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临床试验/NCT02580500
NCT02580500Unknown不适用

Epidural and Spinal Anesthesia Techniques in Pilonidal Dermoid Sinus Surgeries: Prospective Randomized Trials

Lütfiye Nuri Burat Government Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
sensory block duration(time:hour)

研究概览

简要总结

Pilonidal dermoid cyst surgery under general anesthesia and regional anesthesia techniques is used.regional anesthesia techniques; spinal, epidural, spinal epidural (combined) and is the local anesthesia.In the investigators study, pilonidal dermoid cyst surgery in spinal and epidural anesthesia techniques activity, reliability will be compared to the side effects and complications.

One hundred patients will be randomly assigned to either the pilonidal dermoid cyst under Spinal anaesthesia (50 patients)(Group 1) or pilonidal dermoid cyst under epidural anaesthesia (50 patients)(Group 2). Group 1 will be used in spinal catheter in spinal anesthesia procedures or Group 2 will be used epidural catheter in epidural anaesthesia procedures.All patients has symptomatic pilonidal dermoid cyst.

详细描述

Pilonidal dermoid is a tubular skin defect which can be seen in both female and male patients between the ages of 12 to 80. Treatment alternatives includes surgical excision. During the surgical treatment local, general, spinal or epidural anesthesia could be applied. However, local anesthesia usually is not preferred due to the fact that pilonidal dermoid sinuses depth, width could not be determined precisely. General anesthesia also is not preferred due to the fact that difficulties arising from patient's positioning and positioning based potential lung related problems. In general, spinal anesthesia and epidural anesthesia is preferred for pilonidal dermoid sinus surgeries. In this study, the investigators will demonstrate advantages, disadvantages, complications, (sensory and motor block levels), and durations of spinal and epidural anesthesia and superiority of each on these subjects.

Patients who are over 18 and have a America Society of Anesthesiologist (ASA) physical score of I and II will be included in the study. Patients who are pregnant, have a known allergic reactions to local anesthetic and have contraindications against spinal and epidural anesthetic will be excluded from the study.

In this study the investigators separate the patients into 2 groups. Group1: pilonidal dermoid cyst under Spinal anaesthesia (50 patients).Group 1 will be used in spinal catheter in spinal anesthesia procedures ; Group2:pilonidal dermoid cyst under epidural anaesthesia (50 patient).Group 2 will be used epidural catheter in epidural anaesthesia procedures. All patients has symptomatic pilonidal dermoid cyst

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •America Society of Anesthesiologist (ASA) physical score of I and II
  • •the men and women over the age of 18, pilonidal sinus disease

排除标准

  • •Pediatric patients
  • •Pregnant women
  • •Patients with bleeding disorder
  • •Patients with spinal deformity

研究组 & 干预措施

group 2

Active Comparator

Pilonidal dermoid cyst surgery in Epidural anaesthesia

干预措施: epidural catheter (Procedure)

group 1

Active Comparator

Pilonidal dermoid cyst surgery in Spinal anaesthesia

干预措施: spinal catheter (Procedure)

结局指标

主要结局

sensory block duration(time:hour)

时间窗: up to 6 hours

group1 and group 2

次要结局

  • Headache(from end of the operation to postoperative 3 days)
  • Urinary Retention(from end of the operation to postoperative 1 day)
  • Duration of operation(time:hour)(up to 2 hours)
  • Nausea/Vomiting(from end of the operation to postoperative 1 day)

研究者

发起方
Lütfiye Nuri Burat Government Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

TURGUT DONMEZ

General Surgeon, MD

Lütfiye Nuri Burat Government Hospital

研究点 (1)

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