跳至主要内容
临床试验/NCT03701126
NCT03701126Unknown不适用

Ultrasound Guided Transversus Abdominis Plane Block Versus Caudal Block in Inguinal Hernia Repair Surgery in Pediatrics

Zagazig University1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2018年11月1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
入组人数
44
试验地点
1
主要终点
Time for first analgesic request

研究概览

简要总结

The use of pediatric regional anesthesia has increased because of its effective pain control, improved safety profile of local anesthetic agents, in addition to the introduction of ultra-sound. At present, caudal block is one of the most common regional anesthetic techniques employed in pediatric surgery. In addition to providing postoperative analgesia, caudal block significantly reduces intraoperative analgesic requirements and upper airway complications. Transversus abdominis plane (TAP) block involves infiltration of local anesthetics to the plane between the internal oblique and transversus abdominis muscles. Indeed, TAP block offers a hemodynamic stability, appropriate intra-operative analgesia and post surgical analgesia of the abdominal wall.

详细描述

The use of pediatric regional anesthesia has increased because of its effective pain control, improved safety profile of local anesthetic agents, in addition to the introduction of ultra-sound.

At present, caudal block is one of the most common regional anesthetic techniques employed in pediatric surgery. In addition to providing postoperative analgesia, caudal block significantly reduces intraoperative analgesic requirements and upper airway complications.

However, in recent days there is a trend toward the use of peripheral nerve blockade wherever applicable, given the lower incidences of adverse effects when compared with neuron-axial techniques. Furthermore, there may be specific anatomic variations or abnormalities which preclude the use of caudal block.

The abdominal wall consists of three muscular layers, the external oblique abdominis muscle (EOAM), the internal oblique abdominis muscle (IOAM), and the tranversus abdominis muscle (TAM), and their associated fascial sheaths. The central abdominal wall also includes the rectus abdominis muscles and its associated fascial sheath. This muscular wall is innervated by nerve afferents that course through the transversus abdominis neuron-fascial plane.

Transversus abdominis plane (TAP) block involves infiltration of local anesthetics to the plane between the internal oblique and transversus abdominis muscles. Indeed, TAP block offers a hemodynamic stability, appropriate intra-operative analgesia and post surgical analgesia of the abdominal wall.

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
None

入排标准

年龄范围
3 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • ASA (American society of anesthiologists) physical status grade I-II.
  • Operations not extending more than two hours.
  • Unilateral surgeries.

排除标准

  • Refusal of parents.
  • Urgent cases.
  • Bilateral or Complicated hernias (i.e., obstructed, strangulated, irreducible ...).
  • Other contraindication of regional anesthesia e.g. septic focus at site of injection, patients on anticoagulant therapy or suffering from coagulopathy, allergy to local anesthetic drug.
  • Prolonged operations more than two hours.

研究组 & 干预措施

group B

Active Comparator

Caudal block using 1ml/kg of bupivacaine 0.25% under ultrasound guidance

干预措施: Ultra-sound guidance (Device)

group A

Active Comparator

Transversus Abdominis Plane block using 1ml/kg of bupivacaine 0.25% under ultrasound guidance

干预措施: Transversus Abdominis Plane Block (Procedure)

group A

Active Comparator

Transversus Abdominis Plane block using 1ml/kg of bupivacaine 0.25% under ultrasound guidance

干预措施: Bupivacaine 0.25% Injectable Solution (Drug)

group A

Active Comparator

Transversus Abdominis Plane block using 1ml/kg of bupivacaine 0.25% under ultrasound guidance

干预措施: Ultra-sound guidance (Device)

group B

Active Comparator

Caudal block using 1ml/kg of bupivacaine 0.25% under ultrasound guidance

干预措施: Caudal Block (Procedure)

group B

Active Comparator

Caudal block using 1ml/kg of bupivacaine 0.25% under ultrasound guidance

干预措施: Bupivacaine 0.25% Injectable Solution (Drug)

结局指标

主要结局

Time for first analgesic request

时间窗: 24 hours after surgery

by investigator till hospital discharge, then through telephone with parents after discharge

次要结局

  • Total Opioid consumpsion(During operation)
  • Total Ibuprofen consumption(24 hours after surgery)
  • post operative pain score.(2 , 4 , 8 , 12 & 24 hours after surgery.)
  • parents satisfaction score.(24 hours after surgery)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Mohammed Abdullah Seliem Mekawy

Principal investigator

Zagazig University

研究点 (1)

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