此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Local Wound Infiltration Plus TAP Block Versus Local Wound Infiltration Only

2020年2月4日 更新者:Soo Yeun Park、Kyungpook National University Hospital

Comparison of Analgesic Efficacy of Local Wound Infiltration Plus Transversus Abdominis Plane Block and Local Wound Infiltration Only After Laparoscopic Colorectal Resection: a Randomized, Double-blind, Non-inferiority Trial

The TAP block is typically performed either with ultrasound guidance (TAP-US) or laparoscopic visualization (TAP-LAP): comparison between these two technics showed no differences in pain control and use of opioid analgesics.

The investigators hypothesize that WI is non-inferior to WI + TAP-block with respect to postoperative pain.

研究概览

详细说明

In colorectal surgery, laparoscopy and enhanced recovery after surgery (ERAS) programs have significantly improved the short-term outcomes (1). Although the laparoscopic approach reduces pain and recovery time, post-operative pain, nausea and vomiting still represent an issue. In order to reduce opioid related side effects, such as postoperative nausea and vomiting (PONV), constipation and prolonged post-operative ileus, non-opioid based multimodal analgesia have been recently introduced. Although epidural analgesia has gained good success, it does not seem to offer any additional clinical benefits to patients undergoing laparoscopic colorectal surgery compared to alternative analgesic technique within an ERAS program. Both local wound infiltration (WI) and TAP block are common techniques in multimodal postoperative pain treatment, and their association allows to achieve pain control despite a reduced use of opioid analgesics. Furthermore, in a recent single-blind prospective study TAP block resulted superior to wound infiltration alone. The TAP block is typically performed either with ultrasound guidance (TAP-US) or laparoscopic visualization (TAP-LAP): comparison between these two technics showed no differences in pain control and use of opioid analgesics.

The aim of this study is to compare WI + TAP-LAP versus WI alone. The investigators hypothesize that WI is non-inferior to WI + TAP-block with respect to postoperative pain.

研究类型

介入性

注册 (实际的)

108

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Daegu、大韩民国、41404
        • Kyungpook National University Chilgok Hospital
      • Verona、意大利、37134
        • University of Verona Hospital Trust and Colorectal Cancer Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 80年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Aged 18-80 years, either sex
  • Patients scheduled to undergo elective laparoscopic colorectal surgery under general anesthesia
  • Willingness and ability to sign an informed consent document

Exclusion Criteria:

  • Allergies to anesthetic or analgesic medications
  • Contraindication to the use of locoregional anesthesia
  • Chronic opioid use
  • Coagulopathy, Impaired kidney function, uncontrolled diabetes, psychiatric disorders, severe cardiovascular impairment or chronic obstructive lung disease
  • Necessity of major resection other than colorectal, palliative surgery
  • BMI above 35 kg/m2
  • American Society of Anesthesiologists (ASA) physical status above 3

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:三倍

武器和干预

参与者组/臂
干预/治疗
实验性的:Wound infiltration plus TAP
Wound infiltration placed by surgeon + TAP-LAP placed laparoscopically guided by surgeon
  1. TAP block: At the beginning of the main surgical procedure the surgeon will perform a TAP with ropivacaine infiltration, bilaterally in the anterior axillary line, between the costal margin and iliac crest in the intermuscular plane between the internal oblique and transversus abdominis muscles, the anesthesiologist under ultrasound guidance, the surgeon under laparoscopic guidance (two "pops" technique).
  2. Wound infiltration : Wound infiltration of ropivacaine will be performed by the surgeon before skin incision.
其他名称:
  • 罗哌卡因
有源比较器:Wound infiltration
Wound infiltration placed by surgeon
Wound infiltration of ropivacaine will be performed by the surgeon before skin incision.
其他名称:
  • 罗哌卡因

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Pain numerical rating scale (NRS)
大体时间:within the first 6 hours after surgery
  1. Pain NRS during rest and cough
  2. NRS scale 0-10: 0, "no pain"; 10, "worst pain imaginable"
within the first 6 hours after surgery

次要结果测量

结果测量
措施说明
大体时间
首次口服液体摄入时间
大体时间:术后8周
手术后首次口服液体的时间
术后8周
第一次口服软食的时间
大体时间:术后8周
手术后第一次口服软食的时间
术后8周
住院时间
大体时间:术后8周
入院后住院时间
术后8周
Pain NRS
大体时间:12, 24, 36, 48, 72 hour after surgery
  1. Pain NRS during rest and cough
  2. NRS scale 0-10: 0, "no pain"; 10, "worst pain imaginable"
12, 24, 36, 48, 72 hour after surgery
Rescue opioid analgesic requirement
大体时间:postoperative day 0, 1, 2, 3
Overall postoperative rescue of opioid analgesic requirement described by using the Defined Daily Dose
postoperative day 0, 1, 2, 3
Postoperative nausea and vomiting scale
大体时间:12, 24, 36, 48, 72 hour after surgery
PONV scores (assessed using a 0 - 2 categorical scale; no nausea/ nausea/ vomiting)
12, 24, 36, 48, 72 hour after surgery
Occurrence of prolonged post-operative ileus
大体时间:8 weeks after surgery
Occurrence of prolonged post-operative ileus (assessed using a 0 - 1 categorical scale; no ileus/ileus)
8 weeks after surgery

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Soo Yeun Park, MD、Kyungpook National University Chilgok Hospital
  • 首席研究员:Corrado Pedrazzani, MD、University of Verona Hospital Trust and Colorectal Cancer Center

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年12月20日

初级完成 (实际的)

2019年4月30日

研究完成 (实际的)

2019年12月30日

研究注册日期

首次提交

2017年12月12日

首先提交符合 QC 标准的

2017年12月15日

首次发布 (实际的)

2017年12月18日

研究记录更新

最后更新发布 (实际的)

2020年2月5日

上次提交的符合 QC 标准的更新

2020年2月4日

最后验证

2020年2月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅