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临床试验/NCT06987240
NCT06987240已完成不适用

Comparison Of Ultrasound-Assisted Combined Spinal Epidural Procedure With Anatomical Landmark Method In Obese Patients Undergoing Lower Extremity Surgery

Sakarya University2 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2025年5月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
68
试验地点
2
主要终点
First attempt success rate

研究概览

简要总结

A comparison of two different methods used in routine anesthesia practices will be made for the insertion of a catheter that will be placed at the waist for anesthesia in obese patients who will undergo orthopedic surgery.

60 obese patients aged 40-80, ASA II-III, BMI>30, who are planned to undergo elective orthopedic lower extremity surgery by placing a combined spinal epidural catheter at Sakarya University Medical Faculty Education and Research Hospital will be included in the study.

General anesthesia or regional anesthesia techniques are routinely used in lower extremity surgery in our clinic. When placing a combined spinal epidural catheter, the entry site is determined by looking at anatomical landmarks or using ultrasound.

Patients will be divided into two different groups as Anatomical Marking or Ultrasound.

Patients in the Ultrasound group will be taken to the block room in our operating room before the operation and a location marking will be performed with Ultrasound in the block room.

Patients in the Anatomical Marking group will be brought to a sitting position in the operating room in the operating room and a location marking will be performed by hand examination.

After determining the needle entry site, patients in both groups will undergo the Combined spinal epidural catheter placement procedure, which is performed routinely under sterile conditions, and the success rate at the first attempt, total success rates, number of needle redirections, and complications during the procedure will be compared.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

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

入选标准

  • ASA II-III
  • Elective orthopedic lower extremity surgery
  • Combined spinal epidural anesthesia (CSEA)

排除标准

  • Patients with CSEA contraindication
  • Diagnosed with scoliosis
  • Patients with anatomical disorders
  • Patients who did not agree to participate in the study
  • Patients for whom follow-up conditions could not be met

结局指标

主要结局

First attempt success rate

时间窗: up to 20 weeks

FIRST TRY SUCCESS; will be defined as FINDING THE EPIDURAL SPACING WITHOUT REMOVING THE NEEDLE FROM THE SKIN.

次要结局

  • Time to determine the needle insert(up to 20 weeks)
  • Number of needle insertions(up to 20 weeks)
  • Total procedure time(up to 20 weeks)

研究者

发起方
Sakarya University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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