跳至主要内容
临床试验/NCT03388671
NCT03388671Unknown2 期

Laparoscopic Guided Transversus Abdominis Plane Block for Postoperative Analgesia After Pediatric Laparoscopic Surgery.

Assiut University1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2017年12月25日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
44
试验地点
1
主要终点
FLACC PAIN score

研究概览

简要总结

The aim of this study will be to investigate the safety and analgesic efficacy of Transversus Abdominis Plane (TAB) Block versus psoas block blockade. Both blocks will be administered surgically and guided by the laparoscopy screen in children undergoing laparoscopic surgery.

详细描述

Transversus abdominis plane (TAP) block is a promising effective method for postoperative pain control after major abdominal surgery. TAP block provides analgesia by inhibiting nerve conduction from the anterior abdominal wall arising from the intercostal nerves, subcostal nerves, and first lumbar nerve (T6-L1). Using a landmark technique, it is easily performed, but its popularity has decreased because of reduced efficacy due to inaccurate injection and the potential for intra-peritoneal organ damage. Ultrasound-guided TAP block provides better results and fewer complications, but it requires experienced operators. Surgically administered TAP (sTAP) block guided by the video camera of the laparoscope is a simple technique and may cause no complications. Also, under laparoscopic guidance, block of ilioinguinal, iliohypogastric, and genitofemoral nerves can be possible with anesthetic injection in the plane between psoas major and the fasciae covering its anterior aspects [laparoscopic-assisted psoas (LAP) blockade].

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
Double (Participant, Outcomes Assessor)

盲法说明

The data collection personnel and the patients' guardians will be blinded to the group assignment.

入排标准

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

入选标准

  • Children (1-6 years) of both sexes undergoing elective laparoscopic surgeries that last >30minutes (eg. undescended testis and inguinal hernia repair).
  • Written consent, free and informed

排除标准

  • Significant respiratory, cardiac or renal disease
  • BMI >95th percentile for age.

研究组 & 干预措施

TAB Block

Active Comparator

Patients will recieve 0.3ml/kg bupivacaine 0.25% on each side for laparoscopically guided Transversus abdominis plane block.

干预措施: TAB Block (Procedure)

TAB Block

Active Comparator

Patients will recieve 0.3ml/kg bupivacaine 0.25% on each side for laparoscopically guided Transversus abdominis plane block.

干预措施: Bupivacaine (Drug)

Psoas Block

Active Comparator

Patients will recieve 0.3ml/kg bupivacaine 0.25% on each side for laparoscopically guided psoas block.

干预措施: Psoas Block (Procedure)

Psoas Block

Active Comparator

Patients will recieve 0.3ml/kg bupivacaine 0.25% on each side for laparoscopically guided psoas block.

干预措施: Bupivacaine (Drug)

结局指标

主要结局

FLACC PAIN score

时间窗: 36hours

postoperative FLACC pain scores.

次要结局

未报告次要终点

研究者

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

Hala Saad Abdel-Ghaffar

principal investigator

Assiut University

研究点 (1)

Loading locations...

相似试验