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临床试验/NCT04635644
NCT04635644已完成不适用

Ultrasound Guided Erector Spinae Block Versus Intrathecal Morphine for Postoperative Analgesia in Major Hepatopancreaticobiliary Surgery

Assiut University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Cumulative opioid consumption

研究概览

简要总结

To compare the efficacy of USG-guided bilateral Erector spinae plane block (ESPB) with intrathecal morphine (ITM) for postoperative analgesia after major hepatopancreaticobiliary surgery (HPB)

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
Triple (Participant, Care Provider, 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

  • Age between 18 and 65 years with a body mass index (BMI) of 18-35 kg/m2,
  • patients with the American Society of Anesthesiologists (ASA) physical status I - II,
  • Patients scheduled for elective major hepatopancreaticobiliary surgery for benign or malignant disease; major surgery is defined as an operation of anticipated duration of more than one hour.

排除标准

  • Patient's refusal
  • Allergy or contraindications to the study drugs,
  • Infection at the site of injection,
  • Coagulopathy,
  • Psychiatric disorders
  • Severely co-morbid patients,
  • Chronic pain syndromes,
  • Prolonged opioid medication,

结局指标

主要结局

Cumulative opioid consumption

时间窗: 24 hours postoperatively

Nalbuphine consumption in mg equivalent to morphine dose

次要结局

  • Analgesic drug consumption other than nalbuphine(at 8, 24, 48, and 72 hours postoperatively.)
  • Numerical Rating Scale (NRS) at rest and when coughing(at 1, 2, 4, 8, 12, 24, 48 and 72 hours postoperatively)
  • Heart Rate(Intraoperatively)
  • Incidence of Postoperative nausea & vomiting (PONV)(24 hours postoperatively)
  • Nalbuphine consumption in mg(at 8, 48, and 72 hours postoperatively.)
  • Mean Arterial Pressure(Intraoperatively)

研究者

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

Magdy Mohammed Mahdy Sayed

Principal Investigator

Assiut University

研究点 (2)

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