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临床试验/NCT03966599
NCT03966599已完成不适用

Comparison of Hemodynamic Stability and Pain Control Between Two Anesthesia Positions of Lateral and Prone in Patients Undergoing Percutaneous Nephrolithotomy; a Randomized Controlled Trial Study

Isfahan University of Medical Sciences0 个研究点目标入组 50 人开始时间: 2016年4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
50
主要终点
pain intensity in VAS score and need for analgesics in milligram

研究概览

简要总结

This study was designed to evaluate whether patient position (lateral vs. prone) has affect on the need for analgesia and onset of pain after surgery.

详细描述

Percutaneous Nephrolithotomy is the preferred surgical treatment in many cases of kidney stones which is performed in different positions such as prone, lateral, and supine. However, we do not have enough evidence comparing prone and lateral positioning regarding the need for analgesia and onset of pain after surgery. This study was designed to evaluate whether patient position (lateral vs. prone) has affect on the need for analgesia and onset of pain after surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

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

  • Inclusion criteria were age between 18-65 years,
  • having kidney stones; consent for spinal anesthesia,
  • ASA classes (American Society of Anesthesiologists class) of 1 and 2 (patients without any cardiovascular or respiratory disorders)
  • superior and median ureter larger than 20 mm in diameter.

排除标准

  • those with coagulation defects,
  • severe pain requiring more than one dose of fentanyl,
  • considerable rise of blood pressure or heart rate during the operation.

研究组 & 干预措施

Lateral position

Active Comparator

The patient position was changed to lateral during surgery

干预措施: Pain (Diagnostic Test)

Lateral position

Active Comparator

The patient position was changed to lateral during surgery

干预措施: Hemodynamic changes (Diagnostic Test)

prone position

Active Comparator

The patient position was changed to prone during surgery

干预措施: Pain (Diagnostic Test)

prone position

Active Comparator

The patient position was changed to prone during surgery

干预措施: Hemodynamic changes (Diagnostic Test)

结局指标

主要结局

pain intensity in VAS score and need for analgesics in milligram

时间窗: at one year after surgery

determining pain with visual analogue scale (VAS) and need for analgesics (milligram) in lateral versus prone position. The visual analogue scale (VAS) is usually presented as a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable." Its simplicity, reliability, and validity, as well as its ratio scale properties, make the VAS the optimal tool for describing pain severity or intensity.

次要结局

  • hemodynamic state(at one year after surgery)

研究者

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

Hamidreza Shemshaki

Director

Isfahan University of Medical Sciences

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