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临床试验/NCT02807194
NCT02807194已完成不适用

Epidural Anesthesia Versus General Anesthesia for Elective Lumbar Disk Surgery in a Outpatient Basis

CHU de Reims2 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2014年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
CHU de Reims
入组人数
51
试验地点
2
主要终点
consumption of analgesic Level III (according to WHO criteria)

研究概览

简要总结

Primary Goal: To compare the clinical outcomes of spinal anesthesia and general anesthesia in surgery for lumbar disc herniation.

详细描述

Patients included: All patients in the neurosurgery department of the University Hospital of Reims or in the neurosurgery department of CHG Chalons en Champagne for surgical management of lumbar disc herniation and agreeing to participate in the research. The types of anesthesia (general anesthesia or spinal anesthesia) will be randomized.

Investigation Plan: Participation in the research will be available to any eligible patient during the anesthesia consultation prior hospitalization for surgery. If the patient agrees to participate in research, randomization of the anesthetic technique will be realized. The anesthetist and the patient will be informed of the outcome of this randomization. Hospitalization of patients will not be changed. They will be hospitalized in inpatient, as usual, with an entry the day before surgery and an outlet the next day (without complications). The surgery itself will not be changed. The patient's postoperative monitoring will not be changed. Data will be collected for each patient: demographic data, medical data, data about the intervention and anesthesia, postoperative data management.

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
None

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

  • single lumbar disk herniation elective for surgery

排除标准

  • Patients with haemostatic disorder
  • Patients with lumbar spine surgery history
  • Patients with sciatica called "hyperalgesia" resistant to treatment including systemic corticosteroids and 3 WHO bearing analgesics (oral morphine)
  • Patients with true paralyzing sciatica with motor disorders compatible with the path of the root compressed by the herniation
  • Patients with sphincter disorders
  • Patients with herniated disc multistage
  • Pregnant women
  • Patients with comorbid against-showing the elongated position, including cardiorespiratory comorbidities
  • Minors patients
  • Patients protected by law.

结局指标

主要结局

consumption of analgesic Level III (according to WHO criteria)

时间窗: 24hours

次要结局

未报告次要终点

研究者

发起方
CHU de Reims
申办方类型
Other
责任方
Sponsor

研究点 (2)

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