).	24 hours post-extubation
QoR-15 (Quality of Recovery) Score	QoR-15 (Quality of Recovery) score is a 15 question survey asking patients about various aspects of their quality of recovery, including pain control, nausea, anxiety, depression, ability to eat, etc. The scale is 0-150, with higher scores indicating a better outcome.	24 hours after extubation
ICU Length of Stay	ICU Length of Stay in hours, as measured by anesthesia stop until transfer out of the ICU.	Time from anesthesia stop to transfer out of ICU, typically 24 hours
Hospital Length of Stay	Hospital Length of Stay in hours, as measured by anesthesia stop until discharge from the hospital.	Time from anesthesia stop to hospital discharge, typically one week

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin
• Investigators: Principal Investigator: Anne Castro, Medical College of Wisconsin

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2023
• Primary Completion (Actual): November 8, 2024
• Study Completion (Actual): November 14, 2024

Study Registration Dates

• First Submitted: May 24, 2021
• First Submitted That Met QC Criteria: May 27, 2021
• First Posted (Actual): June 1, 2021

Study Record Updates

• Last Update Posted (Estimated): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 3, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: quality of recovery; coronary artery bypass graft; postoperative pain; regional anesthesia; local anesthetic
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Heart Diseases; Respiratory Tract Diseases; Respiration Disorders; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Respiratory Insufficiency; Coronary Artery Disease; Organic Chemicals; Anilides; Amides; Aniline Compounds; Amines; Bupivacaine
• Other Study ID Numbers: PRO00040365

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No