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一项评价全身麻醉下眼眶骨折重建术中无阿片类镇痛与节约阿片类镇痛的随机对照非劣效性试验

 

Authors Zhang R, Mai Y, Ye H, Lian X, Yang H, Zhu Y, Gan X 

Received 17 August 2024

Accepted for publication 6 November 2024

Published 11 November 2024 Volume 2024:17 Pages 3707—3717

DOI https://doi.org/10.2147/JPR.S491994

Checked for plagiarism Yes

Review by Single anonymous peer review

Peer reviewer comments 2

Editor who approved publication: Dr Karina Gritsenko

Rui Zhang,1,* Yongjian Mai,1,* Huijing Ye,2,* Xiufen Lian,2 Huasheng Yang,2 Yanling Zhu,1 Xiaoliang Gan1 

1Department of Anesthesiology, State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Ophthalmology Visual Science, Guangdong Provincial Clinical Research Center for Ocular Diseases, Guangzhou, 510060, People’s Republic of China; 2Department of Orbital Diseases and Ocular Oncology, State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Ophthalmology Visual Science, Guangdong Provincial Clinical Research Center for Ocular Diseases, Guangzhou, 510060, People’s Republic of China

*These authors contributed equally to this work

Correspondence: Xiaoliang Gan; Yanling Zhu, Email ganxl@mail.sysu.edu.cn; zhuyling8@mail.sysu.edu.cn

Background and Objectives: Opioid-minimizing strategies are making their appearance in enhanced recovery after surgery. This study is aimed to explore the potential advantages of opioid-free analgesia (OFA) compared to opioid-sparing analgesia (OSA) in patients undergoing orbital fracture reconstruction.
Methods: In this prospective, single-center, randomized controlled study, we randomly recruited 122 patients undergoing orbital fracture reconstruction under general anesthesia. Patients received total intravenous anesthesia with a flexible laryngeal mask airway, and multimodal analgesia with either OSA or OFA methods. The OSA group (n = 61) received low doses of fentanyl and nonsteroidal anti-inflammatory drugs (NSAIDs), and the OFA group (n = 61) received medial canthus peribulbar block (MCPB) combined with NSAIDs. The primary outcomes consisted of area-under-the-curve (AUC) of the numerical rating scale (NRS) pain score, and the incidence of postoperative nausea and vomiting (PONV) through the first 24h.
Results: Compared to the OSA group, the OFA group demonstrated non-inferiority in postoperative analgesia through the first 24 postoperative hours (difference of the medians, − 6; 95% confidence interval [CI], − 12 to 6), but failed to meet the non-inferiority criterion in the incidence of PONV (difference ratio, 3%; 95% CI, − 7% to 14%). The Quality of Recovery-40 questionnaire (QoR-40) scores on postoperative day 1 was significantly higher in group OFA compared to group OSA (188 [178 to 196] vs 181 [169 to 191], respectively; P = 0.005).
Conclusion: In orbital fracture reconstruction, both OFA and OSA strategies provide effective postoperative pain relief, but OFA using MCPB combined NSAIDs enhances the quality of early postoperative recovery.
Registered: Chinese Clinical Trial Registry ChiCTR1900028088.

Keywords: peribulbar block, opioid-free, opioid-sparing, analgesia, orbital fracture reconstruction