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

NCT04908449 | Completed Phase 1 Results FDA Drug

• 1 other identifier: PRO00040365
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease; Postoperative Pain; Respiratory Failure

Keywords

local anesthetic; regional anesthesia; quality of recovery; postoperative pain; coronary artery bypass graft

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• Time From ICU Arrival to Liberation From Mechanical Ventilation

  ICU arrival until extubation

• Vital Capacity Change From Baseline on Incentive Spirometry

  1 hour post-extubation

• Vital Capacity Change From Baseline on Incentive Spirometry

  3 hours post-extubation

• Vital Capacity Change From Baseline on Incentive Spirometry

  12 hours post-extubation

• Vital Capacity Change From Baseline on Incentive Spirometry

  24 hours post-extubation

Study Arms (2)

Rectus sheath block block with PIFB (experimental arm)

EXPERIMENTAL

PIFB with local anesthetic with RSB with local anesthetic (bupivacaine)

Drug: Rectus sheath block with bupivacaine

Rectus sheath block with PIFB (placebo arm)

PLACEBO COMPARATOR

PIFB with local anesthetic with RSB placebo (saline)

Drug: Rectus sheath block with bupivacaine

Interventions

Rectus sheath block with bupivacaine DRUG

Rectus sheath block with local anesthetic versus sham block with saline

Also known as: Rectus sheath block with saline placebo

Rectus sheath block block with PIFB (experimental arm); Rectus sheath block with PIFB (placebo arm)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease; Pain, Postoperative; Respiratory Insufficiency

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr. Anne L. Castro
• Organization: Medical College of Wisconsin

anncastro@mcw.edu

(414) 805-8700

Study Officials

• Anne Castro

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology

Study Record Dates

• First Submitted: May 24, 2021
• First Posted: June 1, 2021
• Study Start: June 19, 2023
• Primary Completion: November 8, 2024
• Study Completion: November 14, 2024
• Last Updated: November 17, 2025
• Results First Posted: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)