Comparison of Analgesic Efficacy of Quadratus Lumborum Block With Local Anesthesia and Quadratus Lumborum Block With Placebo Only After Ileostomy Repair: a Randomized, Double-blind, Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Pain numerical rating scale (NRS)
研究概览
简要总结
Opioid analgesics have many side effects. Quadratus lumborum (QL) block is one kind of regional nerve block that can reduce the side effects of opioid analgesics. The investigators hypothesize that QL block with local analgesics (ropivacaine) can significantly reduce pain intensity in comparison with placebo.
详细描述
Opioid analgesics have been used to control the pain. However, many postoperative complication, such as nausea, vomiting, constipation, ileus, etc are related to opioid usage. Recently, local or regional pain nerve block, such as transversus abdominis plane block, wound infiltration, have been reported in several studies. Quadratus lumborum (QL) block was first introduced in the abstract of 2007 European Society of Regional Anesthesia. The effect is longer and more than that of transversus abdominis plane block because it works close to the spinal cord nerves. The QL block can be an effective pain control method for patients who underwent ileostomy closure. The aim of this study is to compare pain intensity after ileostomy closure between QL block (ropivacaine) group and placebo group (normal saline).
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 20-75 years, either sex
- •Patients scheduled to undergo elective ileostomy repair surgery under general anesthesia.
- •Patients underwent curative surgery and ileostomy due to colorectal cancer.
- •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 35kg/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: 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(2, 12,24,36,48,72 hour after surgery)
- Rescue opioid analgesic requirement(postoperative day 0,1,2,3)
- Postoperative nausea and vomiting scale(2, 12,24,36,48,72 hour after surgery)
- Occurrence of prolonged post-operative ileus(8 weeks after surgery)
- Time to first oral fluid intake(8 weeks after surgery)
- Length of hospital stay(8 weeks after surgery)
- Time to first oral soft diet(8 weeks after surgery)
研究者
Soo Yeun Park
Principal Investigator
Kyungpook National University Hospital