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.

Overview

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.

Interventions

• Procedure superficial parasternal intercostal plane block
  Injection of 60 mL of bupivacaine 0.25% and epinephrine 2.5 µg mL-1
• Other Standard care
  Operating Room: Anaesthesia will be induced using midazolam (0.1-0.15 mg kg-1), fentanyl (5-10 μg kg-1), and rocuronium (0.6-1.2 mg kg-1); then, after tracheal intubation, anaesthesia will be maintained using isoflurane at one MAC, along with continuous fentanyl (3-5 μg kg-1 h-1) and midazolam (20-50 μg kg-1 h-1). Additional boluses of fentanyl will be administered according to the anesthesiologist's discretion. Cardiothoracic Intensive Care Unit: Continuous fentanyl will be maintained until

Primary outcome measures

• Percentage Change in Forced Expiratory Volume in the First Second (FEV1) [Time frame: Baseline (preoperative) and first postoperative day]
• Percentage Change in Forced Vital Capacity (FVC) [Time frame: Baseline (preoperative) and first postoperative day]
• Percentage Change in Peak Expiratory Flow (PEF) [Time frame: Baseline (preoperative) and first postoperative day]

Secondary outcome measures (5)

• Pain scores, measured by Numeric Rating Scale (NRS) [Time frame: 0-8 hours, 8-16 hours, 16-24 hours, 24-48 hours, and 48-72 hours postoperatively]
• Opioid consumption, measured in Morphine Milligram Equivalents (MME) [Time frame: 0-8 hours, 8-16 hours, 16-24 hours, 24-48 hours, and 48-72 hours postoperatively]
• Postoperative pulmonary complication, based on the European perioperative clinical outcome (EPCO) criteria [Time frame: 30 days]
• Length of stay [Time frame: 30 days]
• Mortality [Time frame: 30 days]

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

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Supportive care

Study locations

Israel · 2 centers

• Rabin Medical Center, Beilinson Hospital — Petah Tikva
• Rabin Medical Center — Petah Tikva

Identifiers

NCT: NCT05999721 · 0577-23-RMC

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗