NCT05999721 The Effect of Superficial Parasternal Intercostal Plane Block on Pulmonary Function Tests After Cardiac Surgery
| NCT ID | NCT05999721 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shai Fein |
| Condition | Postoperative Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-01-25 |
| Primary Completion | 2025-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2025-01-25 with a primary completion date of 2025-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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?
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: * 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).
Contact & Investigator
Shai Fein, MD, MHA
PRINCIPAL INVESTIGATOR
Rabin Medical Center
Frequently Asked Questions
Who can join the NCT05999721 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Postoperative Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05999721 currently recruiting?
Yes, NCT05999721 is actively recruiting participants. Contact the research team at shaifein812@gmail.com for enrollment information.
Where is the NCT05999721 trial being conducted?
This trial is being conducted at Petah Tikva, Israel, Petah Tikva, Israel.
Who is sponsoring the NCT05999721 clinical trial?
NCT05999721 is sponsored by Shai Fein. The principal investigator is Shai Fein, MD, MHA at Rabin Medical Center. The trial plans to enroll 100 participants.