Ultrasound-guided erector spinae plane block versus paravertebral block for postoperative analgesia in mastectomy and immediate breast reconstruction: a randomized non-inferiority trail

Caroline W. van der Zee, Emilie M.A.L.C. Fentener van Vlissingen, Hoa Thi Tran, Anoek de Winter, Vana Karim, Annelotte C.M. van Bommel, Marie Jeanne T.F.D. Vrancken Peeters, Suzanne Broens
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Abstract

Purpose

Immediate breast reconstruction (IBR) after mastectomy improves aesthetic and psychological outcomes in breast cancer patients, but is associated with significant pain. The paravertebral block (PVB) is the current gold standard, but the erector spinae plane block (ESPB) may offer comparable analgesia with technical simplicity and improved safety.

Methods

A total of hundred patients undergoing mastectomy with subpectoral IBR were randomized to receive either ESPB or PVB. Primary endpoints were highest Numerical Rating Scale (NRS) pain scores and opioid consumption in the post-anesthesia care unit (PACU). Secondary outcomes were block success rate; ease of procedure; length of PACU stay; highest reported NRS and total opioid dose administered in the ward; incidence of complications of the block and patient satisfaction.

Results

ESPB did not meet non-inferiority criteria compared with PVB in the PACU for highest NRS (difference 1.0; 95% CI 0.1–1.9; p = 0.032) or opioid use (difference 2 mg morphine equivalent (MEQ)); 95% bootstrap 0–4; p = 0.056). ESPB showed better visualization of local anesthetic spread and was significantly easier to perform. PACU duration, highest NRS score and total opioid dose, complications of the nerve block and patient satisfaction were comparable for the two groups.

Conclusions

Failure to demonstrate non-inferiority was possibly caused by under powering, suboptimal dosing and operator experience. Considering the significant simplicity and lower procedural risk of ESPB, ESPB may be practical alternative compared to PVB, especially in low PVB volume centers and should be considered for use in patients undergoing mastectomy combined with IBR.

Clinical trial registration number

NL75733.031.20.
超声引导下直立者脊柱平面阻滞与椎旁阻滞对乳房切除术和立即乳房重建术后镇痛的影响:一项随机非效性试验
目的乳房切除术后立即乳房重建(IBR)改善了乳腺癌患者的美学和心理结果,但与明显的疼痛相关。椎旁阻滞(PVB)是目前的金标准,但竖脊机脊柱平面阻滞(ESPB)可以提供技术简单且安全性更高的类似镇痛。方法100例乳房切除术合并胸下IBR患者随机接受ESPB或PVB治疗。主要终点是最高的数值评定量表(NRS)疼痛评分和麻醉后护理单位(PACU)的阿片类药物消耗。次要指标为阻滞成功率;简化程序;PACU停留时间;报告的最高NRS和病房内给予的阿片类药物总剂量;并发症发生率与患者满意度。结果espb在最高NRS(差异1.0;95% CI 0.1-1.9; p = 0.032)或阿片类药物使用(差异2 mg吗啡当量(MEQ))方面与PVB相比不符合非劣效性标准;95% bootstrap 0-4; = 0.056页)。ESPB能更好地显示局麻扩散,且明显更容易操作。PACU持续时间、最高NRS评分和阿片类药物总剂量、神经阻滞并发症和患者满意度两组比较具有可比性。结论未能证明非劣效性可能是由于功率不足、给药不理想和操作人员的经验所致。考虑到ESPB的简单性和较低的手术风险,与PVB相比,ESPB可能是一种实用的替代方案,特别是在低PVB体积中心,应考虑在乳房切除术合并IBR的患者中使用。临床试验注册号bernl75733.031.20。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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