Department of Thoracic Surgery, West China Hospital, Sichuan University, Chengdu, No. 37, Guoxue Alley, Chengdu, 610041, Sichuan, China.
West China School of Medicine, Sichuan University, Chengdu, China.
Trials. 2021 Mar 1;22(1):175. doi: 10.1186/s13063-021-05108-9.
The optimal analgesic strategy for surgical pain after lobectomy remains undefined. To compare the combination of flurbiprofen axetil and dezocine with flurbiprofen axetil alone and dezocine alone, in post-lobectomy patients.
A single-center, parallel-design double-blind superiority trial, with 5 groups (1:1:1:1:1 ratio) with different combinations of flurbiprofen and dezocine. Patients scheduled for lobectomy will be recruited. The primary outcome is total sufentanil use in patient-controlled intravenous analgesia within the first 24 postoperative hours. Secondary outcomes include pain numeric rating scales at 6th, 12th, 24th, 48th, and 72th postoperative hours, and on the 1st, 3rd, and 6th postoperative months at rest and during coughing, adverse effects from experimental drug treatment, sufentanil use at other time points, analgesia cost, time to chest tube removal, length of hospital stay, time to pass first flatus, and serum level of cytokines. Doctors, patients, and nurses are blinded, and only the manager is unblinded. Analysis is intention-to-treat. Statistical analysis is pre-specified. Statistical comparison of the treatment groups includes one-way analysis of variance followed by Tukey's post hoc test.
Trial did not begin to recruit. Participant recruitment start date is planned to be June 1, 2020. Approximate recruitment end date is May 31, 2021. If successful, the trial may shed light on the use of certain analgesic combinations in post-lobectomy pain control.
Chinese Clinical Trial Registry ChiCTR1800018563 . Registered on September 25, 2018.
肺叶切除术后手术疼痛的最佳镇痛策略仍未确定。本研究旨在比较氟比洛芬酯联合地佐辛与氟比洛芬酯单药和地佐辛单药用于肺叶切除术后患者的效果。
这是一项单中心、平行设计、双盲优效性试验，采用氟比洛芬酯联合地佐辛（5 组，1:1:1:1:1 比例）、氟比洛芬酯单药和地佐辛单药的不同组合。纳入择期行肺叶切除术的患者。主要结局是术后 24 小时内患者自控静脉镇痛中舒芬太尼的总用量。次要结局包括术后第 6、12、24、48 和 72 小时以及术后第 1、3 和 6 个月静息和咳嗽时的疼痛数字评分量表，以及舒芬太尼在其他时间点的使用、实验性药物治疗的不良反应、镇痛费用、胸腔引流管拔除时间、住院时间、首次排气时间和细胞因子血清水平。医生、患者和护士均设盲，仅管理员设为非盲。分析采用意向治疗。统计分析为预先设定。治疗组间的统计比较包括单因素方差分析，随后进行 Tukey 事后检验。
试验尚未开始招募。预计于 2020 年 6 月 1 日开始招募参与者，计划于 2021 年 5 月 31 日结束招募。如果成功，该试验可能为肺叶切除术后疼痛控制中某些镇痛联合方案的应用提供参考。
中国临床试验注册中心，ChiCTR1800018563 号，于 2018 年 9 月 25 日注册。
