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鞘内吗啡和硬膜外镇痛对妇科恶性肿瘤腹部手术后恢复的影响:一项开放标签随机试验。

Effect of intrathecal morphine and epidural analgesia on postoperative recovery after abdominal surgery for gynecologic malignancy: an open-label randomised trial.

机构信息

Children and Women's Health, Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.

Department of Obstetrics and Gynecology, Vrinnevisjukhuset i Norrkoping, Norrkoping, Sweden.

出版信息

BMJ Open. 2019 Mar 4;9(3):e024484. doi: 10.1136/bmjopen-2018-024484.

Abstract

OBJECTIVES

We aimed to determine whether regional analgesia with intrathecal morphine (ITM) in an enhanced recovery programme (enhanced recovery after surgery [ERAS]) gives a shorter hospital stay with good pain relief and equal health-related quality of life (QoL) to epidural analgesia (EDA) in women after midline laparotomy for proven or assumed gynaecological malignancies.

DESIGN

An open-label, randomised, single-centre study.

SETTING

A tertiary referral Swedish university hospital.

PARTICIPANTS

Eighty women, 18-70 years of age, American Society of Anesthesiologists I and II, admitted consecutively to the department of Obstetrics and Gynaecology.

INTERVENTIONS

The women were allocated (1:1) to either the standard analgesic method at the clinic (EDA) or the experimental treatment (ITM). An ERAS protocol with standardised perioperative routines and standardised general anaesthesia were applied. The EDA or ITM started immediately preoperatively. The ITM group received morphine, clonidine and bupivacaine intrathecally; the EDA group had an epidural infusion of bupivacaine, adrenalin and fentanyl.

PRIMARY AND SECONDARY OUTCOME MEASURES

Primary endpoint was length of hospital stay (LOS). Secondary endpoints were QoL and pain assessments.

RESULTS

LOS was statistically significantly shorter for the ITM group compared with the EDA group (median [IQR]3.3 [1.5-56.3] vs 4.3 [2.2-43.2] days; p=0.01). No differences were observed in pain assessment or QoL. The ITM group used postoperatively the first week significantly less opioids than the EDA group (median (IQR) 20 mg (14-35 mg) vs 81 mg (67-101 mg); p<0.0001). No serious adverse events were attributed to ITM or EDA.

CONCLUSIONS

Compared with EDA, ITM is simpler to administer and manage, is associated with shorter hospital stay and reduces opioid consumption postoperatively with an equally good QoL. ITM is effective as postoperative analgesia in gynaecological cancer surgery.

TRIAL REGISTRATION NUMBER

NCT02026687; Results.

摘要

目的

我们旨在确定在强化康复方案(术后强化康复)中使用鞘内吗啡(ITM)进行区域镇痛是否可以缩短中位剖腹手术后患有或疑似妇科恶性肿瘤的女性的住院时间,同时提供良好的疼痛缓解并具有相等的健康相关生活质量(QoL)。

设计

开放标签、随机、单中心研究。

地点

瑞典一家三级转诊大学医院。

参与者

连续纳入妇产科的 80 名年龄在 18-70 岁之间的美国麻醉医师协会 I 级和 II 级女性。

干预措施

女性被随机分配(1:1)至诊所的标准镇痛方法(EDA)或实验组(ITM)。应用强化康复方案,包括标准化围手术期常规和标准化全身麻醉。EDA 或 ITM 在术前立即开始。ITM 组接受鞘内注射吗啡、可乐定和布比卡因;EDA 组接受布比卡因、肾上腺素和芬太尼硬膜外输注。

主要和次要结局测量

主要终点是住院时间(LOS)。次要终点是 QoL 和疼痛评估。

结果

与 EDA 组相比,ITM 组的 LOS 明显缩短(中位数 [IQR]3.3 [1.5-56.3] 与 4.3 [2.2-43.2] 天;p=0.01)。疼痛评估或 QoL 无差异。ITM 组在术后第一周使用的阿片类药物明显少于 EDA 组(中位数(IQR)20mg(14-35mg)与 81mg(67-101mg);p<0.0001)。未将 ITM 或 EDA 相关的严重不良事件归因于 ITM 或 EDA。

结论

与 EDA 相比,ITM 给药和管理更简单,住院时间更短,术后阿片类药物消耗减少,同时 QoL 相同。ITM 是妇科癌症手术后有效的术后镇痛方法。

试验注册

NCT02026687;结果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d74f/6430030/8446f2d170f5/bmjopen-2018-024484f01.jpg

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