NCT04908449

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Coronary Artery Disease
• Postoperative Pain
• Respiratory Failure

Interventions

Type	Name	Description
DRUG	Rectus sheath block with bupivacaine	Rectus sheath block with local anesthetic versus sham block with saline

Timeline

• Start date: 2023-06-19
• Primary completion: 2024-11-08
• Completion: 2024-11-14
• First posted: 2021-06-01
• Last updated: 2025-11-17
• Results posted: 2025-11-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study