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临床试验/NCT04590027
NCT04590027已完成不适用

Caudal Block Versus Local Wound Infiltration for Inguinal Procedures in Young Children. A Prospective Observational Trial

University Hospital Tuebingen0 个研究点目标入组 86 人开始时间: 2014年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
86
主要终点
Comparison of Analgesia Quality Between the Two Groups

研究概览

简要总结

Single-centre observational study to analyse whether there is a difference in post-operative pain scores and set up time when comparing caudal block with local wound infiltration

详细描述

Inguinal procedures in children are surgical frequently performed in an outpatient setting. This study analyzed regional analgesia for inguinal procedures in toddlers comparing caudal block with local wound infiltration and assessed post-operative pain scores as well as process times.A number of documents were compiled to inform and record data: a standard anaesthesia protocol, a documentation sheet for intraoperative recording, an information leaflet for the parents and a documentation sheet for the post-operative course of 24 hours .

Caudal anaesthesia was performed after induction of anaesthesia. In patients getting wound infiltration ropivacaine 0.375% 0.5 ml kg-1 was injected subcutaneously after closing of the fascia transversalis.

Parents were informed about the study and invited to participate upon arriving on the outpatient ward if the patient fulfilled the following inclusion criteria: scheduled for elective inguinal procedure, age three to 72 months, no contraindication for either local or caudal analgesia, no comorbidities. If parents agreed to participate, written informed consent was obtained. Pain score and administration of analgesics, vomiting, interval until micturition and interval until mobilization as well as sleep quality during the first post-operative night were documented by the parents in the provided booklet.

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
3 Months 至 68 Months(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • no return of questionnaire
  • parents do not understand language

结局指标

主要结局

Comparison of Analgesia Quality Between the Two Groups

时间窗: Arrival on postoperative care unit (PCU), arrival ward, 1h, 2 h 3h, 4h, 5h, 6h, 12h. 24h,

Visual Analog Score (VAS) Minimum 0 (no pain) and Maximum 10 (worst pain) A two point difference of mean pain scores was defined as clinically meaningful to establish a superiority for one of the procedures of pain management

次要结局

  • Set up Time(Time in minutes measured between start of induction of anesthesia to start of surgical incision)
  • Rescue Medication(24 hours)
  • Neurological Outcome(24 hours)

研究者

申办方类型
Other
责任方
Sponsor

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