Actively Recruiting
The Effect of Superficial Parasternal Intercostal Plane Block on Pulmonary Function Tests After Cardiac Surgery
Led by Shai Fein · Updated on 2025-02-19
100
Participants Needed
2
Research Sites
48 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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?
CONDITIONS
Official Title
The Effect of Superficial Parasternal Intercostal Plane Block on Pulmonary Function Tests After Cardiac Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients scheduled for elective cardiac surgery via sternotomy (coronary artery bypass graft, valvular surgery, or combined surgery)
- Body Mass Index (BMI) above 20 and below 40 kg/m²
- Age above 18 years
- Able to provide informed consent
You will not qualify if you...
- Surgery changed from scheduled morning to non-morning or emergency surgery
- Redo surgery
- Off-pump surgeries
- Pregnancy
- Preoperative mechanical circulatory support (e.g., intra-aortic balloon pump, extracorporeal membrane oxygenation, ventricular assist devices)
- Preoperative chronic pain conditions (e.g., fibromyalgia, chronic neuropathic pain)
- Contraindication for regional analgesia (e.g., allergy to local anesthetics, skin lesions at injection site)
- Known allergy to components of multimodal analgesia (opioids, paracetamol, tramadol, dipyrone)
- Severe preexisting pulmonary disease (obstructive lung disease with FEV1 below 49%, restrictive lung disease with FVC below 49%, pulmonary hypertension)
- Mechanical ventilation needed for more than 24 hours after surgery
- Prolonged cardiopulmonary bypass over three hours
- Transfusion of more than three units of blood products
- Severe coagulation problems requiring special treatments
- Left ventricular failure with high vasoactive-inotropic score (≥ 20) at surgery end
- Right ventricular failure requiring inhaled nitric oxide
- Need for mechanical circulatory support after surgery (e.g., intra-aortic balloon pump, extracorporeal membrane oxygenation)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Rabin Medical Center, Beilinson Hospital
Petah Tikva, Israel
Actively Recruiting
2
Rabin Medical Center
Petah Tikva, Israel
Not Yet Recruiting
Research Team
S
Shai Fein, MD, MHA
CONTACT
K
Karam Azem, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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