腹腔镜子宫切除术后单次静脉注射对乙酰氨基酚联合奈福泮和芬太尼患者自控镇痛用于术后疼痛控制的相加效应：一项双盲随机对照试验
Additive effect of a single intravenous dose of acetaminophen administered at the end of laparoscopic hysterectomy on postoperative pain control with nefopam and fentanyl-based patient-controlled analgesia: a double-blind, randomized controlled trial.
作者信息
Nam Seungpyo, Yoo Seokha, Park Sun-Kyung, Kim Jin-Tae
机构信息
Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, 101 Daehak-Ro, Jongno-Gu, Seoul, 03080, Korea.
Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Korea.
出版信息
BMC Anesthesiol. 2025 Feb 20;25(1):88. doi: 10.1186/s12871-025-02971-w.
BACKGROUND
Acetaminophen is a widely used analgesic for postoperative pain management. However, data on its combined use with nefopam for managing postoperative pain following laparoscopic hysterectomy are limited. This study evaluated the effects of a single intravenous dose of acetaminophen combined with fentanyl- and nefopam-based patient-controlled analgesia (PCA) in patients undergoing laparoscopic hysterectomy.
METHODS
In this prospective, double-blind, randomized controlled trial, 84 patients were randomized to receive either 1 g of intravenous acetaminophen (treatment group, n = 42) or normal saline (control group, n = 42) at the end of surgery. All patients received fentanyl and nefopam via PCA, postoperatively. PCA consumption, pain scores at rest, and postoperative nausea and vomiting (PONV) scores were assessed at 1, 6, and 24 h postoperatively. Patient satisfaction and opioid-related side effects were also evaluated. The primary outcome was the total PCA consumption within the first 24 h.
RESULTS
No significant difference in 24-h PCA consumption was observed between the control and treatment groups (27.9 ± 16.6 vs. 26.4 ± 11.2, P = 0.623). The pain scores at rest measured at 1, 6, and 24 h after surgery were also not significantly different between the two groups. There were no differences in the satisfaction scores, PONV scores, rescue analgesic use, adverse effects, or length of hospital stay between the groups.
CONCLUSIONS
A single intraoperative dose of intravenous acetaminophen, combined with nefopam- and fentanyl-based PCA, did not significantly reduce analgesic requirements, pain scores at rest, or opioid-related side effects compared with placebo in laparoscopic hysterectomy patients.
TRIAL REGISTRATION
ClinicalTrials.gov (Identifier: NCT03644147 | August 21, 2018).
背景
对乙酰氨基酚是术后疼痛管理中广泛使用的镇痛药。然而，关于其与奈福泮联合用于腹腔镜子宫切除术后疼痛管理的数据有限。本研究评估了腹腔镜子宫切除患者单次静脉注射对乙酰氨基酚联合芬太尼和奈福泮自控镇痛（PCA）的效果。
方法
在这项前瞻性、双盲、随机对照试验中，84例患者在手术结束时随机接受1g静脉注射对乙酰氨基酚（治疗组，n = 42）或生理盐水（对照组，n = 42）。所有患者术后通过PCA接受芬太尼和奈福泮。术后1、6和24小时评估PCA用量、静息时疼痛评分以及术后恶心呕吐（PONV）评分。还评估了患者满意度和阿片类药物相关副作用。主要结局是术后24小时内PCA的总用量。
结果
对照组和治疗组之间24小时PCA用量无显著差异（27.9±16.6 vs. 26.4±11.2，P = 0.623）。两组术后1、6和24小时静息时的疼痛评分也无显著差异。两组在满意度评分、PONV评分、补救性镇痛药使用、不良反应或住院时间方面无差异。
结论
在腹腔镜子宫切除患者中，与安慰剂相比，术中单次静脉注射对乙酰氨基酚联合奈福泮和芬太尼PCA，并未显著降低镇痛需求、静息时疼痛评分或阿片类药物相关副作用。
试验注册
ClinicalTrials.gov（标识符：NCT03644147 | 2018年8月21日）
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