Effects of paravertebral block on postoperative analgesia in children undergoing unilateral thoracotomy cardiac surgery with cardiopulmonary bypass: protocol for a randomised controlled trial.

Abstract

This study aims to determine whether paravertebral block (PVB) provides better postoperative analgesia, lower incidence of complications and faster recovery compared with local anaesthetic wound infiltration for school-aged children undergoing cardiac surgery with cardiopulmonary bypass via thoracotomy. This is a single-centre, randomised controlled trial. We will enrol 100 children aged 6-14 years with atrial or ventricular septal defects scheduled for thoracotomy cardiac surgery with cardiopulmonary bypass. The patients will be randomly assigned to the PVB group and the control group in a ratio of 1:1. After the surgery, we will conduct unilateral PVB with ropivacaine for patients in the PVB group, and local anaesthetic wound infiltration for patients in the control group. We will use the double-dummy design to ensure blinding. The patients will not be administered analgesics after returning to the PICU(paediatric intensive care unit). Their bedside nurse will monitor their pain condition. When the Faces Pain Scale-Revised (FPS-R) Pain Score is ≥4, sufentanil infusion will be started. The primary outcome will be total opioid consumption within 24 hours after surgery. Secondary outcomes will be (1) FPS-R Scores at 6 hours, 12 hours, 18 hours and 24 hours after surgery; (2) The rate of opioid treatment for remedial analgesia; (3) The first time of FPS-R Score is ≥4 postoperatively. Exploratory outcomes will be: (1) Length of postoperative mechanical ventilation, ICU stay and hospital stay; (2) The rate of postoperative nausea and vomiting and respiratory depression 24 hours after surgery. This study was approved by the Ethics Committee of the Chinese Academy of Medical Sciences, Fuwai Hospital (No 2023-2135) and PUMC. Written informed consent will be obtained from each patient or their legal representatives before enrolment. The results of this trial will be published in an international peer-reviewed scientific journal. Chinese Clinical Trial Registry (ChiCTR2400081773) Clinical Trial（NCT06312904）.