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氢吗啡酮用于骨科手术患者术后自控静脉镇痛的有效性和安全性:一项随机双盲对照试验。

Efficacy and safety of hydromorphone for postoperative patient-controlled intravenous analgesia for patients undergoing orthopedic surgery: a randomized, double-blinded controlled trial.

作者信息

Wang Qi, Zhao Yuanyuan, Ling Bin, Chen Xiangxiang, Xie Yayun, Zhao Haibo, Zhang Jiangang, Wang Wei, Lv Jie

机构信息

Department of Anesthesiology, The Affiliated Jiangning Hospital of Nanjing Medical University, Nangjing, China.

Department of Anesthesiology, Huainan First People's Hospital, The First Affiliated Hospital of Anhui University of Science and Technology, Huainan, China.

出版信息

Front Med (Lausanne). 2025 Apr 28;12:1567328. doi: 10.3389/fmed.2025.1567328. eCollection 2025.

Abstract

BACKGROUND

The study aimed to evaluate the efficacy and safety of hydromorphone in postoperative patient-controlled intravenous analgesia (PCIA) for orthopedic surgery patients, offering a reference for postoperative pain management in this patient population.

METHODS

This was a prospective, randomized, double-blinded, controlled trial involving 80 patients aged 23 to 64 years undergoing elective orthopedic surgery. All participants were randomly assigned to the test group (Group H) and the control group (Group C) by the random number table method. In Group H, hydromorphone (0.2 mg/kg) and palonosetron (4 μg/kg) diluted to 150 mL with saline were used for PCIA, while in Group C, sufentanil (2 μg/kg) and palonosetron (4 μg/kg) were diluted to the same volume. Postoperative pain was assessed using the resting Visual Analog Scale (VAS) at 2, 6, 12, 24, and 48 h postoperatively. The total and effective PCIA button presses within 48 h, along with the number of remedial analgesia cases, were recorded. Ramsay, Awakening time, extubation time, hospital stay duration, and adverse events within 48 h postoperatively were also recorded.

RESULTS

Compared to Group C, Group H had significantly lower VAS scores at 2 and 6 h, as well as Ramsay, SDS, and PSQI scores at 24 and 48 h postoperatively (all  < 0.01). Furthermore, the incidence of dizziness and drowsiness within 48 h postoperatively was significantly reduced in Group H ( = 0.007 and  = 0.003, respectively).

CONCLUSION

Hydromorphone-based PCIA enhances early postoperative pain relief in orthopedic surgery patients, alleviates postoperative depression and sleep disturbances, and reduces the incidence of dizziness and drowsiness.

CLINICAL TRIAL REGISTRATION

This study was registered in the Chinese Clinical Trial. Registry (www.chictr.org.cn) on 01/04/2024 (ChiCTR2400082567).

摘要

背景

本研究旨在评估氢吗啡酮用于骨科手术患者术后自控静脉镇痛(PCIA)的有效性和安全性,为该患者群体的术后疼痛管理提供参考。

方法

这是一项前瞻性、随机、双盲、对照试验,纳入80例年龄在23至64岁之间接受择期骨科手术的患者。所有参与者通过随机数字表法随机分为试验组(H组)和对照组(C组)。H组使用氢吗啡酮(0.2mg/kg)和帕洛诺司琼(4μg/kg)用生理盐水稀释至150mL用于PCIA,而C组使用舒芬太尼(2μg/kg)和帕洛诺司琼(4μg/kg)稀释至相同体积。术后分别于术后2、6、12、24和48小时使用静息视觉模拟量表(VAS)评估疼痛。记录48小时内PCIA的总按压次数和有效按压次数以及补救镇痛病例数。还记录了Ramsay评分、苏醒时间、拔管时间、住院时间以及术后48小时内的不良事件。

结果

与C组相比,H组术后2小时和6小时的VAS评分显著更低,术后24小时和48小时的Ramsay评分、SDS评分和PSQI评分也显著更低(均P<0.01)。此外,H组术后48小时内头晕和嗜睡的发生率显著降低(分别为P=0.007和P=0.003)。

结论

以氢吗啡酮为基础的PCIA可增强骨科手术患者术后早期疼痛缓解,减轻术后抑郁和睡眠障碍,并降低头晕和嗜睡的发生率。

临床试验注册

本研究于2024年4月1日在中国临床试验注册中心(www.chictr.org.cn)注册(ChiCTR2400082567)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d608/12067480/38601bcd366b/fmed-12-1567328-g001.jpg

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