Analgesic Effect of Quadratus Lumborum Block in Laparoscopic Hemicolectomy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- NRS (Numeric rating scale)
研究概览
简要总结
Comparison of the effectiveness: Quadratus lumborum (QL) block by levobupivacaine with placebo.
详细描述
All patients will receive standard anaesthesia using fentanyl, protocol, cisatracurium and sevoflurane. Prevention of nausea and vomiting is performing using Apfel score.
All patients will receive post operative multimodal analgesia using paracetamol, ketoprofen, tramadol, and trimeperidine if numerical rating scale > 3 The study assumes use of QL block by levobupivacaine.in comparison with placebo in order to demonstrate the effectiveness of QL block during the operation.
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, Care Provider, Outcomes Assessor)
盲法说明
Triple blindness. The Principal Investigator performing the blockade knows the randomization group. The anesthesiologist, postoperative pain assessor, and study participant do not know the randomization group.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have undergone left-sided or right-sided laparoscopic hemicolectomy.
- •Patient's willingness and ability to sign an informed consent document
排除标准
- •Allergy to local anesthetics
- •Chronic pain syndrome and associated opioid use.
- •Coagulopathy
- •Uncontrolled diabetes mellitus
- •Physical Status Classification System scale above 3
- •Diseases associated with the pathology of the hypothalamus
- •Diseases associated with the pathology of the pituitary gland
- •Diseases associated with the pathology of the adrenal glands
结局指标
主要结局
NRS (Numeric rating scale)
时间窗: two hours after surgery
NRS scale 0-10, "no pain"; 10, "worst pain imaginable"
次要结局
- The need for antiemetic drugs to relieve postoperative nausea and vomiting(12 hours after the surgery)
- Occurrence of prolonged post-operative ileus(first two weeks after surgery)
- The need for opioid analgesics for postoperative pain relief(72 hours after surgery)
- Blood glucose level(after induction into anesthesia, immediately after the end of the surgery, 12 hours after the surgery)
- The need for opioid analgesics during surgery(on operations)
- The level of prolactin in the blood(after induction into anesthesia and immediately after the end of the surgery.)
- The level of blood lactate(after induction into anesthesia, immediately after the end of the surgery, 12 hours after the surgery)
- The level of cortisol in the blood(after induction into anesthesia and immediately after the end of the surgery)
研究者
Evgenii Bespalov,MD
Doctor of the department of anesthesiology and resuscitation
Petrovsky National Research Centre of Surgery