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临床试验/NCT07672600
NCT07672600已完成不适用

The Effect of Ultrasound-Guided Erector Spinae Plane Block on Postoperative Analgesia in Percutaneous Nephrolithotomy: a Randomised Single-blind Trial

Istanbul University1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2019年10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
56
试验地点
1
主要终点
Total 24-hour morphine consumption

研究概览

简要总结

This study is planned as a single-center randomized single blinded study and includes patients undergoing percutaneous nephrolitotomy.The aim of the study is to evaluate the effect of ultrasound guided erector spinal plane block on postoperative analgesia in percutaneous nephrolitotomy. Primary outcome is the total 24 hour morphine consumption.

详细描述

Adult patients aged 18-65 years with American Society of Anesthesiologists (ASA) physical status I-II scheduled for elective PCNL were allocated to receive either a unilateral ultrasound-guided ESPB at the T9 level with 20 mL of 0.25% bupivacaine followed by postoperative IV morphine PCA (Group ESPB ) or postoperative IV morphine PCA alone (Group C). 24 hour morphine consumption, numeric Rating Scale (NRS) pain scores, rescue analgesic requirements, sedation scores, opioid-related adverse effects, hospital stay, chronic pain, patient and surgeon satisfaction are recorded.

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 (Care Provider, 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

  • Elective percutaneous nephrolitotomy
  • American Society of Anesthesiologists (ASA) physical status I-II

排除标准

  • Refusal to participate
  • Coagulopathy,
  • Infection at the block site
  • Allergy to local anaesthetics
  • Previous surgery in the block area
  • Severe systemic disease.

研究组 & 干预措施

Group erector spinae plane block (Group ESPB)

Active Comparator

Patients received erector spinae plane block for postoperative analgesia

干预措施: Erector Spinae Plane Block (Procedure)

Group Control (Group C)

Active Comparator

Patients received only intravenous analgesia

干预措施: Intravenous analgesia (Procedure)

结局指标

主要结局

Total 24-hour morphine consumption

时间窗: 24 hours

Total 24-hour intravenous morphine consumption via patient controlled analgesia device

次要结局

  • Pain assessment(24 hours)
  • Additional analgesic requirement(24 hours)
  • Postoperative nausea and vomiting(24 hours)
  • Patient satisfaction(Up to 24 hours)
  • Surgeon satisfaction(Up to 24 hours)
  • First rescue analgesic time(24 hours)
  • Length of hospital stay(Up to 1 week)
  • Pruritus(24 hours)
  • Chronic pain(3 months)

研究者

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

Meltem Savran Karadeniz

Attending Anesthesiologist

Istanbul University

研究点 (1)

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