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临床试验/NCT03885583
NCT03885583已完成不适用

Evaluation of Post-operative Pulmonary Function After Open Kidney Surgery: Comparison Between Thoracic Epidural and Paravertebral Block

Assiut University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年5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
试验地点
1
主要终点
vital capacity

研究概览

简要总结

To assess the respiratory and analgesic effects of continuous thoracic paravertebral block versus thoracic epidural in patients undergoing kidney surgery

详细描述

Study tools

  • An Ultrasound machine (Madison X6) with superficial linear and curved probe.
  • A 19 gauge echogenic needle and Plexolong Cather (PAJUNK, Plexolong Meier nanoline, Geisingen, Germany; 60 mm).
  • A 17-gauge Tuohy needle and 19 G flex-tip catheter: for thoracic epidural.
  • Spirometer: (Enraf-Nonius, Model SPIRO 601).
  • Drugs: isobaric bupivacaine 0.25% (aside from the drugs used in the standard operation theatre).
  • Computer software: computer generated random tables (for randomization) and SPSS 22 (for data analysis)

Thoracic epidural (TEP):

A pre-procedural ultrasound examination will be done to first identify the correct targeted thoracic level. To accomplish this, the transducer will be placed in the parasagittal plane approximately 5 cm from midline. The thoracic level will be determined by identifying the 12th rib and counting in a cephalad direction until the targeted level is marked.

All epidurals will be performed under all aseptic precautions with a 17-gauge Tuohy needle and 19 G flex-tip catheters. Using the loss of resistance to saline technique, catheters will be inserted 4 cm into the epidural space and a suitable test dose will be administered to exclude intravascular or sub-arachnoid injection

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 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •ASA II, III
  • •elective kidney surgery

排除标准

  • •patient refusal
  • •contraindications to neuraxial blocks
  • •pneumonectomy
  • •planed postoperative mechanical ventilatoin

研究组 & 干预措施

thoracic epidural group

Active Comparator

patients in this group will receive ultrasound guided thoracic epidural block preoperatively for pain management, continuous infusion of 0.5% bupivacaine through epidural catheter during operation and early post-operative period

干预措施: thoracic epidural block (Procedure)

paravertebral group

Active Comparator

patients in this group will receive ultrasound guided pararvertebral block preoperatively for pain management, continuous infusion of paravertebral bupivacaine 0.5% through paravetebral catheter during operation and early post-operative period

干预措施: paravertebral block (Procedure)

结局指标

主要结局

vital capacity

时间窗: 24 hours after operation

measured by spirometer (Enraf-Nonius, Model SPIRO 601 medical Technologies)

forced vital capacity

时间窗: 24 hours after operation

measured by spirometer (Enraf-Nonius, Model SPIRO 601 medical Technologies)

forced expiratory volume in one second

时间窗: 24 hours after operation

measured by spirometer (Enraf-Nonius, Model SPIRO 601 medical Tecnologies)

次要结局

  • diaphragmatic excursion(24 hours after operation)
  • pain score(24 hours after operation)

研究者

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

Khaled Abdelbaky Abdelrahman

Assistant professor

Assiut University

研究点 (1)

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