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

Postoperative Pain Clinical Trial

Official title: The Effect of Superficial Parasternal Intercostal Plane Block on Pulmonary Function Tests After Cardiac Surgery (PIPACS Trial): a Prospective, Double-blind, Randomised Controlled Trial.

Status Not yet recruiting

Clinical Trial 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?

Clinical Trial Description

Postoperative pulmonary complications pose a significant concern after cardiac surgery. Post-sternotomy pain plays a key role in impaired pulmonary function tests, ultimately increasing the risk of postoperative pulmonary complications. Parasternal intercostal plane blocks have recently emerged as a promising analgesic modality for cardiac surgery. However, the impact of parasternal intercostal plane blocks on pulmonary function tests remains unexplored.

In this prospective, single-centre, double-blind, randomised controlled trial, a total of 100 participants undergoing elective cardiac surgery will be recruited. Prior to surgery, baseline pulmonary function tests will be measured. Throughout the surgical procedure, all participants will receive identical anaesthesia and surgical protocols. At the end of the surgery and after sternal wound closure, participants will be randomly assigned to one of two research arms in a 1:1 ratio. The treatment arm will receive a superficial parasternal intercostal plane block in addition to standard care, while the control arm will receive standard care alone. Pulmonary function tests, pain scores, and opioid consumption will be recorded daily until the third postoperative day. The primary outcome is the difference between pre and postoperative PFTs values. Secondary outcomes are pain scores, opioid consumption, the incidence of postoperative pulmonary complications during current hospitalisation, cardiothoracic intensive care unit, hospital length stay, and 30-day mortality.

Pulmonary function tests were selected as the primary outcome due to their practicality and relevance to the postoperative course. The superficial parasternal intercostal plane block was chosen as the study intervention due to its simplicity and feasibility. The hypothesis posits that the addition of this intervention to standard care compared to standard care alone results in a smaller decrease in pulmonary function tests. ;

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

• NCT number: NCT05999721
• Study type: Interventional
• Source: Rabin Medical Center
• Contact: Shai Fein, MD, MHA
• Phone: +972 52 8989630
• Email: shaifein812@gmail.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Completion date: July 1, 2025