The Effect of Superficial Parasternal Intercostal Plane Block on Pulmonary Function Tests After Cardiac Surgery
- Conditions
- Postoperative PainPulmonary Function Tests
- Interventions
- Procedure: superficial parasternal intercostal plane blockOther: Standard care
- Registration Number
- NCT05999721
- Lead Sponsor
- Shai Fein
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment Arm superficial parasternal intercostal plane block In addition to standard care, the treatment arm will receive an ultrasound-guided bilateral single-shot superficial parasternal intercostal plane block at two levels. Treatment Arm Standard care In addition to standard care, the treatment arm will receive an ultrasound-guided bilateral single-shot superficial parasternal intercostal plane block at two levels. Control Arm Standard care The control arm will receive standard care alone.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (2)
Rabin Medical Center, Beilinson Hospital
🇮🇱Petah Tikva, Israel
Rabin Medical Center
🇮🇱Petach Tikva, Israel