RecruitingNot ApplicableNCT05999721

The Effect of Superficial Parasternal Intercostal Plane Block on Pulmonary Function Tests After Cardiac Surgery

The Effect of Superficial Parasternal Intercostal Plane Block on Pulmonary Function Tests After Cardiac Surgery (PIPACS Trial): a Prospective, Double-blind, Randomised Controlled Trial.

Sponsor

Shai Fein

Enrollment

100 participants

Start Date

Jan 25, 2025

Study Type

INTERVENTIONAL

Conditions

Postoperative Pain Pulmonary Function Tests

Summary

In adult patients undergoing cardiac surgery, does adding an sPIP block to standard care compared to standard care alone result in a smaller decrease in PFTs?

Eligibility

Min Age: 18 Years

Inclusion Criteria4

Patients who are scheduled to undergo elective cardiac surgery via sternotomy (i.e., coronary artery bypass graft, valvular surgery, and combined surgery).
Body Mass Index (BMI) above 20 and below 40 kg m-2
Age above 18 years.
Eligible to sign informed consent.

Exclusion Criteria16

Change from scheduled morning surgery to a non-morning case or emergency surgery.
Redo surgery.
Off-pump surgeries.
Pregnancy.
Preoperative mechanical circulatory support (i.e., intra-aortic balloon pump, extracorporeal membrane oxygenation, ventricular assist devices).
Preoperative chronic pain (i.e., fibromyalgia, chronic neuropathic pain).
Contraindication for regional analgesia (i.e., known allergy to LA, skin lesions in the injection site).
Known allergy to one or more of the components of multimodal analgesia (i.e., opioids, paracetamol, tramadol, dipyrone).
Preexisting severe pulmonary disease (i.e., an obstructive lung disease with FEV1 below 49%, restrictive lung disease with FVC below 49%, pulmonary hypertension).
Patients requiring mechanical ventilation for more than 24 hours postoperatively.
Prolonged cardiopulmonary bypass (CPB) of more than three hours.
Transfusion of more than three units of blood products.
Severe coagulation disturbance requiring prothrombin complex concentrate or recombinant factor VII.
Left ventricular failure with vasoactive-inotropic score (VIS) at the end of the surgery of ≥ 20.
Right ventricular failure requires inhaled nitric oxide.
Need for mechanical circulatory support (i.e., intra-aortic balloon pump, extracorporeal membrane oxygenation).

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Interventions

PROCEDUREsuperficial parasternal intercostal plane block

Injection of 60 mL of bupivacaine 0.25% and epinephrine 2.5 µg mL-1

OTHERStandard care

Operating Room: Anaesthesia will be induced using midazolam (0.1-0.15 mg kg-1), fentanyl (5-10 μg kg-1), and rocuronium (0.6-1.2 mg kg-1); then, after tracheal intubation, anaesthesia will be maintained using isoflurane at one MAC, along with continuous fentanyl (3-5 μg kg-1 h-1) and midazolam (20-50 μg kg-1 h-1). Additional boluses of fentanyl will be administered according to the anesthesiologist's discretion. Cardiothoracic Intensive Care Unit: Continuous fentanyl will be maintained until tracheal extubation. All patients will receive intravenous multimodal analgesic drugs around the clock, including paracetamol 3 g day-1 and dipyrone 3 g day-1. If pain persists, rescue doses of either intravenous tramadol or morphine will be administered. Cardiothoracic ward: The analgesic protocol includes around-the-clock intravenous paracetamol 3 g day-1 and dipyrone 3 g day-1. If pain continues, rescue doses of oral oxycodone will be administered.