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Abstract
Introduction
Seeking effective multimodal analgesia and anesthetic regimen is the basis for the success of ERAS. Opioid-free anesthesia (OFA) is a multimodal anesthesia associating hypnotics, N-methyl-D-aspartate (NMDA) antagonists, local anesthetics, anti-inflammatory drugs and α-2 agonists. Although previous studies have confirmed that OFA is safe and feasible for VATS surgery, there is great heterogeneity in how to select and combine anti-harm drugs to replace opioids. We hypothesized that the reduced opioid use during and after surgery allowed by OFA compared with standard of care will be associated with a reduction of postoperative opioid-related adverse events and an improvement in the quality of rehabilitation of patients after partial VATS lung resection.
Methods/Analysis
The TEDOFA Study is a prospective double-blind, randomized, controlled clinical trial with a concealed allocation of patients scheduled to undergo elective partial VATS pneumonectomy 1:1 to receive either a standard anesthesia protocol or an OFA. A total of 146 patients were recruited in the study. Primary endpoint was the 15-item recovery quality scale (QoR-15) at 24 hours after surgery.
Ethics and Dissemination
This trial has been approved by the Institutional Review Board of Beijing Friendship Hospital of China Capital University. The TEDOFA trial study protocol was approved on 27 February 2023. The trial started recruiting patients after registered on the Chinese Clinical Trial Registry.
Trial Registration Number
ChiCTR2300069210; Pre-results.
Data Sharing Statement
Availability of data and materials: The datasets used or analyzed during the current study are available from the corresponding author on reasonable request.
Disclosure
The authors report no conflicts of interest in this work.