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临床试验/NCT04474873
NCT04474873Unknown不适用

SHOULD THE ERECTOR SPİNAE PLANE BLOCK BE APPLIED IN THE PAIN MANAGEMENT OF PERCUTANOUS NEPHROLITOTOMY SURGERY?

Ankara City Hospital Bilkent2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2020年3月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
3
试验地点
2
主要终点
Visual Analog Scale

研究概览

简要总结

This study investigates the effectiveness of the erector spinae plane block (ESPB) in pain management of patients undergoing PNL.

详细描述

Although percutaneous nephrolithotomy(PNL) is a minimally invasive procedure, it causes severe postoperative pain due to dilatation of the renal capsule and parenchymal duct and peritubal distension of the nephrostomy tube. PNL-related pain has a limited response to oral and intravenous treatments. The primary aim of our study is to investigate the effectiveness of the erector spinae plane block (ESPB) in pain management of patients undergoing PNL.

Our secondary aim is determining if any possible clinical effect of ESPB in terms of serial peak expiratory flow measurements, postoperative agitation score of the patient (Riker Score), ambulation time, length of hospital stay.

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, Investigator, 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

  • patients undergoing PNL between 18-65 years old

排除标准

  • serious cardiac, respiratory, hepatic, renal or haemotologic disease
  • mental disorder and hearing problem
  • anxiety, depression and / or other psychiatric disorders
  • pregnancy
  • refusal of patient
  • Allergy or contraindications to drugs used in the study
  • ASA > 2 Inflammation or infection over injection site Obese patients BMI ≥35/

结局指标

主要结局

Visual Analog Scale

时间窗: postoperative 24 hours

the amount of pain that a patient feels ranges across a continuum from none(0) to an extreme amount of pain(10) on a chart.

Dynamic Visual Analog Scale

时间窗: postoperative 24 hours

the amount of pain during mobilization, deep breathing or coughing that a patient feels ranges across a continuum from none(0) to an extreme amount of pain(10) on a chart

Peak Expiratory Flow Rate( PEFR)

时间窗: postoperative 24 hours

maximum speed of expiration as measured with a peak flow meter

次要结局

  • nausea and vomiting(24 hours)
  • ambulation time(5 days)
  • length of hospital stay(1 week)
  • Rikert Agitation Scale(24 hours)
  • Time for first analgesic requirement(24 hours)
  • patient satisfaction with anesthesia and analgesia(24 hour)
  • starting oral intake(48 hours)
  • urinary catheter releated pain score(Visual Analog Scale)(postoperative 24 hours)
  • surgeon satisfaction with anesthesia and analgesia(24 hour)

研究者

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

semih başkan

assistant professor

Ankara City Hospital Bilkent

研究点 (2)

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