Postoperative Pain, Pulmonary Function Tests
Conditions
Keywords
Superficial Parasternal Intercostal Plane Block, Pulmonary function tests, Cardiac surgery
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.
Interventions
Injection of 60 mL of bupivacaine 0.25% and epinephrine 2.5 µg mL-1
OTHERStandard 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.
Sponsors
Shai Fein
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change in Forced Expiratory Volume in the First Second (FEV1) | Baseline (preoperative) and first postoperative day | Percentage change in FEV1 (measured in litres) from baseline to the first postoperative day. |
| Percentage Change in Forced Vital Capacity (FVC) | Baseline (preoperative) and first postoperative day | Percentage change in FVC (measured in litres) from baseline to the first postoperative day. |
| Percentage Change in Peak Expiratory Flow (PEF) | Baseline (preoperative) and first postoperative day | Percentage change in PEF (measured in litres per second) from baseline to the first postoperative day. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Maximum pain NRS (0-10) recorded at various time intervals. |
| 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 | Opioid consumption measured in MME at various time intervals postoperatively. |
| Postoperative pulmonary complication, based on the European perioperative clinical outcome (EPCO) criteria | 30 days | The incidence of postoperative pulmonary complications during current hospitalisation |
| Length of stay | 30 days | The length of cardiothoracic intensive care unit and hospital stay |
| Mortality | 30 days | Thirty-day mortality |
Countries
Israel
Contacts
CONTACTShai Fein, MD, MHA
CONTACTKaram Azem, MD
PRINCIPAL_INVESTIGATORShai Fein, MD, MHA
Rabin Medical Center
Outcome results
None listed