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

The Effect of Superficial Parasternal Intercostal Plane Block on Pulmonary Function Tests After Cardiac Surgery (PIPACS Trial): a Prospective, Double-blind, Randomised Controlled Trial.

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?

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Pain; Pulmonary Function Tests
• Intervention / Treatment: Procedure: superficial parasternal intercostal plane block; Other: Standard care

Detailed Description

Postoperative pulmonary complications pose a significant concern after cardiac surgery. Post-sternotomy pain plays a key role in impaired pulmonary function tests, ultimately increasing the risk of postoperative pulmonary complications. Parasternal intercostal plane blocks have recently emerged as a promising analgesic modality for cardiac surgery. However, the impact of parasternal intercostal plane blocks on pulmonary function tests remains unexplored.

In this prospective, single-centre, double-blind, randomised controlled trial, a total of 100 participants undergoing elective cardiac surgery will be recruited. Prior to surgery, baseline pulmonary function tests will be measured. Throughout the surgical procedure, all participants will receive identical anaesthesia and surgical protocols. At the end of the surgery and after sternal wound closure, participants will be randomly assigned to one of two research arms in a 1:1 ratio. The treatment arm will receive a superficial parasternal intercostal plane block in addition to standard care, while the control arm will receive standard care alone. Pulmonary function tests, pain scores, and opioid consumption will be recorded daily until the third postoperative day. The primary outcome is the difference between pre and postoperative PFTs values. Secondary outcomes are pain scores, opioid consumption, the incidence of postoperative pulmonary complications during current hospitalisation, cardiothoracic intensive care unit, hospital length stay, and 30-day mortality.

Pulmonary function tests were selected as the primary outcome due to their practicality and relevance to the postoperative course. The superficial parasternal intercostal plane block was chosen as the study intervention due to its simplicity and feasibility. The hypothesis posits that the addition of this intervention to standard care compared to standard care alone results in a smaller decrease in pulmonary function tests.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shai Fein, MD, MHA; Phone Number: +972 52 8989630; Email: shaifein812@gmail.com
• Study Contact Backup: Name: Karam Azem, MD; Phone Number: +972 50 4705001; Email: dr.azem.k@gmail.com

Study Locations

• Israel
  • Petach Tikva, Israel
    • Rabin Medical Center
    • Contact: Shai Fein, MD, MHA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients who are scheduled to undergo elective cardiac surgery via sternotomy (i.e., coronary artery bypass graft, valve replacement, valve repair).
• Body Mass Index (BMI) above 20 and below 40 kg m-2.
• Age above 18 years.
• Eligible to sign informed consent.

Exclusion Criteria:

• 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, post-sternotomy pain syndrome, chronic neuropathic pain).
• Contraindication for regional analgesia (i.e., known allergy to local anaesthetics, 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment Arm; In addition to standard care, the treatment arm will receive an ultrasound-guided bilateral single-shot superficial parasternal intercostal plane block at two levels.	Procedure: superficial parasternal intercostal plane block; Injection of 60 mL of bupivacaine 0.25% and epinephrine 2.5 µg mL-1; Other: Standard care; 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). Moreover, patients will receive intravenous multimodal analgesics, including paracetamol 1 g, tramadol 100 mg, and dipyrone 1 g. In the cardiothoracic intensive care unit, anaesthesia will be maintained using continuous fentanyl (2-5 μg kg-1) until tracheal extubation. After tracheal extubation, patients will receive intravenous multimodal analgesic drugs around the clock, including paracetamol 3 g day-1, tramadol 300 mg day-1, and dipyrone 3 g day-1. If the patients are still in pain, rescue doses of intravenous morphine 5 mg will be administered.
Active Comparator: Control Arm; The control arm will receive standard care alone.	Other: Standard care; 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). Moreover, patients will receive intravenous multimodal analgesics, including paracetamol 1 g, tramadol 100 mg, and dipyrone 1 g. In the cardiothoracic intensive care unit, anaesthesia will be maintained using continuous fentanyl (2-5 μg kg-1) until tracheal extubation. After tracheal extubation, patients will receive intravenous multimodal analgesic drugs around the clock, including paracetamol 3 g day-1, tramadol 300 mg day-1, and dipyrone 3 g day-1. If the patients are still in pain, rescue doses of intravenous morphine 5 mg will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak expiratory flow rates (PEFR), measured in liters per second	The difference between daily PEFR measurements until the third postoperative day compared to baseline values	72 hours
Forced expiratory volume in the first second (FEV1), measured in liters	The difference between daily FEV1 measurements until the third postoperative day compared to baseline values	72 hours
Forced vital capacity (FVC), measured in liters	The difference between daily FVC measurements until the third postoperative day compared to baseline values	72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain scores, measured by visual numeric scale (VNS)	Daily VNS scores measurment until the third postoperative day	72 hours
Opioid consumption, measured in morphine milligram equivalence (MME)	Daily MME measurment until the third postoperative day	72 hours
Postoperative pulmonary complication, based on the European perioperative clinical outcome (EPCO) criteria	The incidence of postoperative pulmonary complications during current hospitalisation	30 days
Length of stay	The length of cardiothoracic intensive care unit and hospital stay	30 days
Mortality	Thirty-day mortality	30 days

Collaborators and Investigators

• Sponsor: Shai Fein
• Investigators: Principal Investigator: Shai Fein, MD, MHA, Rabin Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): May 31, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: August 6, 2023
• First Submitted That Met QC Criteria: August 17, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Cardiac surgery; Pulmonary function tests; Superficial Parasternal Intercostal Plane Block
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 0577-23-RMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Participant-level datasets and statistical code will be provided upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No