Status:
RECRUITING
The Effect of Superficial Parasternal Intercostal Plane Block on Pulmonary Function Tests After Cardiac Surgery
Lead Sponsor:
Shai Fein
Conditions:
Postoperative Pain
Pulmonary Function Tests
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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?
Detailed Description
Postoperative pulmonary complications are a significant concern after cardiac surgery, with post-sternotomy pain contributing to impaired pulmonary function and increased risk of these complications. ...
Eligibility Criteria
Inclusion
- 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:
- 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.
- 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).
Exclusion
Key Trial Info
Start Date :
January 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05999721
Start Date
January 25 2025
End Date
January 1 2026
Last Update
February 19 2025
Active Locations (2)
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1
Rabin Medical Center, Beilinson Hospital
Petah Tikva, Israel
2
Rabin Medical Center
Petah Tikva, Israel