Effect of a specific nerve block on lung function after heart surgery
The Effect of Superficial Parasternal Intercostal Plane Block on Pulmonary Function Tests After Cardiac Surgery (PIPACS Trial): a Prospective, Double-blind, Randomised Controlled Trial.
This study is testing if a specific nerve block can help improve lung function and reduce pain in adults after heart surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rabin Medical Center Academic / other |
| Locations | 2 sites (Petah Tikva and 1 other locations) |
| Trial ID | NCT05999721 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older scheduled for elective cardiac surgery via sternotomy with a BMI between 20 and 40.
Not a fit: Patients with severe pulmonary disease, chronic pain conditions, or contraindications for regional analgesia may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved pulmonary function and reduced postoperative complications for patients undergoing cardiac surgery.
How similar studies have performed: While the use of nerve blocks in postoperative pain management is established, the specific impact of sPIP blocks on pulmonary function in cardiac surgery is a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Petah Tikva and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.