Effect of a specific nerve block on lung function after heart surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the impact of a superficial parasternal intercostal plane (sPIP) block on pulmonary function tests (PFTs) in adult patients undergoing elective cardiac surgery. It aims to determine if adding this nerve block to standard postoperative care can reduce the decline in lung function typically observed after such surgeries. The study will measure baseline pulmonary function preoperatively and reassess it on the first postoperative day, alongside secondary outcomes like pain scores and opioid consumption. A total of 100 patients will be recruited for this double-blind, randomized controlled trial at a single center.

Why it matters

Who can join: the full rules

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.

Where it's running

• Rabin Medical Center, Beilinson Hospital
  Petah Tikva, Israel Recruiting
• Rabin Medical Center
  Petah Tikva, Israel Not yet recruiting

Study contacts

• Principal investigator: Shai Fein, MD, MHA — Rabin Medical Center
• Study coordinator: Shai Fein, MD, MHA
• Email: shaifein812@gmail.com
• Phone: +972 52 8989630

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.