An interventional study of superficial parasternal intercostal plane block and Standard care in Postoperative Pain and Pulmonary Function Tests, sponsored by Shai Fein. Recruiting at 2 sites in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-09.
Sponsored by Shai Fein · Not applicable, Interventional, and Supportive care
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?
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.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's planned enrollment of 100 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →This is the only study on the registry with Shai Fein as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Criteria For Discontinuing (Postoperative Exclusion Criteria):
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
The control arm will receive standard care alone.
Other: Standard care
Injection of 60 mL of bupivacaine 0.25% and epinephrine 2.5 µg mL-1
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (preoperative) and first postoperative day
Pain scores, measured by Numeric Rating Scale (NRS)
Maximum pain NRS (0-10) recorded at various time intervals.
Time frame: 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)
Opioid consumption measured in MME at various time intervals postoperatively.
Time frame: 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
The incidence of postoperative pulmonary complications during current hospitalisation
Time frame: 30 days
Length of stay
The length of cardiothoracic intensive care unit and hospital stay
Time frame: 30 days
Mortality
Thirty-day mortality
Time frame: 30 days
Plan to share: No — Participant-level datasets and statistical code will be provided upon request.
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