Comparison of Ilioinguinal / Iliohypogastric Block and Caudal Block for Postoperative Analgesia in 3-7 years old Children Undergoing herniorrhaphy surgery

Comparison of Ilioinguinal / Iliohypogastric Block and Caudal Block for Postoperative Analgesia in 3-7 years old Children Undergoing herniorrhaphy surgery

Clinical trial, parallel groups, double-blind, randomized, phase 3 on 72 patients. In order to randomize, the block randomization method will be used.

In this research, all children aged 3-7 years with inguinal hernia referred to Hazrat Ali Asghar Hospital in Tehran will be included in the study. Patients based on blocks 8 will be randomly divided into 2 groups. The sample size for each study group will 30 people. Parents of the children (patients), surgeon and data analyst will be blinded. The surgeon and the children's parents will be aware that they will be randomly assigned to one of two treatment groups, but they will not know which treatment will be given in which group. The person in charge of data collection, the analyst and the outcome evaluator will collect and analyze the information based on groups 1 and 2 and will not know the type of treatment provided in the groups.

Inclusion criteria: Children aged 3-7 years, Suffering from Inguinal hernia, A person with normal health, A person with mild systemic disease, Normal CBC/PT/PTT/INR tests. Exclusion criteria: Sensitivity to the drugs used in this study, Seizure history, Injection site infection, Spine problems, Congenital neurological diseases, Neurological disorders and any type of neuropathy, Body mass index greater than 30, Coagulation disorders.

Intervention group 1 includes children with inguinal hernia who receive the caudal block intervention of the child in the lateral decubitus position. Intervention group 2 includes children with inguinal hernia who receive ilioinguinal and iliohypogastric block intervention in supine position.

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Patients will be randomly divided into 2 groups. Block randomization method will be used for randomization. The randomization tool will be a table of random numbers. For this purpose, 8 blocks will be formed and in each block 4 people from the intervention group and 4 people will be placed in the control group. A total of 9 blocks will be considered to reach the sample size. In order to hide the random allocation, opaque envelopes sealed with a random sequence will be used. In this method, each of the generated random sequences will be recorded on a card and the cards respectively will be placed in the envelopes. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box. At the time of registration of participants, based on the order of entry of qualified participants into the study, one of the envelopes will be opened in order and the assigned group of that participant will be revealed.

Patients will be blinded to the type of block. The surgeon parents of the children (patients) will be unaware and blinded of the type of block. Children's parents will be aware that they will be randomly assigned to one of the two treatment groups, but will not know which block will be provided in that group. Patients will be assigned to one of two groups using a random number table. The person in charge of data collection, the analyst and the outcome evaluator will collect and analyze the data based on groups 1 and 2 and will not know the type of treatment provided in the groups and will be kept blind.