Postoperative Pain in Children After Low-Pressure Versus Medium-Pressure Pneumoperitoneum in Laparoscopic Surgery
概览
- 阶段
- 不适用
- 干预措施
- Laparoscopic appendectomy
- 疾病 / 适应症
- Appendicitis Acute
- 发起方
- University Children's Hospital, Zurich
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Postoperative pain score on postoperative day one (abdominal pain)
- 状态
- 已完成
- 最后更新
- 2个月前
概览
简要总结
The purpose of this study is to asses whether the pressure used for the pneumoperitoneum during laparoscopic surgery in children affects their postoperative pain levels.
研究者
入排标准
入选标准
- •Prepped and consented for diagnostic laparoscopy for likely acute appendicitis
- •5 years or older
- •15 kg or more
- •Parents/legal custodian give consent, patient shows no signs of unwillingness to participate
- •Patient is hemodynamically stable
排除标准
- •Clinical signs of four quadrant peritonitis as a clinical sign of perforated appendicitis
- •Suspected perityphlitic abscess on preoperative ultrasound
- •Preexisting conditions making postoperative assessment of extent of pain and its localization very difficult or impossible, e.g. conditions that are associated with pronounced developmental delays or with communication difficulties
- •Parents have inadequate knowledge of German language to understand Informed consent
- •Child has inadequate knowledge of German language to allow elicitation of Pain Scores
研究组 & 干预措施
Low pressure pneumoperitoneum
Use of low pressure pneumoperitoneum during laparoscopic appendectomy
干预措施: Laparoscopic appendectomy
Medium pressure pneumoperitoneum
Use of medium pressure pneumoperitoneum during laparoscopic appendectomy
干预措施: Laparoscopic appendectomy
结局指标
主要结局
Postoperative pain score on postoperative day one (abdominal pain)
时间窗: Postoperative day one.
Postoperative pain score for abdominal pain on postoperative day one after laparoscopic appendectomy using the Faces Pain Score Revised (FPS-R score), a self-reported pain score using drawn faces with values from 0 (no pain) to 10 (most pain). It is validated for use in studies with children.
次要结局
- Analgesic use(Through study completion, an average of 3 days)
- Length of operation(Intraoperative)
- Length of stay(Through study completion, an average of 3 days)
- Postoperative pain scores during postoperative phase (abdominal pain)(Through study completion, an average of 3 days)
- Postoperative pain scores during postoperative phase (shoulder pain)(Through study completion, an average of 3 days)
- Intra- and postoperative complications(Through study completion, an average of 3 days)