Efficacy and safety of paravertebral blockade in paediatric cardiothoracic surgery: a protocol for systematic review and meta-analysis.

Abstract

Paravertebral blockade (PVB) is a regional anaesthesia technique increasingly used in paediatric cardiothoracic surgery for postoperative pain management. However, its comparative efficacy and safety relative to other analgesic strategies remain inadequately synthesised. This systematic review aims to evaluate the effectiveness, safety and complications of PVB in paediatric patients undergoing cardiothoracic surgery. This protocol adheres to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines. We will search MEDLINE, EMBASE, Cochrane Library, Web of Science, Scopus, ClinicalTrials.gov and other relevant sources from inception to February 2025. Randomised controlled trials (RCTs) comparing PVB with systemic opioids, epidural analgesia or placebo in patients aged <18 years will be included. Exclusion criteria include non-RCTs, adult populations and non-cardiothoracic surgeries. Primary outcomes include postoperative pain intensity measured using validated scales such as Face, Legs, Activity, Cry, Consolability Scale or Numeric Rating Scale within 24-48 hours. Secondary outcomes include opioid consumption within 24-48 hours, length of hospital stay, haemodynamic stability and complications (eg, pneumothorax, local anaesthetic toxicity). Two reviewers will independently screen studies, extract data and assess the risk of bias using the Cochrane Risk of Bias-2 tool. A meta-analysis using a random-effects model or a narrative synthesis will be conducted based on heterogeneity (<i>I</i>²≥75%). Subgroup analyses will explore variations by age group, surgical type and PVB technique. As this study involves secondary analysis of existing data, ethical approval is not required. The completed review will be submitted for open-access publication in a peer-reviewed journal to ensure accessibility for clinicians, researchers and policymakers. CRD42025644837.