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外科医生实施的腹腔镜腹横肌平面阻滞不劣于麻醉医生实施的超声引导腹横肌平面阻滞:一项盲法、随机非劣效性试验。

Surgeon-delivered laparoscopic transversus abdominis plane blocks are non-inferior to anesthesia-delivered ultrasound-guided transversus abdominis plane blocks: a blinded, randomized non-inferiority trial.

机构信息

Division of Colon & Rectum Surgery, Beth Israel Lahey Health Medical Center, Harvard Medical School, Boston, MA, 02215, USA.

Beth Israel Lahey Health Medical Center, 330 Brookline Avenue, Gryzmish Building 6th Floor, Boston, MA, 02215, USA.

出版信息

Surg Endosc. 2020 Jul;34(7):3011-3019. doi: 10.1007/s00464-019-07097-y. Epub 2019 Sep 4.

DOI:10.1007/s00464-019-07097-y
PMID:31485929
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7103091/
Abstract

BACKGROUND

The transversus abdominis plane (TAP) block is an important non-narcotic adjunct for post-operative pain control in abdominal surgery. Surgeons can use laparoscopic guidance for TAP block placement (LTAP), however, direct comparisons to conventional ultrasound-guided TAP (UTAPs) have been lacking. The aim of this study is to determine if surgeon placed LTAPs were non-inferior to anesthesia placed UTAPs for post-operative pain control in laparoscopic colorectal surgery.

METHODS

This was a prospective, randomized, patient and observer blinded parallel-arm non-inferiority trial conducted at a single tertiary academic center between 2016 and 2018 on adult patients undergoing laparoscopic colorectal surgery. Narcotic consumption and pain scores were compared for LTAP vs. UTAP for 48 h post-operatively.

RESULTS

60 patients completed the trial (31 UTAP, 29 LTAP) of which 25 patients were female (15 UTAP, 10 LTAP) and the mean ages (SD) were 60.0 (13.6) and 61.5 (14.3) in the UTAP and LTAP groups, respectively. There was no significant difference in post-operative narcotic consumption between UTAP and LTAP at the time of PACU discharge (median [IQR] milligrams of morphine, 1.8 [0-4.5] UTAP vs. 0 [0-8.7] LTAP P = .32), 6 h post-operatively (5.4 [1.8-17.1] UTAP vs. 3.6 [0-12.6] LTAP P = .28), at 12 h post-operatively (9.0 [3.6-29.4] UTAP vs. 7.2 [0.9-22.5] LTAP P = .51), at 24 h post-operatively (9.0 [3.6-29.4] UTAP vs. 7.2 [0.9-22.5] LTAP P = .63), and 48 h post-operatively (39.9 [7.5-70.2] UTAP vs. 22.2 [7.5-63.8] LTAP P = .41). Patient-reported pain scores as well as pre-, intra-, and post-operative course were similar between groups. Non-inferiority criteria were met at all post-op time points up to and including 24 h but not at 48 h.

CONCLUSIONS

Surgeon-delivered LTAPs are safe, effective, and non-inferior to anesthesia-administered UTAPs in the immediate post-operative period.

TRIAL REGISTRY

The trial was registered at clinicaltrials.gov Identifier NCT03577912.

摘要

背景

腹横肌平面(TAP)阻滞是腹部手术后控制术后疼痛的重要非阿片类辅助手段。外科医生可以使用腹腔镜引导进行 TAP 阻滞(LTAP),但缺乏与传统超声引导 TAP(UTAP)的直接比较。本研究旨在确定外科医生放置的 LTAP 在腹腔镜结直肠手术后的术后疼痛控制方面是否不劣于麻醉师放置的 UTAP。

方法

这是一项前瞻性、随机、患者和观察者盲法平行臂非劣效性试验,于 2016 年至 2018 年在一家单中心三级学术中心进行,纳入接受腹腔镜结直肠手术的成年患者。术后 48 小时比较 LTAP 与 UTAP 的阿片类药物消耗和疼痛评分。

结果

60 例患者完成了试验(31 例 UTAP,29 例 LTAP),其中 25 例为女性(15 例 UTAP,10 例 LTAP),UTAP 和 LTAP 组的平均年龄(标准差)分别为 60.0(13.6)和 61.5(14.3)。在 PACU 出院时(中位数[IQR]吗啡毫克数,UTAP 为 1.8[0-4.5],LTAP 为 0[0-8.7],P=0.32)、术后 6 小时(5.4[1.8-17.1]UTAP 与 3.6[0-12.6]LTAP,P=0.28)、术后 12 小时(9.0[3.6-29.4]UTAP 与 7.2[0.9-22.5]LTAP,P=0.51)、术后 24 小时(9.0[3.6-29.4]UTAP 与 7.2[0.9-22.5]LTAP,P=0.63)和术后 48 小时(39.9[7.5-70.2]UTAP 与 22.2[7.5-63.8]LTAP,P=0.41),UTAP 和 LTAP 之间的阿片类药物消耗无显著差异。患者报告的疼痛评分以及术前、术中、术后过程在组间相似。所有术后时间点直至包括 24 小时均符合非劣效性标准,但 48 小时时不符合。

结论

外科医生实施的 LTAP 在术后即刻与麻醉师实施的 UTAP 一样安全、有效且不劣于后者。

试验注册

该试验在 clinicaltrials.gov 注册,标识符为 NCT03577912。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9a64/7103091/22381e0a54b3/nihms-1573523-f0004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9a64/7103091/efd23872fc65/nihms-1573523-f0001.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9a64/7103091/ef7cecf12901/nihms-1573523-f0003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9a64/7103091/22381e0a54b3/nihms-1573523-f0004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9a64/7103091/efd23872fc65/nihms-1573523-f0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9a64/7103091/823b226dcba0/nihms-1573523-f0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9a64/7103091/ef7cecf12901/nihms-1573523-f0003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9a64/7103091/22381e0a54b3/nihms-1573523-f0004.jpg

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