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临床试验/NCT05845281
NCT05845281已完成不适用

Comparison of Erector Spina Plane Block and Intravenous Patient-controlled Analgesia in Patients Undergoing Percutaneous Nephrolithotomy

Yuzuncu Yıl University2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2022年2月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
2
主要终点
Post operative analgesia

研究概览

简要总结

The primary purpose of this study was to compare the effects of erector spinal plane block (ESP) and IV patient-controlled analgesia (PCA) performed to provide analgesia in percutaneous nephrolithotomy surgeries on visual analog skala (VAS), additional analgesia need, patient satisfaction and mobilization times.

详细描述

ASA I-III patients aged 18-65 years who underwent percutaneous nephrolithotomy at Van Yüzüncü Yıl University Faculty of Medicine were included in the study.

The patients were informed about the study during the preoperative evaluation. In the randomized single-blind closed-envelope study, 30 patients ineach group and a total of 60 patients were included. Standard general anesthesia procedure was applied to all patients. Standard general anesthesia procedure was applied to all patients. Perioperative hemodynamic monitoring was performed. In patients who underwent general anesthesia, after the surgical procedure was completed, after sterility was ensured for the ESP group while the patient was in the lateral position for the ESPB procedure, the linear 10-18 MHz USG probe (Esaote MyLab 30, Geneva, Italy) was placed between two transverse processes in the paramedian plane and increased from 1mg/kg to %1 at the T7 level. 20 ml of 0.5 bupivacaine (Buvasin®, Vem, Istanbul, Turkey) + 2% arrhythmic residual SF from 1mg/kg was administered. For patients in the PCA group, 200 mg of tramadol was placed in 100cc of 0.9% NaCl. Set to PCA device. A 50mg loading dose was administered 10 minutes before the patient was extubated. After extubating, a bolus dose of 20 mg was started, with a 30-minute lock-in time, and an infusion dose of 5mg/hour. The 4-hour maximum limit was set to 200 mg.

VAS score, need for additional analgesia, patient satisfaction (Likert scale), mobilization times and vital signs were recorded at 30 minutes, p1, 3, 6 and 12 hours after 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
Single (Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologists (ASA) class I-III,
  • Between 18-65 years old,
  • Percutaneous nephrolithotomy surgery,
  • Patients who agreed to participate in the study

排除标准

  • Obesity (BMI≥ 35)
  • Coagulopathy
  • Active Infection
  • Drug allergies
  • Pregnancy
  • 65 years and older

结局指标

主要结局

Post operative analgesia

时间窗: 24 hours

Visual Analog Scale score were recorded at the post operative 30 minutes, 1st, 3rd, 6th and 12th hours after the operation. High VAS score was interpreted as severe pain in patients. When the VAS score was 4 and above, additional analgesic (15 mg/kg paracetamol) was given intravenously.

Additional analgesic drug

时间窗: 24 hours

When the VAS score was 4 and above, 15 mg/kg paracetamol was given intravenously. Additional analgesic drug (Paracetamol) was recorded in milligrams.

Patient satisfaction

时间窗: 24 hours

Patient satisfaction was recorded using a Likert scale at the 30th minute, 1st, 3rd, 6th and 12th hours after the operation. Patient satisfaction was scored between 1 and 5 using a Likert scale at the 30th minute, 1st, 3rd, 6th and 12th hours postoperatively. 1 point not satisfied at all, 2 points dissatisfied, 3 points not sure, 4 points satisfied, 5 points very satisfied.

First walking time after surgery

时间窗: 24 hours

Mobilization status was checked and recorded at the 30th minute, 1st, 3rd, 6th and 12th hours after the surgery. We accepted the extubation time as the postoperative 0th hour. We determined the time when the patients started walking for the first time after the surgery accordingly.

次要结局

未报告次要终点

研究者

发起方
Yuzuncu Yıl University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hacı Yusuf Güneş, MD

Assistant proffesor

Yuzuncu Yıl University

研究点 (2)

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