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临床试验/NCT06701162
NCT06701162已完成不适用

TRANSVERSE ABDOMINAL PLANE BLOCK VS. ILIO-INGUINAL ILIO-HYPOGASTRIC BLOCK in PEDIATRIC INGUINAL SURGERY

Tunis University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Quality of postoperative analgesia : PPMP score

研究概览

简要总结

The ilio-inguinal ilio-hypogastric (IIIH) nerve block remains the gold standard analgesic technique after inguinal surgery in children. Transverse abdominal plane (TAP) block has been reported to provide effective analgesia after lower abdominal surgery in adults. The aim of our study was to compare the analgesic effect of ultrasound-guided TAP block to IIIH nerve block after inguinal surgery in children.

详细描述

The study aimed to compare the analgesic effect of ultrasound-guided transverse abdominal plane (TAP) block to ilio-inguinal ilio-hypogastric (IIIH) nerve block in children after inguinal surgery. This prospective, randomized study included children aged six months to twelve years, classified as ASA I or II, scheduled for elective unilateral inguinal surgery. Participants received either a TAP block or an IIIH block with bupivacaine following standardized induction of general anesthesia. Analgesics were not systematically administered post-induction. Postoperative pain was monitored for six hours in the hospital, and if the CHEOPS score exceeded 7, paracetamol was administered, with nalbuphine as a secondary option if needed. At home, parents assessed pain using the PPMP score, administering paracetamol and ibuprofen if necessary. Primary outcomes included postoperative analgesia quality, determined by time to first analgesic requirement and the need for analgesics at hospital and home. Secondary outcomes measured included block performance duration, parental satisfaction, and incidence of complications.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
6 Months 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged 6 months to 12 years
  • ASA physical status 1 or 2
  • Scheduled for unilateral inguinal surgery

排除标准

  • Children scheduled for bilateral surgery or associated procedures (e.g., circumcision)
  • Parental refusal

结局指标

主要结局

Quality of postoperative analgesia : PPMP score

时间窗: 24 h after surgery

The quality of postoperative analgesia described by the pain score : Postoperative Pain Measure for Parents (PPMP) score, minimum value is 0 , maximum value 10 , a value higher than 6 indicates a major pain .

次要结局

  • Block execution time(From the beginning of the practice of the block to the end)
  • Complications related to the techniques of nerve block(Perioperative)

研究者

发起方
Tunis University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mehdi Trifa

Head of the Department of Anesthesiology and Critical Care

Tunis University

研究点 (2)

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