The Effect of Superficial Parasternal Intercostal Plane Block on Pulmonary Function Tests After Cardiac Surgery (PIPACS Trial): a Prospective, Double-blind, Randomised Controlled Trial.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Postoperative Pain
- Sponsor
- Shai Fein
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Percentage Change in Forced Expiratory Volume in the First Second (FEV1)
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Shai Fein
Principal Investigator, Head of Department, Department of Anesthesia, Beilinson Hospital, Rabin Medical Centre, Petach Tikva, Israel.
Rabin Medical Center
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Percentage Change in Forced Expiratory Volume in the First Second (FEV1)
Time Frame: 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)
Time Frame: 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)
Time Frame: Baseline (preoperative) and first postoperative day
Percentage change in PEF (measured in litres per second) from baseline to the first postoperative day.
Secondary Outcomes
- 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)