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腹腔镜辅助与超声引导腹横肌平面阻滞在腹腔镜结直肠手术后镇痛效果的比较:一项随机、单盲、非劣效性试验。

Comparison of Analgesic Efficacy of Laparoscope-Assisted and Ultrasound-Guided Transversus Abdominis Plane Block after Laparoscopic Colorectal Operation: A Randomized, Single-Blind, Non-Inferiority Trial.

机构信息

Colorectal Cancer Center, Kyungpook National University Medical Center, School of Medicine, Kyungpook National University, Daegu, Korea.

Department of Anesthesiology and Pain Medicine, Kyungpook National University Medical Center, School of Medicine, Kyungpook National University, Daegu, Korea.

出版信息

J Am Coll Surg. 2017 Sep;225(3):403-410. doi: 10.1016/j.jamcollsurg.2017.05.017. Epub 2017 Jun 10.

DOI:10.1016/j.jamcollsurg.2017.05.017
PMID:28610880
Abstract

BACKGROUND

Transversus abdominis plane (TAP) block has been used as a component of multimodal analgesia after abdominal operation. We introduced a new laparoscope-assisted TAP (LTAP) block technique using intraperitoneal injection and compared its analgesic effect with that of an ultrasound-guided TAP (UTAP) block in terms of postoperative pain control.

STUDY DESIGN

A prospective, randomized, single-blinded non-inferiority clinical trial was conducted with patients undergoing elective laparoscopic colectomy for colon cancer. Eighty patients were randomly assigned (1:1 ratio) to the UTAP and LTAP groups. At the end of the operation, opioid consumption and numeric rating scores (NRS; 0 [no pain] to 10 [worst pain]) of pain were recorded at 2, 6, 24, and 48 hours postoperatively and were compared between the groups. The primary end point was pain NRS during rest at 24 hours after operation.

RESULTS

Thirty-eight patients in the LTAP group and 35 patients in the UTAP group completed the study protocol. We found no significant difference in mean ± SD pain NRS during rest at 24 hours between the LTAP group (3.90 ± 1.7) and the UTAP group (4.5 ± 1.9). The mean difference in pain NRS during rest at 24 hours was 0.57 (95% CI -0.26 to 1.41). Because the lower boundary of a 95% CI for the differences in pain NRS was > -1, non-inferiority was established. There was no significant difference between the groups in NRS pain during rest, NRS pain on movement, and postoperative morphine consumption during the 48 hours after operation.

CONCLUSIONS

These results show our new LTAP block technique was non-inferior to the ultrasound-guided technique in providing a TAP block after laparoscopic colorectal operation.

摘要

背景

腹横肌平面(TAP)阻滞已被用作腹部手术后多模式镇痛的一部分。我们引入了一种新的腹腔镜辅助 TAP(LTAP)阻滞技术,采用腹腔内注射,并比较了其与超声引导 TAP(UTAP)阻滞在术后疼痛控制方面的镇痛效果。

研究设计

这是一项前瞻性、随机、单盲非劣效性临床试验,纳入了接受择期腹腔镜结直肠癌切除术的患者。80 名患者被随机分配(1:1 比例)至 UTAP 和 LTAP 组。在手术结束时,记录术后 2、6、24 和 48 小时的阿片类药物消耗和数字评分(NRS;0 [无痛]至 10 [最痛]),并比较两组之间的差异。主要终点是术后 24 小时静息时的疼痛 NRS。

结果

LTAP 组 38 例和 UTAP 组 35 例患者完成了研究方案。我们发现 LTAP 组(3.90 ± 1.7)和 UTAP 组(4.5 ± 1.9)在 24 小时静息时的平均 ± 标准差疼痛 NRS 之间没有显著差异。24 小时静息时疼痛 NRS 的平均差异为 0.57(95%CI -0.26 至 1.41)。由于差异的 95%CI 下限大于-1,因此确立了非劣效性。两组在术后 48 小时内的静息时 NRS 疼痛、运动时 NRS 疼痛和术后吗啡消耗方面均无显著差异。

结论

这些结果表明,我们的新 LTAP 阻滞技术在提供腹腔镜结直肠手术后 TAP 阻滞方面不劣于超声引导技术。

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