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

NCT ID: NCT05999721

Last Updated: 2025-02-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-25
• Study Completion Date: 2026-01-01

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.

Conditions

Postoperative Pain; Pulmonary Function Tests

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

superficial parasternal intercostal plane block

Intervention Type: PROCEDURE

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

Standard care

Intervention Type: 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.

Control Arm

The control arm will receive standard care alone.

Group Type: ACTIVE_COMPARATOR

Standard care

Intervention Type: 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.

Interventions

superficial parasternal intercostal plane block

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

Intervention Type: PROCEDURE

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 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.

Intervention Type: OTHER

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.

• 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shai Fein

OTHER

Sponsor Role: lead

Responsible Party

Shai Fein

Principal Investigator, Head of Department, Department of Anesthesia, Beilinson Hospital, Rabin Medical Centre, Petach Tikva, Israel.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Shai Fein, MD, MHA

Role: PRINCIPAL_INVESTIGATOR

Rabin Medical Center

Locations

Rabin Medical Center, Beilinson Hospital

Petah Tikva, , Israel

Site Status: RECRUITING

Rabin Medical Center

Petah Tikva, , Israel

Site Status: NOT_YET_RECRUITING

Countries

Israel

Central Contacts

Shai Fein, MD, MHA

Role: CONTACT

shaifein812@gmail.com

+972 52 8989630

Karam Azem, MD

Role: CONTACT

dr.azem.k@gmail.com

+972 50 4705001

Facility Contacts

Shai Fein, MD, MHA

Role: primary

Other Identifiers

0577-23-RMC

Identifier Type: -

Identifier Source: org_study_id