The addition of interpectoral and pectoserratus fascial plane blocks to paravertebral blocks for analgesia after total mastectomy and immediate breast reconstruction: a pilot feasibility randomized controlled trial.

IF 3.3 3区 医学 Q1 ANESTHESIOLOGY
Hannah Wells, Krisha Malik, Penelope M A Brasher, Esta Bovill, Nancy Van Laeken, Rebecca Warburton, Christopher Prabhakar, Xi Lisa Li, Kathryn V Isaac
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引用次数: 0

Abstract

Purpose: Postmastectomy breast reconstruction (BR) may be associated with significant postoperative pain. Use of regional anesthetic blocks has been identified as a potentially beneficial technique to reduce perioperative pain. We sought to conduct a pilot feasibility trial to evaluate the addition of interpectoral and pectoserratus blocks to thoracic paravertebral blocks (TPVBs).

Methods: We conducted a pilot feasibility randomized controlled trial (RCT) at the Providence Breast Centre (Mount Saint Joseph's Hospital, Vancouver, BC, Canada), between 7 May 2021 and 17 March 2023. Adult female patients undergoing BR using tissue expanders or implants were randomized (1:1) to receive TPVB + interpectoral and pectoserratus blocks (intervention) or TPVB + saline (control). Feasibility outcomes related to recruitment, retention, block administration, and safety. We also measured numerical rating scale (NRS) pain scores 24 hr postoperatively and assessed whether the lower bound of the 80% confidence interval (CI) for the between-group difference in mean scores was > 0.

Results: Of 83 eligible patients, 30 (36%) were randomized. Average recruitment was 1.3 patients per month; all blocks were successfully administered, and there were no complications associated with the blocks. Retention to the end of follow-up (six months) was 90%. Mean (standard deviation) self-reported NRS pain scores at 24 hr postoperatively were 3.0 (1.9) and 3.5 (1.9) in the control and intervention groups, respectively (difference in means, -0.5; 80% confidence interval, -1.4 to 0.5).

Conclusion: This RCT showed the feasibility and safety of the intervention with a high retention to the end of follow-up. Nevertheless, we did not meet our prespecified recruitment target, and the results did not provide evidence of potential effectiveness of the intervention to sufficiently support the conduct of a definitive efficacy RCT.

Study registration: ClinicalTrials.gov ( NCT04860843 ); first posted 27 April 2021.

在椎旁阻滞的基础上增加胸间和胸锯肌筋膜平面阻滞用于全乳切除术和立即乳房重建后的镇痛:一项试点可行性随机对照试验。
目的:乳房切除术后乳房重建(BR)可能与明显的术后疼痛有关。使用区域麻醉阻滞已被确定为一种潜在的有益技术,以减少围手术期疼痛。我们试图进行一项试点可行性试验,以评估在胸椎旁阻滞(tpvb)基础上增加胸间阻滞和胸锯肌阻滞。方法:我们于2021年5月7日至2023年3月17日在普罗维登斯乳房中心(Mount Saint Joseph's Hospital, Vancouver, BC, Canada)进行了一项试点可行性随机对照试验(RCT)。采用组织扩张器或植入物进行BR的成年女性患者随机(1:1)接受TPVB +胸间肌和胸锯肌阻滞(干预)或TPVB +生理盐水(对照组)。可行性结果与招聘、保留、整体管理和安全性有关。我们还测量了术后24小时的数值评定量表(NRS)疼痛评分,并评估组间平均评分差异的80%置信区间(CI)的下限是否为100 0。结果:在83例符合条件的患者中,30例(36%)被随机化。平均每月招募1.3例患者;所有阻滞均成功实施,无并发症发生。随访结束时(6个月)的保留率为90%。对照组和干预组术后24小时自我报告NRS疼痛评分的平均(标准差)分别为3.0(1.9)和3.5(1.9)(均值差异为-0.5;80%置信区间为-1.4 ~ 0.5)。结论:本随机对照试验显示了该干预措施的可行性和安全性,随访结束时保留率高。然而,我们没有达到预定的招募目标,结果也没有提供干预潜在有效性的证据,不足以支持进行明确疗效的随机对照试验。研究注册:ClinicalTrials.gov (NCT04860843);首次发布于2021年4月27日。
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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来源期刊
CiteScore
8.50
自引率
7.10%
发文量
161
审稿时长
6-12 weeks
期刊介绍: The Canadian Journal of Anesthesia (the Journal) is owned by the Canadian Anesthesiologists’ Society and is published by Springer Science + Business Media, LLM (New York). From the first year of publication in 1954, the international exposure of the Journal has broadened considerably, with articles now received from over 50 countries. The Journal is published monthly, and has an impact Factor (mean journal citation frequency) of 2.127 (in 2012). Article types consist of invited editorials, reports of original investigations (clinical and basic sciences articles), case reports/case series, review articles, systematic reviews, accredited continuing professional development (CPD) modules, and Letters to the Editor. The editorial content, according to the mission statement, spans the fields of anesthesia, acute and chronic pain, perioperative medicine and critical care. In addition, the Journal publishes practice guidelines and standards articles relevant to clinicians. Articles are published either in English or in French, according to the language of submission.
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