跳至主要内容
临床试验/NCT05278598
NCT05278598已完成不适用

Comparative Assessment of 3 Ultrasound Guided Plane Blocks for Perioperative Analgesia in Patients Undergoing Radical Cystectomy: A Randomized Clinical Trial

Nazmy Edward Seif1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年3月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
Morphine consumption.

研究概览

简要总结

Radical cystectomy is the gold standard treatment for muscle invasive bladder cancer as well as some T1 and non-invasive disease. It is a major operation with significant perioperative morbidity and complications. Pain is one of the most important complications to be managed.

Regional blocks as a part of multi-modal analgesia are considered main strategies of Enhanced Recovery after Surgery (ERAS) decreasing post-operative complications including post-operative pain and post-operative hospital stay. They also have an upper hand over systemic intravenous opioids decreasing the risk for post-operative delirium specially in old age patients. Thoracic paravertebral plane block (TPVPB), intra muscular quadratus lumborum plane block (QLPB) and erector spinae plane block (ESPB) are among these regional anesthesia techniques for pain management.

Erector spinae plane block is an emerging block, with low risk and more feasibility, but efficacy hasn't been compared to quadratus lumborum and paravertebral plane blocks altogether in radical cystectomy surgeries.

All these blocks are effective in reducing postoperative pain and the need of analgesia in radical cystectomy surgery; this is a comparative study between the three blocks in this population.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologists (ASA) class II - III.
  • Adult patients scheduled for radical cystectomy.

排除标准

  • Patient refusal.
  • Uncooperative patients.
  • Patients with known allergies to local anesthetics.
  • Bleeding disorders or coagulopathy.
  • Anatomical abnormality or infection at injection site.
  • Patients receiving opioids for chronic analgesic therapy.
  • Spinal anesthesia or any other regional anesthesia.

结局指标

主要结局

Morphine consumption.

时间窗: 24 hours

Total dose of Morphine (measured in mg) given intra-venously to the patient post-operatively.

次要结局

未报告次要终点

研究者

发起方
Nazmy Edward Seif
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Nazmy Edward Seif

Clinical Professor

Cairo University

研究点 (1)

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