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临床试验/NCT03376048
NCT03376048已完成不适用

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

Kyungpook National University Hospital4 个研究点 分布在 2 个国家目标入组 108 人开始时间: 2017年12月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
108
试验地点
4
主要终点
Pain numerical rating scale (NRS)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Pain numerical rating scale (NRS)

时间窗: 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"

次要结局

  • Pain NRS(12, 24, 36, 48, 72 hour after surgery)
  • Rescue opioid analgesic requirement(postoperative day 0, 1, 2, 3)
  • Postoperative nausea and vomiting scale(12, 24, 36, 48, 72 hour after surgery)
  • Time to first oral fluid intake(8 weeks after surgery)
  • Occurrence of prolonged post-operative ileus(8 weeks after surgery)
  • Time to first oral soft diet(8 weeks after surgery)
  • Length of hospital stay(8 weeks after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Soo Yeun Park

Colorectal Cancer Center, Kyungpook National University Chilgok Hospital

Kyungpook National University Hospital

研究点 (4)

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