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癸酸地布啡诺对电视辅助胸腔镜手术术后多模式镇痛策略的影响:一项双盲随机对照试验

Effect of Dinalbuphine sebacate on postoperative multimodal analgesic strategy in video-assisted thoracoscopic surgery: a double-blind randomized controlled trial.

作者信息

Hsu Hung-Te, Ma Chao-Wei, Chang Po-Chih, Kuo Yi-Wei, Gau Tz-Ping, Liu Yu-Wei, Liu Yen-Chin, Chou Shah-Hwa, Cheng Kuang-I

机构信息

Department of Anesthesiology, Kaohsiung Medical University Hospital, Kaohsiung, 80756, Taiwan.

Department of Anesthesiology, School of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan.

出版信息

BMC Anesthesiol. 2025 May 17;25(1):252. doi: 10.1186/s12871-025-03118-7.

DOI:10.1186/s12871-025-03118-7
PMID:40382572
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12084954/
Abstract

BACKGROUND

Multimodal analgesia (MMA) combines different analgesic methods, such as non-steroidal inflammatory drugs (NSAIDs), acetaminophen, and regional anesthesia techniques, to optimize pain control while minimizing opioid use. Dinalbuphine sebacate (DS), a long-acting prodrug of nalbuphine, was chosen due to its potential to enhance MMA strategies. The aim of this study is to evaluate the effectiveness of DS in MMA for video-assisted thoracoscopic surgery (VATS).

METHODS

Sixty participants were randomly and equally assigned to either the MMA regimen containing DS (DS group) or placebo (placebo group). After anesthesia induction, all participants received ultrasound-guided thoracic paravertebral block (TPVB), and DS or placebo was injected into the gluteus medius muscle on the operated side. Intravenous patient-controlled analgesia (IVPCA) with fentanyl was provided for breakthrough pain postoperatively. The primary outcome was postoperative fentanyl consumption over three days. Statistical tests included Student's t-test, chi-square test, and Fisher's exact test.

RESULTS

Finally, 57 participants were assigned to either the DS group (n = 28) or the placebo group (n = 29). The mean fentanyl consumption over three days was significantly lower in the DS group (283 ± 70 µg) compared to the placebo group (708 ± 190 µg, P < 0.001). Pain interference with daily life was significantly lower in the DS group at one week (28.57% vs. 86.2%, P < 0.001) and one month postoperatively (10.71% vs. 48.28%, P = 0.003). Pain intensity during movement was significantly lower in the DS group at one week (2.07 ± 0.61 vs. 4.00 ± 0.56, P < 0.001) and one month (0.64 ± 0.35 vs. 2.10 ± 0.4, P < 0.001).

CONCLUSIONS

By providing superior analgesia, reducing opioid requirements, improving functional recovery and its long-lasting effect after discharge, DS enhanced postoperative MMA for VATS.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier, NCT04962152; Date: 14/07/2021.

摘要

背景

多模式镇痛(MMA)结合了不同的镇痛方法,如非甾体类抗炎药(NSAIDs)、对乙酰氨基酚和区域麻醉技术,以优化疼痛控制同时尽量减少阿片类药物的使用。由于其有增强MMA策略的潜力,因此选择了丁丙诺啡癸酸酯(DS),一种丁丙诺啡的长效前体药物。本研究的目的是评估DS在MMA用于电视辅助胸腔镜手术(VATS)中的有效性。

方法

60名参与者被随机且平均分配至含DS的MMA方案组(DS组)或安慰剂组。麻醉诱导后,所有参与者均接受超声引导下胸椎旁神经阻滞(TPVB),并将DS或安慰剂注入手术侧的臀中肌。术后为突破性疼痛提供芬太尼静脉自控镇痛(IVPCA)。主要结局是术后三天内芬太尼的消耗量。统计检验包括Student's t检验、卡方检验和Fisher精确检验。

结果

最终,57名参与者被分配至DS组(n = 28)或安慰剂组(n = 29)。与安慰剂组(708±190μg)相比,DS组三天内的平均芬太尼消耗量显著更低(283±70μg,P < 0.001)。DS组在术后一周(28.57%对86.2%,P < 0.001)和术后一个月(10.71%对48.28%,P = 0.003),疼痛对日常生活的干扰显著更低。DS组在术后一周(2.07±0.61对4.00±0.56,P < 0.001)和术后一个月(0.64±0.35对2.10±0.4,P < 0.001),运动时的疼痛强度显著更低。

结论

通过提供卓越的镇痛效果、减少阿片类药物需求、改善功能恢复及其出院后的长效作用,DS增强了VATS术后的MMA效果。

试验注册

ClinicalTrials.gov标识符,NCT04962152;日期:2021年7月14日。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0490/12084954/74f325ce2aee/12871_2025_3118_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0490/12084954/bc5de7b86031/12871_2025_3118_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0490/12084954/88456480d2ed/12871_2025_3118_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0490/12084954/74f325ce2aee/12871_2025_3118_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0490/12084954/bc5de7b86031/12871_2025_3118_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0490/12084954/88456480d2ed/12871_2025_3118_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0490/12084954/74f325ce2aee/12871_2025_3118_Fig3_HTML.jpg

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