不同年龄患者胸腔镜肺手术后肋间神经阻滞时羟考酮用于急性术后疼痛的半数有效剂量：一项剂量探索研究方案
The median effective dose of oxycodone for acute postoperative pain after thoracoscopic pulmonary surgery with intercostal nerve blockin in patients of different ages: a dose-finding study protocol.
作者信息
Zhang Min, Liu Yi, Cao Jing, Liu Mengjie, Gao Xiaojun, Guo Na, Wei Chuansong, Zhu Ye, Sun Yongtao, Wu Jianbo
机构信息
Department of Anesthesiology, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, Jinan, 250014, China.
Shandong Institute of Anesthesia and Respiratory Critical Medicine, Jinan, 250014, China.
出版信息
BMC Anesthesiol. 2025 Jul 1;25(1):323. doi: 10.1186/s12871-025-03198-5.
BACKGROUND
Oxycodone is an effective drug for controlling acute postoperative pain (APP), especially visceral pain. However, the effective dose needed for controlling APP depends on the surgical method and the patient age. Therefore, through use of the Dixon up-and-down method, this study investigated the median effective dose (ED) of oxycodone that could be combined with intercostal nerve block (INB) to effectively control APP after thoracoscopic pulmonary surgery in patients of different ages.
METHODS
This is a prospective, interventional, dose-finding study. Patients undergoing thoracoscopic lobar and sublobar resections under general anaesthesia will be selected and divided into 4 groups according to age and surgical method: the elderly lobectomy group (aged ≥ 65 years), the nonelderly lobectomy group (aged < 65 years), the elderly sublobar resection group (aged ≥ 65 years), and the nonelderly sublobar resection group (aged < 65 years). The study will be performed simultaneously in four experimental groups via the Dixon up-and-down method. The initial dose for the first patient in each group will be set to 0.1 mg/kg; the dose for the next patient will be determined by the response of the previous patient. The primary outcome is the ED of oxycodone.
DISCUSSION
The results of this study are expected to provide an effective strategy for the management of APP following thoracoscopic pulmonary surgery and specifically to offer more accurate dose guidance for the use of oxycodone in older patients. This will not only improve the development of individualized pain management plans but also optimize the patient's postoperative recovery, reduce unnecessary drug side effects, and increase the overall comfort and quality of life of patients.
TRIAL REGISTRATION
This study was registered on clinicaltrials.gov (NCT06534801) on August 1, 2024.
背景
羟考酮是控制术后急性疼痛（APP）的有效药物，尤其是内脏疼痛。然而，控制APP所需的有效剂量取决于手术方式和患者年龄。因此，本研究采用 Dixon 序贯法，调查了羟考酮与肋间神经阻滞（INB）联合应用时，在不同年龄患者行胸腔镜肺手术后有效控制APP的半数有效剂量（ED）。
方法
这是一项前瞻性、干预性、剂量探索性研究。将选择在全身麻醉下行胸腔镜肺叶和肺段切除术的患者，根据年龄和手术方式分为4组：老年肺叶切除组（年龄≥65岁）、非老年肺叶切除组（年龄<65岁）、老年肺段切除组（年龄≥65岁）和非老年肺段切除组（年龄<65岁）。本研究将通过 Dixon 序贯法在四个实验组同时进行。每组第一名患者的初始剂量设定为0.1mg/kg；下一名患者的剂量将根据前一名患者的反应确定。主要结局是羟考酮的ED。
讨论
本研究结果有望为胸腔镜肺手术后APP的管理提供有效策略，特别是为老年患者使用羟考酮提供更准确的剂量指导。这不仅将改善个体化疼痛管理计划的制定，还将优化患者术后恢复，减少不必要的药物副作用，并提高患者的整体舒适度和生活质量。
试验注册
本研究于2024年8月1日在clinicaltrials.gov（NCT06534801）注册。
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