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IRCT20230518058225N3 IRCT 2024-06-02 Iran University of Medical Sciences Comparison of Ilioinguinal / Iliohypogastric Block and Caudal Block for Postoperative Analgesia Undergoing herniorrhaphy surgery Comparison of Ilioinguinal / Iliohypogastric Block and Caudal Block for Postoperative Analgesia in 3-7 years old Children Undergoing herniorrhaphy surgery 2023-08-23 anticipated 72 Complete https://irct.ir/trial/76170 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 hernia. Intervention 1: Intervention group 1: To perform the caudal block, the child will be placed in the lateral decubitus position. We will gather his legs in the abdomen and after prep and drape in sterile conditions, we will find the sacral hiatus and under ultrasound guidance, we will insert the needle and the injection will be done. The anesthetic agent will be ropivacaine 0.02% (manufacturer: Varian Pharmed) and its dosage will be 1 cc per kilogram of the patient's body weight. Intervention 2: Intervention group 2: In ilioinguinal and Iliohypogastric block, at the first, the patient will be in the supine position and after the prep and drape, the line connecting from the ASIS to the navel is divided into 4 equal parts, where the injection site will be ¼ external. Under ultrasound guidance, the local anesthetic ropivacaine 0.02% (manufacturer: Varian Pharmed) will be used at a rate of 1 cc per kilogram of the patient's body weight. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is After completing the work and consulting with all the writers and executive agents, I will make a decision.
public Sepide Bayat
Rasoul-Akram Hospital, Niayesh St., Sattarkahn Ave
Tehran Iran (Islamic Republic of) 1445613131 +98 21 2243 2068 bayat.sepide@yahoo.com Iran University of Medical Sciences scientific Salome Sehat Kashani
Rasoul-Akram Hospital, Niayesh St., Sattarkahn Ave
Tehran Iran (Islamic Republic of) 1445613131 0098 21 64351 sehat.s@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) 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 3 years 7 years Both 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 K40 Inguinal hernia Treatment - Other Treatment - Other Intervention group 1: To perform the caudal block, the child will be placed in the lateral decubitus position. We will gather his legs in the abdomen and after prep and drape in sterile conditions, we will find the sacral hiatus and under ultrasound guidance, we will insert the needle and the injection will be done. The anesthetic agent will be ropivacaine 0.02% (manufacturer: Varian Pharmed) and its dosage will be 1 cc per kilogram of the patient's body weight. Intervention group 2: In ilioinguinal and Iliohypogastric block, at the first, the patient will be in the supine position and after the prep and drape, the line connecting from the ASIS to the navel is divided into 4 equal parts, where the injection site will be ¼ external. Under ultrasound guidance, the local anesthetic ropivacaine 0.02% (manufacturer: Varian Pharmed) will be used at a rate of 1 cc per kilogram of the patient's body weight. Pain. Timepoint: Immediately after surgery and 1, 3, 6, 12, and 24 hours after surgery. Method of measurement: The amount of pain immediately after surgery and 1, 3, and 6 hours after surgery is checked by the FLACC pain scale by the doctor, and at 12 and 24 hours by the Wonk Baker questionnaire from the patient's parents. Iran University of Medical Sciences Approved 2023-01-14 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Hemmat Highway Tehran Tehran Iran (Islamic Republic of)