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IRCT20230506058100N2 IRCT 2023-09-16 Iran University of Medical Sciences Comparison of the analgesia effect of two types of abdominal block in children candidates for lower abdominal surgeries Comparison of the analgesic effect of ultrasound-guided posterior quadratus lumborum block and ultrasound-guided ilioinguinal/iliohypogastric nerve block for pediatric lower abdominal surgery: A Prospective, randomized double-blinded study 2023-10-23 anticipated 60 Complete https://irct.ir/trial/72258 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, simple and individual randomization method is used.The Sealed Envelope site is used to generate random sequences. The website address is https://www.sealedenvelope.com.Each of the generated random sequences contains a unique code for hiding.First, using a computer program, such as Microsoft Excel or SAS, a sequence of random numbers will be generated Then, based on the randomization sequence, the participants will be assigned to 2 quadratus lumborum block groups and ilioinguinal/iliohipogaster block groups, And by using sealed envelopes, this allocation will be hidden, And the participants will be assigned to the appropriate groups according to the order of allocation, Blinding description: Blinding the patient: due to their condition and being unconscious, the patients are unaware of the treatment process and the patient's companion does not know which method was used for the disease. Blinding of the outcome assessor: Data collectors will not be aware of the type of block and management during surgery and postoperative evaluation and will record all hemodynamic items, questionnaire interventions, and postoperative evaluations. 3 pediatric candidates for lower abdominal surgeries. Intervention 1: Intervention group:In group 1 or quadratus lumbarum group, where the posterior approach is selected, the patient will be lateralized and the side that is not operated on will be placed on the bed,The ultrasound probe will be placed in the midaxillary line between the rib edge and the iliac crest,After identifying the three layers of abdominal muscles, the probe is guided posteriorly until the external oblique and intertal oblique muscles reach the quadratus lumborum muscle.Then, needle number 22 is inserted with in-plane approach from front to back. The goal of the needle tip is to reach between the quadratus lumborum muscle and the erector spinea muscle, where the middle part of the thoracolumbar fascia reaches the posterior surface of the quadratus lumborum muscle.First, to confirm the correct location of the needle tip, 0.5cc of normal saline will be injected, and then 0.5cc/kg of ropivacaine 0.2% will be injected after negative aspiration. Intervention 2: Intervention group:In group 2 or ilioinguinal/iliohypogastric block group, in the supine position, we will place the ultrasound probe above the superior anterior sphincter, in alignment with the space between the navel and the superior anterior sphincter, so that three layers of muscle can be seen clearly,Then we find the ilioinguinal/iliohypogastric nerves in the form of two hypoechoic structures between the internal oblique muscle and the transverse abdominis and after preparation and drape and under sterile conditions, we insert the needle from the medial to the lateral side with an in-plane approach and near the nerves, first 0.5cc of normal saline will be injected to confirm the correct location, and after confirming the location and performing negative aspiration, 0.2cc/kg of ropivacaine 0.2% will be slowly injected around the nerve. 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 There is no further information
public Tahereh Chavoshi
No.193, Zafar st, Modares Highway
Tehran Iran (Islamic Republic of) 1919816766 +98 21 2304 6252 chavoshi.t@iums.ac.ir Iran University of Medical Sciences scientific Tahereh Chavoshi
No. 193, Zafar st, Moddares Highway
Tehran Iran (Islamic Republic of) 1919816766 +98 21 2304 6252 Chavoshi.t@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Candidate patients for unilateral inguinal hernia surgery and unilateral orchiopexy In the age range of 4 to 12 years Having informed consent from parents 4 years 12 years Both History of surgery in the block area Coagulation disorder ASA class three and above Opium use before surgery Sensitivity to local anesthetics Infection or redness at the injection site Liver, kidney and heart diseases Children with cerebral palsy Treatment - Surgery Treatment - Surgery Intervention group:In group 1 or quadratus lumbarum group, where the posterior approach is selected, the patient will be lateralized and the side that is not operated on will be placed on the bed,The ultrasound probe will be placed in the midaxillary line between the rib edge and the iliac crest,After identifying the three layers of abdominal muscles, the probe is guided posteriorly until the external oblique and intertal oblique muscles reach the quadratus lumborum muscle.Then, needle number 22 is inserted with in-plane approach from front to back. The goal of the needle tip is to reach between the quadratus lumborum muscle and the erector spinea muscle, where the middle part of the thoracolumbar fascia reaches the posterior surface of the quadratus lumborum muscle.First, to confirm the correct location of the needle tip, 0.5cc of normal saline will be injected, and then 0.5cc/kg of ropivacaine 0.2% will be injected after negative aspiration. Intervention group:In group 2 or ilioinguinal/iliohypogastric block group, in the supine position, we will place the ultrasound probe above the superior anterior sphincter, in alignment with the space between the navel and the superior anterior sphincter, so that three layers of muscle can be seen clearly,Then we find the ilioinguinal/iliohypogastric nerves in the form of two hypoechoic structures between the internal oblique muscle and the transverse abdominis and after preparation and drape and under sterile conditions, we insert the needle from the medial to the lateral side with an in-plane approach and near the nerves, first 0.5cc of normal saline will be injected to confirm the correct location, and after confirming the location and performing negative aspiration, 0.2cc/kg of ropivacaine 0.2% will be slowly injected around the nerve. Pain score. Timepoint: 30 minutes after transferring to the recovery room and 1, 2, 4, 6, 12, 24 hours after the operation. Method of measurement: Number based on Falcc Score. Iran University of Medical Sciences Approved 2023-08-21 کمیته اخلاق دانشگاه علوم پزشکی ایران Iran University of Medical Sciences, Next to Milad Tower; Shahid Hemat Highway Tehran Tehran Iran (Islamic Republic of)