Clinical trial NCT05999721: The Effect of Superficial Parasternal Intercostal Plane Block on Pulmonary Function Tests After Cardiac Surgery
Official title: The Effect of Superficial Parasternal Intercostal Plane Block on Pulmonary Function Tests After Cardiac Surgery (PIPACS Trial): a Prospective, Double-blind, Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Pain
Pulmonary Function Tests
Keywords: Superficial Parasternal Intercostal Plane Block
Pulmonary function tests
Cardiac surgery
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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. Parasternal intercostal plane blocks have recently emerged as a promising analgesic option for cardiac surgery, but their impact on pulmonary function tests (PFTs) has yet to be evaluated.

This prospective, single-center, double-blind, randomized controlled trial will recruit 100 adult patients undergoing elective cardiac surgery. Baseline pulmonary function, including FEV1, FVC, and PEF, will be measured preoperatively and reassessed on the first postoperative day to evaluate the primary outcome: percentage change in PFT values. Secondary outcomes include pain scores, opioid consumption, incidence of postoperative pulmonary complications during hospitalization, duration of cardiothoracic intensive care and hospital stays, and 30-day mortality.

This study aims to determine whether adding a superficial parasternal intercostal plane (sPIP) block to standard care better preserves pulmonary function in adult patients undergoing elective cardiac surgery.

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).

Primary outcomes:
measure: Percentage Change in Forced Expiratory Volume in the First Second (FEV1)
timeFrame: Baseline (preoperative) and first postoperative day
measure: Percentage Change in Forced Vital Capacity (FVC)
timeFrame: Baseline (preoperative) and first postoperative day
measure: Percentage Change in Peak Expiratory Flow (PEF)
timeFrame: Baseline (preoperative) and first postoperative day
Secondary outcomes:
measure: Pain scores, measured by Numeric Rating Scale (NRS)
timeFrame: 0-8 hours, 8-16 hours, 16-24 hours, 24-48 hours, and 48-72 hours postoperatively
measure: Opioid consumption, measured in Morphine Milligram Equivalents (MME)
timeFrame: 0-8 hours, 8-16 hours, 16-24 hours, 24-48 hours, and 48-72 hours postoperatively
measure: Postoperative pulmonary complication, based on the European perioperative clinical outcome (EPCO) criteria
timeFrame: 30 days
measure: Length of stay
timeFrame: 30 days
measure: Mortality
timeFrame: 30 days
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Rabin Medical Center
city: Petah Tikva
country: Israel
facility: Rabin Medical Center, Beilinson Hospital
Study officials:
affiliation: Rabin Medical Center
name: Shai Fein, MD, MHA
role: PRINCIPAL_INVESTIGATOR
References: