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临床试验/NCT03520205
NCT03520205已完成不适用

Comparison Between Quadratus Lumborum Block and Epidural on Stress Response and Perioperative Cellular Immunological Function of Laparoscopic Nephrectomy Kidney Donor

Indonesia University2 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2018年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
62
试验地点
2
主要终点
Change from Baseline Interleukin-6 at 24 hours after abdominal insufflation

研究概览

简要总结

This study aimed to compare Quadratus Lumborum Block to Epidural on Stress Response and Perioperative Cellular Immunological Function of Laparoscopic Nephrectomy Kidney Donor

详细描述

Sixty-two subjects were given informed consent before enrolling the study and randomized into two groups; quadratus lumborum block and epidural. Non-invasive blood pressure monitor, electrocardiogram (ECG), and pulse-oxymetry were set on the subjects in the operation room. General anesthesia induction was done by fentanyl 2 mcg/kg and propofol 1-2 mg/kg. Endotracheal tube (ETT) intubation was facilitated with Atracurium 0.5mg/kg as muscle relaxant. Maintenance was done by sevoflurane, oxygen, and compressed air. On quadratus lumborum block group, bilateral block using ultrasound will be performed with stimuplex 100mm needle with 20 cc of bupivacaine 0.25% as regimen. On epidural group, epidural catheter was inserted under general anaesthesia on left lateral decubitus position (5 cm depth inside the epidural space) at level Th10-Th11. The catheter insertion was confirmed with vacuum aspiration and negative test-dose. Before first incision, patient will be given continuous epidural Bupivacaine 0.25% 6 mL/hour. Blood sample was drawn for interleukin-6, blood glucose, and c-reactive protein as baseline data. After surgery, patient were extubated until fully conscious and can follow command verbally. Patient will be transported in recovery room post operation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Kidney donor patients undergoing laparoscopic nephrectomy
  • Body mass index below 30
  • Duration of surgery 4 to 6 hours
  • Patients who agreed to participate in this study and sign informed consent.

排除标准

  • Have contraindication for quadratus lumborum block
  • Have contraindication for epidural
  • Previous history of local anesthetic drug allergy
  • inability to communicate

研究组 & 干预措施

Quadratus Lumborum Block

Active Comparator

Patient will receive quadratus lumborum block

干预措施: Quadratus Lumborum Block (Procedure)

Continuous Epidural

Active Comparator

Patient will receive epidural anesthesia

干预措施: Continuous Epidural (Procedure)

结局指标

主要结局

Change from Baseline Interleukin-6 at 24 hours after abdominal insufflation

时间窗: Before procedure, at the end of surgery, and 24 hours after abdominal insufflation

Measure by ELISA

Cumulative morphine requirement at 2 hours, 6 hours, 12 hours, 24 hours postoperative

时间窗: 2 hours, 6 hours, 12 hours, 24 hours.

Cumulative morphine consumption at each time point in 24 hours after surgery

次要结局

  • Duration of urinary catheter(24 hours)
  • Change from Baseline Pain Intensity at 2, 6, 12, and 24 hours after procedure(2, 6, 12, and 24 hours after procedure)
  • Total bupivacaine used in 24 hours(24 hours)
  • Change from Baseline Patient Controlled Analgesia at 2, 6, 12 and 24 hours after procedure(2, 6, 12, and 24 hours after procedure)
  • Change from Baseline Blood Glucose at 2 hours after abdominal insufflation(Before procedure and 2 hours after abdominal insufflation)
  • Change from Baseline Cardiac Index(Intraoperative and 24 hours)
  • Change from Baseline hs-CRP at 48 hours after abdominal insufflation(Before procedure, at the end of surgery, and 48 hours after abdominal insufflation)
  • Time to first morphine requirement(24 hours)
  • Change from Baseline Blood pressure(Intraoperative and 24 hours)
  • Change from Baseline Heart Rate(Intraoperative and 24 hours)
  • Number of participants with paresthesia after procedure(24 hours)
  • Level of sensory block after procedure(24 hours)
  • Change from Baseline Mean Arterial Pressure(Intraoperative and 24 hours)
  • Change from baseline motor block at 2, 6, 12, and 24 hours after anesthesia recovery(2, 6, 12, and 24 hours after procedure)

研究者

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

Aida Rosita Tantri

Anesthesiologist Consultant

Indonesia University

研究点 (2)

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