Semenkov A V, Skugarev A L, Tulskih D A, Khitrov N V, Yavorovskaya D A, Sergeev O S
Moscow Regional Research and Clinical Institute («MONIKI»), Moscow, Russia.
I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia.
Khirurgiia (Mosk). 2024(9):38-50. doi: 10.17116/hirurgia202409138.
Evaluation of the analgesic, opioid-sparing, anti-inflammatory and adverse effects of the diclofenac and orphenadrine (Neodolpasse) fixed combination for analgesia in the postoperative period of surgical cancer patients.
A randomized, single-center, prospective, comparative study evaluated two analgesic regimens in 40 cancer patients undergoing various open cavity surgeries, including extensive combined interventions associated with the resection of 3 or more organs. The study was conducted following the transfer from the ICU to the surgical department during the early activation period, within the first two postoperative days. In the first group N (=20), "Neodolpasse" (a fixed combination of 75 mg Diclofenac and 30 mg Orphenadrine) was administered as an infusion, twice daily. In the second group K (=20) analgesia was performed with ketoprofen as an intravenous infusion at a daily dose of 200 mg. Patients in both groups received scheduled prolonged epidural analgesia with 0.2% ropivacaine, and when the severity of pain in a visual analogue scale (VAS) increased to more than 40 mm, so an additional dose of 100 mg tramadol was administered intramuscularly. Daily measurments of blood creatinine level and C-reactive protein were taken, postoperative blood loss was accounted for, as well as postoperative complications according to the Clavien-Dindo classification.
The comparative analysis of the indicators of pain syndrome severity showed that the patients in group N exhibited a more pronounced analgesic effect, so on the second postoperative day 30% of patients reported moderate pain (from 50 to 60 mm on the pain scale), on the third day - 15%, and by the fourth day - all 100% of patients experienced pain of low intensity. The additional analgesia with tramadol in group N was required twice less than in the comparison group, and such adverse effects as nausea, drowsiness, and weakness were significantly more common in the ketoprofen group. In both groups, the average blood creatinine level did not exceed permissible values, and the C-reactive protein was elevated at all stages of the study but tended to decrease by the fourth day. The analysis of postoperative complications according to the Clavien-Dindo scale at the time of discharge did not reveal a direct correlation between the occurred complications and the use of NSAIDs. Adverse effects such as anastomotic failure, gastrointestinal complications, or other hemorrhagic manifestations were not recorded.
The inclusion of Neodolpasse into multimodal analgesic regimens resulted in the most pronounced analgesic and opioid-sparing effects in surgical cancer patients using laparotomy access. Additionally, the application of short courses of nonsteroidal anti-inflammatory drugs (NSAIDs) was associated with a favorable safety profile.
评估双氯芬酸与奥芬那君（Neodolpasse）固定组合在癌症手术患者术后镇痛中的镇痛、阿片类药物节省、抗炎及不良反应。
一项随机、单中心、前瞻性比较研究评估了40例接受各种开放性腔隙手术的癌症患者的两种镇痛方案，包括与3个或更多器官切除相关的广泛联合干预。该研究在术后前两天的早期激活期，从重症监护病房转至外科病房后进行。第一组N（=20），“Neodolpasse”（75mg双氯芬酸与30mg奥芬那君的固定组合）以静脉输注方式给药，每日两次。第二组K（=20），以酮洛芬静脉输注，每日剂量200mg进行镇痛。两组患者均接受0.2%罗哌卡因的计划性延长硬膜外镇痛，当视觉模拟量表（VAS）疼痛严重程度增加至超过40mm时，肌肉注射额外剂量100mg曲马多。每日测量血肌酐水平和C反应蛋白，记录术后失血量以及根据Clavien-Dindo分类的术后并发症。
疼痛综合征严重程度指标的比较分析表明，N组患者的镇痛效果更为显著，因此在术后第二天，30%的患者报告中度疼痛（疼痛量表上为50至60mm），第三天为15%，到第四天，所有100%的患者经历低强度疼痛。N组曲马多的额外镇痛需求比对照组少一半，酮洛芬组恶心、嗜睡和虚弱等不良反应明显更常见。两组中，平均血肌酐水平均未超过允许值，C反应蛋白在研究的所有阶段均升高，但到第四天有下降趋势。出院时根据Clavien-Dindo量表对术后并发症的分析未发现发生的并发症与非甾体抗炎药的使用之间存在直接关联。未记录到吻合口失败、胃肠道并发症或其他出血表现等不良反应。
在采用剖腹手术入路的癌症手术患者中，将Neodolpasse纳入多模式镇痛方案可产生最显著的镇痛和阿片类药物节省效果。此外，短期使用非甾体抗炎药（NSAIDs）具有良好的安全性。
