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

NCT05999721 | Recruiting

• 1 other identifier: 0577-23-RMC
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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?

Conditions

Postoperative Pain; Pulmonary Function Tests

Keywords

Superficial Parasternal Intercostal Plane Block; Pulmonary function tests; Cardiac surgery

Outcome Measures

Primary Outcomes (3)

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

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

  Baseline (preoperative) and first postoperative day

• Percentage Change in Forced Vital Capacity (FVC)

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

  Baseline (preoperative) and first postoperative day

• Percentage Change in Peak Expiratory Flow (PEF)

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

  Baseline (preoperative) and first postoperative day

Secondary Outcomes (5)

• Pain scores, measured by Numeric Rating Scale (NRS)

  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)

  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

  30 days

• Length of stay

  30 days

• Mortality

  30 days

Study Arms (2)

Treatment Arm

ACTIVE COMPARATOR

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; Other: Standard care

Control Arm

ACTIVE COMPARATOR

The control arm will receive standard care alone.

Other: Standard care

Interventions

superficial parasternal intercostal plane block PROCEDURE

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

Treatment Arm

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.

Control Arm; Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shai Fein: lead

Study Sites (2)

Rabin Medical Center, Beilinson Hospital

Petah Tikva, Israel

RECRUITING

Rabin Medical Center

Petah Tikva, Israel

NOT YET RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Shai Fein, MD, MHA

  Rabin Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shai Fein, MD, MHA

CONTACT

+972 52 8989630; shaifein812@gmail.com

Karam Azem, MD

CONTACT

+972 50 4705001; dr.azem.k@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Head of Department, Department of Anesthesia, Beilinson Hospital, Rabin Medical Centre, Petach Tikva, Israel.

Study Record Dates

• First Submitted: August 6, 2023
• First Posted: August 21, 2023
• Study Start: January 25, 2025
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IL (2)