超声引导下多注射法横突间阻滞与胸椎旁阻滞用于乳腺癌大手术的比较：一项随机非劣效性试验

Comparison between ultrasound-guided multi-injection intertransverse process and thoracic paravertebral blocks for major breast cancer surgery: a randomized non-inferiority trial.

作者信息

Zhang Hongye, Qu Zongyang, Miao Yongsheng, Zhang Yuelun, Qian Lulu, Hua Bin, Hua Zhen

机构信息

Department of Anesthesiology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, China.

Medical Research Center, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.

出版信息

Reg Anesth Pain Med. 2023 Apr;48(4):161-166. doi: 10.1136/rapm-2022-104003. Epub 2022 Dec 15.

DOI:10.1136/rapm-2022-104003

PMID:36522043

Abstract

BACKGROUND

This study investigated whether a novel multi-injection intertransverse process block could provide non-inferior analgesia and recovery quality following major breast cancer surgery compared with the multi-injection thoracic paravertebral block.

METHODS

Eighty-eight females who underwent mastectomy plus sentinel or axillary lymph node dissection were randomized to receive either intertransverse process block or thoracic paravertebral block, both performed at T2-6 with 5 mL of 0.5% ropivacaine per level. The primary outcome was the worst resting pain score (11-point Numerical Rating Scale) within 30 min in the recovery room. The secondary outcome was recovery quality (15-item quality of recovery scale) 24 hours after surgery, which was tested following a gatekeeping procedure.

RESULTS

The worst resting pain scores were 0 (0, 1) in the intertransverse process block group vs 0.5 (0, 2) in the thoracic paravertebral block group, with a median difference of 0 (95% CI 0 to 0); the upper 95% CI limit was lower than the prespecified non-inferiority margin of 1 point (non-inferiority p<0.001). Aggregate scores of recovery quality at 24 hours postoperatively were 137.5 (126.5, 142.8) and 137.5 (127.8, 145.0) for the intertransverse process and thoracic paravertebral block groups, respectively, with a median difference of -1 (95% CI -6 to 3); the lower 95% CI limit was larger than the prespecified non-inferiority margin of -8 (non-inferiority p=0.006).

CONCLUSIONS

Compared with a multi-injection thoracic paravertebral block, the multi-injection intertransverse process block provided non-inferior analgesia within 30 min in the recovery room and recovery quality at 24 hours following major breast cancer surgery in females.

TRIAL REGISTRATION NUMBER

ChiCTR2000037963.

摘要

背景

本研究旨在调查一种新型多注射横突间阻滞与多注射胸段椎旁阻滞相比，在女性乳腺癌大手术后能否提供非劣效性镇痛及恢复质量。

方法

88例行乳房切除术加前哨或腋窝淋巴结清扫术的女性被随机分为接受横突间阻滞或胸段椎旁阻滞，均在T2-6节段进行，每节段注射5毫升0.5%罗哌卡因。主要结局为恢复室内30分钟内的最严重静息疼痛评分（11分数字评定量表）。次要结局为术后24小时的恢复质量（15项恢复质量量表），在采用把关程序后进行测试。

结果

横突间阻滞组最严重静息疼痛评分为0（0，1），胸段椎旁阻滞组为0.5（0，2），中位数差异为0（95%CI 0至0）；95%CI上限低于预先设定的非劣效性界值1分（非劣效性p<0.001）。术后24小时横突间阻滞组和胸段椎旁阻滞组的恢复质量总分分别为137.5（126.5，142.8）和137.5（127.8，145.0），中位数差异为-1（95%CI -6至3）；95%CI下限大于预先设定的非劣效性界值-8（非劣效性p=0.006）。