Pharmacoepidemiology Study on Real Life Impact of Chloroprocaine (CLOROTEKAL®) on the Eligibility for Discharge From Hospital of Patients Requiring Short Outpatient Surgery Under Spinal Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 620
- 试验地点
- 1
- 主要终点
- Impact of CLOROTEKAL® on the discharge from hospital
研究概览
简要总结
The purpose of this study is to assess, in real life, the efficacy and the eligibility for discharge of a local anesthetic, CLOROTEKAL®, used for spinal anesthesia in short outpatient surgery.
详细描述
This is a longitudinal, observational, prospective, multicentre, national study, conducted in France, from a representative sample of physician anesthetists.
The efficacy and safety in real life of CLOROTEKAL® will be assessed in patients undergoing a short outpatient surgery under spinal anesthesia. Data will be collected by the physician during two visits (pre-anesthesia and per-postoperative consultation). Additional data regarding the patient's perception (safety, pain and satisfaction) will be collected using a self-questionnaire.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients seen in pre-anesthesia consultation for ambulatory surgery
- •Patients for whom a spinal anesthesia using CLOROTEKAL® is planned
- •Patients accepting and able to complete a satisfaction self-administered questionnaire
- •Informed patients who accept the computer processing of their medical data and their right of access and correction
排除标准
- •Patients with contra-indications to spinal anesthesia (eg decompensated cardiac insufficiency, hypovolemic shock....)
- •Patients with contra-indications to chloroprocaine (hypersensitivity to the active substance, medicinal products of the para-aminobenzoic acid ester group, other ester-type local anaesthetics or to any of the excipients ; Intravenous regional anaesthesia (the anesthetic agent is introduced into the limb and allowed to set in while tourniquets retain the agent within the desired area), serious problems with cardiac conduction, severe anemia)
- •Patients participating or having participated in the previous month in a clinical trial in anesthesiology
结局指标
主要结局
Impact of CLOROTEKAL® on the discharge from hospital
时间窗: Average time expected around 180 min after the surgery (Lacasse, 2011)
Time to eligibility for discharge from hospital measured as the time between the intrathecal injection and achieving the criteria of Lacasse. This period will be described globally (average time) and by groups: \<180 min ; \<240 min ; \<300 min ; \<360 min ; \> 360 min.
次要结局
- Modalities of spinal anesthesia with CLOROTEKAL®(During surgery)
- Safety of CLOROTEKAL(Up to 24 hours after surgery)
- Patients' satisfaction(24h after surgery)
- Postoperative patients pain(During the 24 hours following surgery)
- Rate of unplanned admissions related to anesthesia and/or surgery(Within the same day than surgery)