国际麻醉学与复苏杂志   2025, Issue (3): 0-0
    
对乙酰氨基酚用于食管内镜黏膜下剥离术术后镇痛的有效性和安全性：一项前瞻性、随机、双盲、安慰剂对照试验
邢文鑫, 张宗旺, 赵同航, 武姗姗, 申文龙, 路可欣1()
1.山东第一医科大学（山东省医学科学院）研究生部
Efficacy and safety of paracetamol for postoperative analgesia after endoscopic mucosal dissection of the esophagus：A prospective, randomized, double-blind, placebo-controlled trial
 全文:
摘要：

目的 探讨手术结束前静脉注射对乙酰氨基酚用于食管内镜黏膜下剥离术（endoscopic mucosal dissection，ESD）术后镇痛的有效性和安全性。方法 选取2023年2月至2023年5月于聊城市人民医院择期在气管插管静吸复合全身麻醉下行食管ESD患者78例，随机分为对乙酰氨基酚组（P组，n=38）和对照组（C组，n=40），对乙酰氨基酚组于手术结束前20 min静脉注射500 mg对乙酰氨基酚，对照组给予等量0.9%氯化钠溶液。记录患者离开麻醉后监测治疗室（postanesthesia care unit，PACU）即刻、术后2、6、24 h活动和静息视觉模拟评分（visual analogue scale, VAS）评分，补救性镇痛药物使用情况，术后24 h血液白细胞计数及变化，术后24 h发热情况，术后恶心、呕吐、头晕发生率以及术后出血、穿孔发生率。 结果 与C组相比，P组离开PACU即刻（差值：-0.53，95%CI：-0.87~-0.19，P=0.003）、术后2 h（差值：-0.61，95%CI：-1.07~-0.15，P=0.010）、术后6 h（差值：-1.27，95%CI：-1.86~-0.68，P＜0.001）活动VAS评分和离开PACU即刻（差值：-0.62，95%CI：-0.96~-0.28，P＜0.001）、术后2 h（差值：-0.75，95%CI：-1.16~-0.33，P＜0.001）、术后6 h（差值：-1.01，95%CI：-1.52~-0.50，P＜0.001）静息VAS评分均降低，但术后24 h活动VAS评分和静息VAS评分未见明显差异，组内分析示术后6 h VAS评分较高。同时，对乙酰氨基酚组患者补救性镇痛药物使用频率较低，但两者差异无统计学意义[ 5（13.16）vs 11（27.50），P=0.072 ]。两组患者术后24 h血液白细胞计数及变化、术后24 h发热情况以及恶心、呕吐、头晕发生率方面均无显著差异，且均未发生术后出血和穿孔。结论 手术结束前静脉注射对乙酰氨基酚可有效缓解食管ESD术后疼痛，并且不会增加术后恶心、呕吐、头晕以及出血和穿孔等不良反应的发生率。
关键词： 对乙酰氨基酚；内镜黏膜下剥离术；疼痛
Abstract:

Objective To investigate the efficacy and safety of intravenous paracetamol for postoperative analgesia after esophageal ESD before the end of the operation. Methods Seventy-eight patients who underwent esophageal ESD under tracheal intubation with combined intravenous and inhalation general anesthesia were included in this study, conducted on an elective basis at Liaocheng People's Hospital between February and May 2023. The patients were randomly divided into two groups: the paracetamol group (group P, n=38) and the control group (group C, n=40). The paracetamol group was administered an intravenous injection of 500 mg of paracetamol 20 minutes before the end of the operation, while the control group received saline.The VAS pain scores at activity and rest were recorded immediately after leaving PACU，2，6 and 24 hours after surgery．Additionally,remedial analgesic drug usage, 24-hour postoperative blood leukocyte counts and variations, postoperative fever after 24 hours, incidence of post-operative nausea, vomiting, and dizziness, as well as the incidence of postoperative haemorrhage and perforation were noted. Results Compared with group C,group P had lower VAS scores for activity immediately after leaving PACU(difference:-0.53,95%CI:-0.87~-0.19,P=0.003), at 2 hours after surgery(difference:-0.61,95%CI:-1.07~-0.15,P=0.010) and 6 hours after surgery(difference:-1.27,95%CI:-1.86~-0.68,P0.001).Additionally, resting VAS scores were lower for Group P immediately after leaving the PACU(difference:-0.62,95%CI:-0.96~-0.28,P0.001) and at 2 hours after surgery(difference:-0.75,95%CI:-1.16~-0.33,P0.001) and 6 hours after surgery(difference:-1.01,95%CI:-1.52~-0.50,P0.001) . However, no significant difference was found between the VAS scores during the VAS pain scores at activity and rest at 24 hours after surgery, and the within-group analysis showed higher VAS scores at 2 hours and 6 hours after surgery. The frequency of remedial analgesic drug usage tended to decrease in patients in the acetaminophen group, but the difference was not statistically significant[ 5（13.16）vs 11（27.50），P=0.072 ].There were no significant differences between the two groups in terms of 24-hour postoperative blood leukocyte counts and variations, postoperative fever after 24 hours, incidence of post-operative nausea, vomiting, and dizziness, and none of them suffered from postoperative haemorrhage or perforation. Conclusion Intravenous paracetamol administered before the end of the operation is effective in relieving postoperative pain in esophageal ESD.Additionally, it does not increase the incidence of adverse reactions such as postoperative nausea, vomiting, dizziness, haemorrhage and perforation.
Key words: Paracetamol;Endoscopic mucosal dissection;Pain