跳至主要内容
临床试验/NCT04947072
NCT04947072Unknown不适用

Comparison Between Erector Spinae Plane Block and Spinal as Surgical Anesthesia and Analgesia in Percutaneous Nephrolithotomy Patient : Conversion to General Anesthesia, Interleukin-6, Postoperative Pain and Opioid Consumption

Indonesia University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年9月14日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
2
主要终点
Incidence conversion to general anesthesia

研究概览

简要总结

This study aimed to compare the Effectiveness of Erector Spinae plane block to Spinal as a surgical anesthesia and analgesia in Percutaneous Nephrolithotomy patient

详细描述

Thirty subjects (who meet all inclusion criteria and do not have exclusion criteria) are given informed consent before enrolling the study and randomized into two groups: erector spinae plane block and spinal. Non-invasive blood pressure monitor, electrocardiogram (ECG), and pulse-oxymetry will be set on the subjects in the operation room. Peripheral venous blood samples will be taken for IL-6 examination. All patients will be sedated using Target Controlled Infusion with propofol (Schnider model, effect site) to obtain mild-moderate sedation prior to the block. On Erector Spinae Plane group, single-shot ultrasound guided block will be performed on the operated side with stimuplex 100 mm needle and 25 ml of isobaric bupivacaine 0.5% with epinephrine 1:200.000 will be administered at level Th 9. On the Spinal group, spinal anesthesia will be performed on lateral decubitus position at the level of L3-L4 or L4-L5 and hyperbaric bupivacaine 0.5% 16-18 mg will be given as regimen. Prior to urethral manipulation, all subjects will be given fentanyl iv 50 mcg and sedation with TCI Propofol will be maintained throughout the procedure. Sensory loss was evaluated by performing skin clamping with a scalpel at the level of the incision before the surgery. The ESP block was considered successful in providing surgical anaesthesia when there was no movement and significant changes in vital signs during skin clamping and throughout the surgery.

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
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • Age 18 years old and above
  • ASA 1,2 and 3
  • Patient who will undergo elective supine Percutaneous Nephrolithotomy

排除标准

  • Patient who does not agree to be included in the study
  • BMI <18.5 kg/m2 or > 40 kg/m2
  • Patient with single functional kidney
  • Patient who is contraindicated for local anesthetics
  • Patient who has severe heart disorder
  • Patient with communication disability and cognitive disorders
  • Patient with chronic pain with history of high opioid consumption and or alcohol addiction
  • Pregnant patient

结局指标

主要结局

Incidence conversion to general anesthesia

时间窗: intraoperatively

This outcome will be measured based on the concentration of propofol needed throughout the surgery. If the concentration of propofol exceeds 3.5 mcg/ml, anesthesia will be converted to a general anesthesia.

次要结局

  • Interleukin -6 plasma concentration(24 hours after surgery)

研究者

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

Pryambodho Pryambodho

Doctor

Indonesia University

研究点 (2)

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