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IRCT20230315057725N1 IRCT 2023-09-05 Mashhad University of Medical Sciences Evaluation of the efficacy of transverse abdominis plane (TAP) block for pain in pediatrics undergoing appendectomy Evaluation of the efficacy of ropivacaine in transverse abdominis plane (TAP) block for pain in pediatrics undergoing appendectomy : a controlled randomized trial 2023-08-23 anticipated 50 Complete https://irct.ir/trial/71870 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization method is used. Candidates in this study were randomly divided into 2 groups in the form of blocks of 4 with equal volume. For this purpose, first 12 blocks of 4 are prepared (Excel software is used to prepare random arrangements inside each block) and then these blocks are arranged randomly and people are assigned to two groups according to A and B are given This action continues continuously until the sample volume is completed. Also, in order to hide the allocation process, closed envelopes will be used, Blinding description: In this study, participants enter the study after obtaining consent and receiving explanations from two study groups. However, the decision about which group they will participate in will be blinded. Additionally, the assessors who evaluate postoperative pain at specified time intervals will be blinded to whether the patient has been enrolled in either of the groups. 3 Pain after appendectomy. Intervention 1: All patients are first administered intravenous ketamine at a dose of 1.5 milligrams per kilogram in the waiting room to achieve tranquility before being transferred to the operating room. Subsequently, patients receive sevoflurane 6% along with remifentanil at a dose of 0.6 micrograms per kilogram and rocuronium at a dose of 0.6 milligrams per kilogram intravenously, prior to endotracheal intubation. General anesthesia is maintained with the minimal alveolar concentration of sevoflurane and an infusion of remifentanil at a rate of 0.05 micrograms per kilogram per minute.In the intervention group, tap block is performed using 0.2% ropivacaine at a dose of 0.5 milliliters per kilogram, guided by ultrasound at the end of the surgery and before the patient awakens from general anesthesia. All standard pain management protocols are uniformly applied to both groups postoperatively. Intervention 2: All patients are first administered intravenous ketamine at a dose of 1.5 milligrams per kilogram in the preoperative waiting room to achieve tranquility before being transferred to the operating room. Subsequently, patients receive sevoflurane 6% along with remifentanil at a dose of 0.6 micrograms per kilogram and rocuronium at a dose of 0.6 milligrams per kilogram intravenously, prior to endotracheal intubation. General anesthesia is maintained with the minimal alveolar concentration of sevoflurane and an infusion of remifentanil at a rate of 0.05 micrograms per kilogram per minute.. It's important to note that all standard pain management protocols are uniformly applied to both groups postoperatively. 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 It will be done according to the opinion of the research committee of Mashhad University of Medical Sciences.
public Mohadeseh Sabour Darbandi
No. 63, Daneshjou 14,mashhad,iran
Mashhad Iran (Islamic Republic of) 9188961441 +98 51 3864 8137 sabourm991@mums.ac.ir Mashhad University of Medical Sciences scientific Mohadeseh Sabour Darbandi
No. 63, Daneshjou 14,mashhad,iran
Mashhad Iran (Islamic Republic of) 9188961441 +98 51 3864 8137 sabourm991@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patient who candidate for appendectomy Age between 4 to 16 years old Obtaining informed consent from parents to participate the study 4 years 16 years Both Having other comorbidities History of previous surgery Candidate for performing several operations at the same time Abnormal laboratory data High body mass index Perforated appendicitis Allergic reaction to local anesthetics Y48.02 local anesthetics Treatment - Other Treatment - Other All patients are first administered intravenous ketamine at a dose of 1.5 milligrams per kilogram in the waiting room to achieve tranquility before being transferred to the operating room. Subsequently, patients receive sevoflurane 6% along with remifentanil at a dose of 0.6 micrograms per kilogram and rocuronium at a dose of 0.6 milligrams per kilogram intravenously, prior to endotracheal intubation. General anesthesia is maintained with the minimal alveolar concentration of sevoflurane and an infusion of remifentanil at a rate of 0.05 micrograms per kilogram per minute.In the intervention group, tap block is performed using 0.2% ropivacaine at a dose of 0.5 milliliters per kilogram, guided by ultrasound at the end of the surgery and before the patient awakens from general anesthesia. All standard pain management protocols are uniformly applied to both groups postoperatively. All patients are first administered intravenous ketamine at a dose of 1.5 milligrams per kilogram in the preoperative waiting room to achieve tranquility before being transferred to the operating room. Subsequently, patients receive sevoflurane 6% along with remifentanil at a dose of 0.6 micrograms per kilogram and rocuronium at a dose of 0.6 milligrams per kilogram intravenously, prior to endotracheal intubation. General anesthesia is maintained with the minimal alveolar concentration of sevoflurane and an infusion of remifentanil at a rate of 0.05 micrograms per kilogram per minute.. It's important to note that all standard pain management protocols are uniformly applied to both groups postoperatively. Pain after surgery. Timepoint: Every 4 hours till 12 hours after surgery. Method of measurement: Visual Analogue Scale. The total amount of analgesics consumption. Timepoint: 12 hours after surgery. Method of measurement: The total dose of morphine consumption. Mashhad University of Medical Sciences Approved 2023-04-18 Faculty of Medicine, Mashhad University of Medical Sciences (Research Ethics Committee) No 63, 14 Daneshjou Ave, Daneshjou Boulevar, Mashhadd Mashhad Razavi Khorasan Iran (Islamic Republic of)