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Clinical Trial Summary

The purpose of this study is to determine if ultrasound-guided bilateral pectointercostal fascial plane blocks with unilateral serratus anterior plane block decrease pain scores, decrease opioid consumption, improve respiratory function, and improve quality of recovery in patients recovering from coronary artery bypass surgery (CABG) in comparison to pectointercostal fascial plane blocks alone.

Clinical Trial Description

This is a single center, prospective, randomized, controlled, double-blinded study. We anticipate recruitment of 50-60 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 + SAPB 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 Preoperative Management : Subjects will be randomized on the morning of surgery to receive bilateral PIFB and left SAPB with local anesthetic versus bilateral PIFB and left SAPB 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 20 mL of 0.25% bupivacaine with 5 mcg/ml of epinephrine, and left-sided SAPB will be performed with an additional 20 mL of 0.25% bupivacaine with 5 mcg/ml of epinephrine or placebo. 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, and QoR-15 (Quality of Recovery) score23 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 Design

Related Conditions & MeSH terms

NCT number NCT04908449
Study type Interventional
Source Medical College of Wisconsin
Contact Anne Castro, MD
Phone 414-805-2715
Email [email protected]
Status Not yet recruiting
Phase Phase 1
Start date July 2021
Completion date August 2022

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