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TEDOFA 试验研究方案:一项前瞻性双盲、随机、对照临床试验,比较无阿片麻醉与阿片麻醉对接受胸腔镜手术的患者术后恢复质量和慢性疼痛的影响
Authors Song B, Li X, Yang J, Li W, Wan L
Received 7 November 2023
Accepted for publication 5 February 2024
Published 12 February 2024 Volume 2024:17 Pages 635—642
DOI https://doi.org/10.2147/JPR.S438733
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Dr Timothy Atkinson
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.
Keywords: opioid-free anesthesia, thoracoscopic surgery, postoperative recovery, chronic pain