Mesh : Humans Laparoscopy / methods Nerve Block / methods Gastrectomy / methods Levobupivacaine / administration & dosage Pain, Postoperative / prevention & control drug therapy Single-Blind Method Anesthetics, Local / administration & dosage pharmacokinetics Intercostal Nerves Female Middle Aged Male Aged Adult Randomized Controlled Trials as Topic Treatment Outcome

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Abstract:
OBJECTIVE: A novel external oblique intercostal block (EOIB) might have analgesic effects on T6-10 and be indicated for laparoscopic gastrectomy. However, EOIB effects on postoperative pain are unknown. We aim to generate evidence to support such EOIB application. We will compare the efficacy of EOIB and wound infiltration (WI) in a single-center, single-blind, randomized controlled trial.
METHODS: We will assess plasma concentrations of levobupivacaine after EOIB, its pharmacokinetics, and the pinprick test in patients randomly assigned to receive EOIB or WI before laparoscopic or robot-assisted gastric distal or total gastrectomy. The EOIB and WI will start after general anesthesia induction with 20 and 40 mL of 0.25% levobupivacaine per side, respectively, before skin closure. The outcomes will be numeric rating scale (NRS) scores at 12 h postoperatively (primary) and postoperative NRS scores at 2, 24, and 48 h; fentanyl application; QoR-15 scores on postoperative days 1, 2, and 7; and World Health Organization Disability Assessment Schedule 2.0 scores at 3 months (secondary).
CONCLUSIONS: We hope that our study will provide evidence to support EOIB application in laparoscopic surgery. Plasma concentrations will help determine levobupivacaine pharmacokinetics, which if similar to conventional nerve blocks, will indicate EOIB\'s safety.
摘要:
目的:一种新型外斜肋间阻滞(EOIB)可能对T6-10有镇痛作用,适用于腹腔镜胃切除术。然而,EOIB对术后疼痛的影响尚不清楚。我们的目标是生成证据来支持这种EOIB应用。我们将比较EOIB和伤口浸润(WI)在单中心的疗效,单盲,随机对照试验。
方法:我们将评估EOIB后左旋布比卡因的血浆浓度,其药代动力学,以及在腹腔镜或机器人辅助的远端胃切除术或全胃切除术前随机分配接受EOIB或WI的患者的针刺试验。EOIB和WI将在全身麻醉诱导后开始,每侧20和40毫升0.25%左布比卡因,分别,皮肤闭合前。结果将是术后12小时的数字评定量表(NRS)评分(主要)和术后2、24和48小时的NRS评分;芬太尼应用;术后第1、2和7天的QoR-15评分;以及3个月时的世界卫生组织残疾评估计划2.0评分(次要)。
结论:我们希望我们的研究将提供证据支持EOIB在腹腔镜手术中的应用。血浆浓度将有助于确定左布比卡因的药代动力学,如果类似于传统的神经阻滞,将表明EOIB的安全性。
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