TEDOFA Trial Study Protocol: A Prospective Double-Blind, Randomized, Controlled Clinical Trial Comparing Opioid-Free versus Opioid Anesthesia on the Quality of Postoperative Recovery and Chronic Pain in Patients Receiving Thoracoscopic Surgery
Bijia Song, Xiuliang Li, Jiguang Yang, Wenjing Li, Lei Wan Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, Beijing, 100050, People’s Republic of ChinaCorrespondence: Lei Wan, Email wanleimz@sina.comIntroduction: Seeking effective multimodal analgesia and anesth...
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| Format: | Article |
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Dove Medical Press
2024-02-01
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| Series: | Journal of Pain Research |
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| Online Access: | https://www.dovepress.com/tedofa-trial-study-protocol-a-prospective-double-blind-randomized-cont-peer-reviewed-fulltext-article-JPR |
| _version_ | 1797311745383989248 |
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| author | Song B Li X Yang J Li W Wan L |
| author_facet | Song B Li X Yang J Li W Wan L |
| author_sort | Song B |
| collection | DOAJ |
| description | Bijia Song, Xiuliang Li, Jiguang Yang, Wenjing Li, Lei Wan Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, Beijing, 100050, People’s Republic of ChinaCorrespondence: Lei Wan, Email wanleimz@sina.comIntroduction: 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 |
| first_indexed | 2024-03-08T02:04:12Z |
| format | Article |
| id | doaj.art-cf065edbadc84521b7d88247d1c5c3f3 |
| institution | Directory Open Access Journal |
| issn | 1178-7090 |
| language | English |
| last_indexed | 2024-03-08T02:04:12Z |
| publishDate | 2024-02-01 |
| publisher | Dove Medical Press |
| record_format | Article |
| series | Journal of Pain Research |
| spelling | doaj.art-cf065edbadc84521b7d88247d1c5c3f32024-02-13T19:43:10ZengDove Medical PressJournal of Pain Research1178-70902024-02-01Volume 1763564290413TEDOFA Trial Study Protocol: A Prospective Double-Blind, Randomized, Controlled Clinical Trial Comparing Opioid-Free versus Opioid Anesthesia on the Quality of Postoperative Recovery and Chronic Pain in Patients Receiving Thoracoscopic SurgerySong BLi XYang JLi WWan LBijia Song, Xiuliang Li, Jiguang Yang, Wenjing Li, Lei Wan Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, Beijing, 100050, People’s Republic of ChinaCorrespondence: Lei Wan, Email wanleimz@sina.comIntroduction: 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 painhttps://www.dovepress.com/tedofa-trial-study-protocol-a-prospective-double-blind-randomized-cont-peer-reviewed-fulltext-article-JPRopioid-free anesthesiathoracoscopic surgerypostoperative recoverychronic pain |
| spellingShingle | Song B Li X Yang J Li W Wan L TEDOFA Trial Study Protocol: A Prospective Double-Blind, Randomized, Controlled Clinical Trial Comparing Opioid-Free versus Opioid Anesthesia on the Quality of Postoperative Recovery and Chronic Pain in Patients Receiving Thoracoscopic Surgery Journal of Pain Research opioid-free anesthesia thoracoscopic surgery postoperative recovery chronic pain |
| title | TEDOFA Trial Study Protocol: A Prospective Double-Blind, Randomized, Controlled Clinical Trial Comparing Opioid-Free versus Opioid Anesthesia on the Quality of Postoperative Recovery and Chronic Pain in Patients Receiving Thoracoscopic Surgery |
| title_full | TEDOFA Trial Study Protocol: A Prospective Double-Blind, Randomized, Controlled Clinical Trial Comparing Opioid-Free versus Opioid Anesthesia on the Quality of Postoperative Recovery and Chronic Pain in Patients Receiving Thoracoscopic Surgery |
| title_fullStr | TEDOFA Trial Study Protocol: A Prospective Double-Blind, Randomized, Controlled Clinical Trial Comparing Opioid-Free versus Opioid Anesthesia on the Quality of Postoperative Recovery and Chronic Pain in Patients Receiving Thoracoscopic Surgery |
| title_full_unstemmed | TEDOFA Trial Study Protocol: A Prospective Double-Blind, Randomized, Controlled Clinical Trial Comparing Opioid-Free versus Opioid Anesthesia on the Quality of Postoperative Recovery and Chronic Pain in Patients Receiving Thoracoscopic Surgery |
| title_short | TEDOFA Trial Study Protocol: A Prospective Double-Blind, Randomized, Controlled Clinical Trial Comparing Opioid-Free versus Opioid Anesthesia on the Quality of Postoperative Recovery and Chronic Pain in Patients Receiving Thoracoscopic Surgery |
| title_sort | tedofa trial study protocol a prospective double blind randomized controlled clinical trial comparing opioid free versus opioid anesthesia on the quality of postoperative recovery and chronic pain in patients receiving thoracoscopic surgery |
| topic | opioid-free anesthesia thoracoscopic surgery postoperative recovery chronic pain |
| url | https://www.dovepress.com/tedofa-trial-study-protocol-a-prospective-double-blind-randomized-cont-peer-reviewed-fulltext-article-JPR |
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