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临床试验/CTRI/2025/04/085561
CTRI/2025/04/085561尚未招募不适用

Comparative evaluation of postoperative analgesia between ultrasound guided lumbar erector spinae plane block and ilioinguinal-iliohypogastric block in children undergoing inguinal hernia surgeries: A Randomised Controlled trial

Chacha Nehru Bal Chikitsalaya1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2025年2月5日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
58
试验地点
1
主要终点
Time to requirement of first rescue analgesia in the postoperative period

研究概览

简要总结

Inguinal hernia surgery is a daycare procedure. Paediatric patients who are undergoing inguinal hernia surgeries experience pain intraoperatively and postoperatively which persists as a chronic pain. Caudal analgesia was the preferred regional technique till date. However this technique has its own limitations like short duration of action and complications because of the drug administration in the epidural space. To overcome these we are comparing ultrasound guided Erector spinae plane block and ilioinguinal-iliohypogastric nerve block which are plane blocks. They are simple effective and with less complications. The postoperative anlagesia will be evaluated using Wong bakers faces pain rating scale and postoperative sedation will be evaluated using Ramsay sedation score. ASA I and II patients of age 3 to 8 years are included in the study who are undergoing inguinal hernia surgery on an elective basis. The primary outcome will be to evaluate the time to first rescue analgesia between two groups in the postoperative period. The secondary outcome is to compare the incidence of the complications like apnea, desaturation and hypotension.

The study will be conducted for a period of 1 year.

Sample size was calculated by assuming mean difference in time to first rescue analgesia between ilioinguinal iliohypogastric nerve block group and Erector spinae plane block group as 250 mins as per El.Emam Em et al. The required sample size will be 26 per group approximately. Considering drop out ratio of 10% 3 patients added to each group making approximately 29 in each group.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
3.00 Year(s) 至 8.00 Year(s)(—)
性别
All

入选标准

  • Age 3 to 8 years ASA physical status I and II Posted for elective inguinal hernia surgeries under general anaesthesia.

排除标准

  • •History of developmental delay/ mental retardation •Patients undergoing laparoscopic herniotomy/ bilateral open herniotomy •Anomalies of spine and central nervous system •History of allergy to drugs used in study.
  • •History of bleeding disorders •Infection at injection site •Parent refusal to the procedure.

结局指标

主要结局

Time to requirement of first rescue analgesia in the postoperative period

时间窗: From the time of administration of the nerve block till the requirement of postoperative analgesia

次要结局

  • To compare the incidence of complications like hypotension, bradycardia, nausea and vomiting, apnea, desaturation(Postoperative sedation scores)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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