跳至主要内容
临床试验/CTRI/2021/01/030775
CTRI/2021/01/030775尚未招募不适用

Comparative study to evaluate analgesic efficacy between USG -guided transverse fascia plane block and conventional ilioinguinal/ iliohypogastric nerve block for inguinal surgeries -Prospective randomized trial

Super Speciality Paediatric Hospital and Post Graduate Teaching Institute1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年1月27日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
The primary outcome of the study is to compare the duration of postoperative analgesia (time to first analgesic request)

研究概览

简要总结

Pain is perhaps the most petrified symptoms of surgery, especially in the  paediatric age groups which is being tried to alleviate and conquer since ages. Fear of needles and mask, emotional liability and a limited reserve of vital function are the confounding factor, contributing further to the difficulties in dealing with this vulnerable age group. The ability to express distress and discomfort is limited in young children due to difficulty in communication,thus pain is usually underestimated and treated, causing impairment in pulmonary, cardiovascular, gastrointestinal, Neuro-endocrine and metabolic function.

Inguinal surgeries are among the most common day care procedure in children.Various modalities have been used to cure postoperative pain.Peripheral nerve blocks with local anesthetics are commonly employed method in subumblical surgeries.Iliogastric and Ilioinguinal nerve blocks (IINB) are used,combined with general anaesthesia for intraoperative supplementation and also as a sole entity for postoperative pain.The IINB has been found to decrease the requirement of analgesics for up to 48hrs after inguinal surgeries.Nowadays USG guided peripheral block are commonly used for effective amelioration of the same and has been regarded as a gold standard for nerve localization in clinical anaesthesia. USG Transeverse fascia plane block (TFP) is the preferred method to reduce the use of opioids and systemic analgesics for postoperative pain management.TFP block provide anaesthesia and analgesia in the inguinal region by blocking the ilioinguinal and iliohypogastric nerves.The ilioinguinal/Iliohypogastric (II/IHB) is a widely used regional anaesthesia technique in inguinal hernia repair surgery.However,this block provides limited analgesia during and after surgery,and the patients feel pain when walking.The transverse fascia plane block is a recently developed technique and several case reports presented its efficacy for inguinal repair surgeries in adult patients.It may block not only ilioinguinal and iliohypogastric nerves but also splanchnic nerves,which is conveyed via thoracolumber fascia and  mayprovide better and prolong analgesia.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
12.00 Month(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • 1 Scheduled for inguinal surgeries (inguinal surgery) 2 Age 12 months to 12 years
  • ASA physical status I or II.

排除标准

  • 1 Known contraindication to a peripheral nerve block such as severe coagulopathy 2 Allergy to amide local anesthetics 3 Local infection at the planned injection 4 Refusal by parents/guardians.

结局指标

主要结局

The primary outcome of the study is to compare the duration of postoperative analgesia (time to first analgesic request)

时间窗: The primary outcome of the study is to compare the duration of postoperative analgesia (time to first analgesic request)

次要结局

  • 1.Intraoperative and postoperative hemodynamic stability(2.Intraoperative fentanyl consumption)

研究者

发起方
Super Speciality Paediatric Hospital and Post Graduate Teaching Institute
申办方类型
Research institution and hospital

研究点 (1)

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