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NCT05999721
The Effect of Superficial Parasternal Intercostal Plane Block on Pulmonary Function Tests After Cardiac Surgery
Conditions: Postoperative Pain, Pulmonary Function Tests
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 100
Sponsor: Shai Fein
Location: Rabin Medical Center, Beilinson Hospital Petah Tikva
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 Criteria
Inclusion criteria:
* 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 criteria:
* 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).
Criteria For Discontinuing (Postoperative Exclusion Criteria):
* 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).
* Patients requiring mechanical ventilation for more than 24 hours postoperatively.
Source: ClinicalTrials.gov (NCT05999721). StuddyBuddy aggregates publicly available trial information.