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首页> 外文期刊>Trials >Transmuscular quadratus lumborum block versus thoracic paravertebral block for acute pain and quality of recovery after laparoscopic renal surgery: study protocol for a randomized controlled trial
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Transmuscular quadratus lumborum block versus thoracic paravertebral block for acute pain and quality of recovery after laparoscopic renal surgery: study protocol for a randomized controlled trial

机译:经肌四头肌腰椎阻滞与胸椎旁阻滞治疗腹腔镜肾脏手术后的急性疼痛和恢复质量:一项随机对照试验的研究方案

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Quadratus lumborum block (QLB) is increasingly gaining popularity as a novel abdominal truncal block in abdominal surgery; however, the mechanism of QLB is not yet thoroughly illustrated. The focus of our study is transmuscular QLB (TMQLB), as the latest anatomical evidence shows that anesthetics spread into the thoracic paravertebral space to exert an analgesic effect. Therefore, we designed this study to compare TMQLB with thoracic paravertebral block (TPVB) in laparoscopic renal surgery in the hope of providing clinical evidence on the analgesic mechanism of TMQLB and its application in laparoscopic renal surgery. This trial is a prospective, randomized, single-center, open-label, parallel, three-arm, non-inferiority trial. We intend to include 120 participants undergoing laparoscopic nephrectomy and before surgery they will be randomized into three groups for postoperative pain control: TMQLB experimental group 1 (0.4?ml/kg body weight 0.5% ropivacaine), TMQLB experimental group 2 (0.6?ml/kg body weight 0.5% ropivacaine) or TPVB control group (0.4?ml/kg body weight 0.5% ropivacaine at vertebra T10). Patients will be excluded if they have allergy to anesthetics, infection at the injection site, are on coagulopathy or anticoagulants, on analgesics for chronic illness, have history of substance abuse or have a barrier to communication. Morphine is given in boluses of 1.5~2?mg by intravenous patient-controlled analgesia (IPCA) in the first 48?h after surgery. The primary outcome is the difference between TMQLB group 1 and the TPVB group in the mean visual analogue scale (VAS) pain score in the first 24?h after surgery. Secondary outcomes are the difference between TMQLB group 2 and the TPVB group in the mean VAS score in the first 24?h after surgery, cumulative morphine consumption, long-term pain control, dermatomal distribution of sensory loss, nausea score, pruritus score, ambulation time, time till recovery of bowel movement, quality of recovery, postoperative length of hospital stay and patient satisfaction with anesthesia. Safety data on procedure-related complications will also be summarized. This will the first randomized controlled trial to compare TMQLB with TPVB for analgesia in laparoscopic surgery. This trial aims to provide important clinical evidence to elaborate on the analgesic mechanism of TMQLB. ClinicalTrials.gov, NCT03414281 . Registered on 9 January 2018.
机译:腰椎方形阻滞(QLB)作为一种新型的腹部手术性腹部截骨术正越来越受到人们的欢迎。但是,尚未完全阐明QLB的机制。我们的研究重点是跨肌肉QLB(TMQLB),因为最新的解剖学证据表明麻醉剂会扩散到胸椎旁间隙以发挥镇痛作用。因此,我们设计本研究以将TMQLB与胸椎旁椎体阻滞(TPVB)在腹腔镜肾脏手术中进行比较,以期为TMQLB的止痛机理及其在腹腔镜肾脏手术中的应用提供临床证据。该试验是一项前瞻性,随机,单中心,开放标签,平行,三臂,非劣效性试验。我们打算包括120名接受腹腔镜肾切除术的参与者,在手术前,他们将被随机分为三组进行术后疼痛控制:TMQLB实验组1(0.4?ml / kg体重0.5%罗哌卡因),TMQLB实验组2(0.6?ml /公斤体重0.5%罗哌卡因)或TPVB对照组(椎体T10处0.4?ml /公斤体重0.5%罗哌卡因)。如果患者对麻醉剂过敏,在注射部位感染,患有凝血病或抗凝药,患有慢性疾病的镇痛药,有药物滥用史或有沟通障碍,则将被排除在外。术后第一个48小时内,通过静脉自控镇痛(IPCA)以1.5〜2?mg的剂量给予吗啡。主要结果是TMQLB组1和TPVB组在术后24小时内的平均视觉模拟评分(VAS)疼痛评分上的差异。次要结局是TMQLB组2与TPVB组之间在术后24小时内的平均VAS评分,累计吗啡消耗量,长期疼痛控制,感觉损失的皮肤分布,恶心评分,瘙痒评分,行走能力的差异排便恢复的时间,时间,恢复的质量,术后住院时间和患者对麻醉的满意度。与手术相关的并发症的安全性数据也将被汇总。这将是第一个比较TMQLB和TPVB在腹腔镜手术中镇痛效果的随机对照试验。该试验旨在提供重要的临床证据,详细阐述TMQLB的镇痛作用。 ClinicalTrials.gov,NCT03414281。 2018年1月9日注册。

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