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NCT Number: NCT05999721

The Effect of Superficial Parasternal Intercostal Plane Block on Pulmonary Function Tests After Cardiac Surgery

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?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rabin Medical Center, Petah Tikva, Israel

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

superficial parasternal intercostal Plane block

Procedure

Injection of 60 mL of bupivacaine 0.25% and epinephrine 2.5 µg mL-1

Standard care

Other

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 tracheal extubation. All patients will receive intravenous multimodal analgesic drugs around the clock, including paracetamol 3 g day-1 and dipyrone 3 g day-1. If pain persists, rescue doses of either intravenous tramadol or morphine will be administered.

Cardiothoracic ward:

The analgesic protocol includes around-the-clock intravenous paracetamol 3 g day-1 and dipyrone 3 g day-1. If pain continues, rescue doses of oral oxycodone will be administered.

Primary outcomes

  1. Percentage Change in Forced Expiratory Volume in the First Second (FEV1)

    Time frame: Baseline (preoperative) and first postoperative day

    Percentage change in FEV1 (measured in litres) from baseline to the first postoperative day.

  2. Percentage Change in Forced Vital Capacity (FVC)

    Time frame: Baseline (preoperative) and first postoperative day

    Percentage change in FVC (measured in litres) from baseline to the first postoperative day.

  3. Percentage Change in Peak Expiratory Flow (PEF)

    Time frame: Baseline (preoperative) and first postoperative day

    Percentage change in PEF (measured in litres per second) from baseline to the first postoperative day.

Secondary outcomes

  1. 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

    Maximum pain NRS (0-10) recorded at various time intervals.

  2. 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

    Opioid consumption measured in MME at various time intervals postoperatively.

  3. Postoperative pulmonary complication, based on the European perioperative clinical outcome (EPCO) criteria

    Time frame: 30 days

    The incidence of postoperative pulmonary complications during current hospitalisation

  4. Length of stay

    Time frame: 30 days

    The length of cardiothoracic intensive care unit and hospital stay

  5. Mortality

    Time frame: 30 days

    Thirty-day mortality

Study contacts

Contact information is provided by the study sponsor or research team.

Karam Azem, MD

CONTACT

[email protected]

+972 50 4705001

Shai Fein, MD, MHA

CONTACT

[email protected]

+972 52 8989630

Sponsors and collaborators

Lead sponsor

Shai Fein

Other

Registry information

Official study 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.

Acronym: PIPACS

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 21, 2023
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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