跳至主要内容
临床试验/NCT04945512
NCT04945512Unknown不适用

Efficacy of Epidural Analgesia Initiated in the Preoperative Period in Lower Extremity Osteosarcoma

Istanbul University2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2021年11月7日最近更新:
适应症

试验速览

阶段
不适用
入组人数
28
试验地点
2
主要终点
Opioid consumption

研究概览

简要总结

In this study, the investigators aim to reduce complications in orthopedic malignancy surgeries and to increase the quality of life of patients who will be operated on.

详细描述

In the preoperative period, the participants will be taken to the block room. The participants will be monitored, standard sedation will be applied.

Patients in the first group will be provided with preoperative and peroperative analgesia with an epidural catheter. The second group patient will be get no block. Afterwards, both groups will be operated under similar general anesthesia conditions. A patient-controlled analgesia device will be attached to each group of participants and their postoperative follow-up will be made.

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
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • accepting the study protocol,
  • age older than 18 years and younger than 80 years,
  • undergoing lower extremity osteosarcoma surgery
  • the American Society of Anesthesiologist (ASA) physical status of I-II-III

排除标准

  • infection at the injection site
  • coagulation disorder
  • patients with central nervous system related disease
  • septic patients

结局指标

主要结局

Opioid consumption

时间窗: 48 hours

miligram

Measurement of postoperative pain

时间窗: 48 hours

VAS (visual analog scale) (0: no pain, 10: the worst pain imaginable)

次要结局

  • Beck Depression Inventory (BDI)(Will be done 2 times 1- on pre-operative hospitalization 2- in the 1st month follow-up after surgery])
  • Amount of peroperative bleeding(During surgery)
  • Amount of postoperative bleeding(48 Hours)
  • Patient satisfaction(Will be done 3 times 1- a day after surgery 2- in the 1st week follow up after surgery 3- in the 1st month follow-up after surgery)
  • Postoperative complications(postoperative period up to 3 days)
  • Intensive care unit stay(48 hours)
  • Hospital stay(72 hours)

研究者

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

Nur Canbolat

Principle Invastigator, M.D.

Istanbul University

研究点 (2)

Loading locations...

相似试验