切口前头皮阻滞对选择性开颅切除肿瘤成人患者术中阿片类药物消耗的影响:随机双盲试验研究方案

P. Pin-on, Yodying Punjasawaswong
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引用次数: 0

摘要

背景:头皮阻滞是一种选择性神经阻滞技术,用于抑制来自支配头皮的神经的传入输入,包括头皮前部的滑车上神经、眶上神经、颧面神经和颧颞神经。枕大神经和枕小神经支配头皮后部。方法/设计:本研究是一项前瞻性、随机、双盲、安慰剂对照试验,旨在研究计划行幕上开颅手术切除肿瘤的成年患者行切口前头皮阻滞0.5%布比卡因的益处。主要结果将是接受0.5%布比卡因头皮前部阻滞和接受生理盐水溶液的患者术中芬太尼用量的差异。次要结果将是血流动力学的变化,从术前基线颅骨针插入和时间从手术结束到成功拔管。讨论:颅骨钉插入被认为是开颅前最强的刺激。先前的研究结果对头皮阻滞作为一种先发制人的镇痛技术的优势尚无定论。本研究将填补这一知识空白,并检查该技术是否值得作为标准技术执行。试验注册:ClinicalTrials.gov标识符:NCT02057367;于2014年2月注册。伦理:本研究方案经泰国清迈大学Maharaj Nakorn清迈医院伦理委员会批准(批准号:ANE-2556-01510),并将按照《赫尔辛基宣言》执行。知情同意:在纳入本研究之前,将获得参与者的书面知情同意。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Effect of pre-incisional anterior scalp block on intraoperative opioid consumption in adult patients undergoing elective craniotomy to remove tumor: study protocol for a randomized double-blind trial
Background: Scalp block is a selective nerve block technique to inhibit the afferent input from nerves that innervate the scalp, including supratrochlear, supraorbital, zygomaticofacial, and zygomaticotemporal nerves for the anterior scalp. The greater and lesser occipital nerves innervate the posterior scalp. Methods/Design: This study is a prospective, randomized, double-blind, placebo-controlled trial, which will be performed to examine the benefits of a pre-incisional anterior scalp block with 0.5% bupivacaine in adult patients who are scheduled for supratentorial craniotomy to remove tumor. Primary outcome will be the difference of intraoperative fentanyl consumption between patients who receive anterior scalp block with 0.5% bupivacaine and those who receive normal saline solution administration. Secondary outcomes will be the hemodynamic changes from preoperative baseline at a skull pin insertion and the time from the end of surgery to successful extubation. Discussion: Skull pin insertion is known as the strongest stimulus prior to craniotomy. The results from previous studies are inconclusive regarding the advantage of scalp block as a pre-emptive analgesic technique. This study will fill this knowledge gap, and examine whether this technique is worth performing as a standard technique. Trial registration: ClinicalTrials.gov identifier: NCT02057367; registered in February 2014. Ethics: This study protocol was approved by the Ethics Committee of Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University, Thailand (approval number: ANE-2556-01510) and will be performed in accordance with the Declaration of Helsinki. Informed consent: Written informed consent will be obtained from participants prior to inclusion in this study.
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