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临床试验/NCT03520907
NCT03520907已完成不适用

The Effect of the Transversalis Fascia Plane Block on Postoperative Pain Behavior After Hernia Repair Surgery in Children - Comparison With Conventional Ilioinguinal/Iliohypogastric Nerve Block-

Kazuhiko Okuyama, MD1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2018年4月26日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
walking appearance

研究概览

简要总结

This study compares the transversalis fascia plane block with the ilioinguinal/iliohypogastric nerve block in children undergoing hernia repair surgery.

Half of participants will receive the transversalis fascia plane block, while the other will receive the ilioinguinal/iliohypogastric nerve block.

详细描述

The ilioinguinal/iliohypogastric nerve block (II/IH B)is a widely used regional anesthesia technique in inguinal hernia repair surgery. However, this block provides limited analgesia during and after surgery, and the patients feel pain when walking. The transversalis fascia plane block (TFPB) is a recently developed technique and several case reports presented its efficacy for inguinal repair surgery in adult patients. It may block not only ilioinguinal and iliohypogastric nerves but also splanchnic nerves, which is conveyed via the thoracolumbar fascia. Therefore, we compare the effect of the TFPB and II/IH B on postoperative pain and walking form.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
2 Years 至 13 Years(Child)
性别
All
接受健康志愿者

入选标准

  • the patients undergoing unilateral open hernia repair surgery

排除标准

  • known allergy to local anesthetics, psychomotor retardation, anti-epileptic drugs usage, anti-inflammatory drug usage

研究组 & 干预措施

Transversalis Fascia Plane Block

Experimental

receive transversalis fascia plane block with 0.4 ml/kg of 0.25% levobupivacaine after establishment of general anesthesia.

干预措施: Transversalis Fascia Plane Block (Drug)

Ilioinguinal/iliohypogastric Nerve Block

Active Comparator

receive ilioinguinal/iliohypogastric nerve block with 0.1 ml/kg of 0.25% levobupivacaine after establishment of general anesthesia.

干预措施: Ilioinguinal/iliohypogastric Nerve Block (Drug)

结局指标

主要结局

walking appearance

时间窗: 3 to 5 hours after surgery

scoring a way of walking; 0: brisk walk, big step, able to skip (= no pain) to 5: not able to stand up ( = worst pain)

次要结局

  • FLACC (face, legs, activity, cry, consolability) score(3 to 5 hours after surgery)
  • Faces Pain Scale revised(3 to 5 hours after surgery)
  • additional pain curer usage(up to 5 hours after surgery)

研究者

发起方
Kazuhiko Okuyama, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Kazuhiko Okuyama, MD

Chief Anesthesiologist

Ibaraki Children's Hospital

研究点 (1)

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