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IRCT20190730044383N1 IRCT 2020-02-18 Tabriz University of Medical Sciences Comparison of efficacy of different nerve block with ultrasonic guide for postoperative pediatric pain management Comparison of efficacy of transversus abdominis plane block and iliohypogastric/ilioinguinal ultrasonic block for postoperative pain management in pediatric patients 2019-09-18 anticipated 50 Complete https://irct.ir/trial/41189 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be a layer randomization such that depending on patient ID , if the ID is an even number, ultrasound guidance TAP block will be conducted for him/her and if it is odds number, the ultrasound guidance IIN / IHN block will be done, Blinding description: The head of the operating room of the Tabriz Pediatric Hospital will be aware of this. During surgery and after recovery, the examiner will examine the patient and record the relevant criteria for the patient without knowing which treatment method is selected. The statistical analyzer is also unaware of the block method and therefore will be a triple blind study.The surgery was the same in both groups but the analgesic method differed in both groups. depending on patient ID , if the ID is an even number, ultrasound guidance TAP block will be conducted for him/her and if it is odds number, the ultrasound guidance IIN / IHN blockwill be done. And since the anesthesiologist will proceed with the procedure according to the file number, so he or she will not be aware of the child's grouping, so the parents of the child are also unaware of the type of block. N/A Comparison of the efficacy of abdominal transverse muscle block block with ileohypogastric / ileoengyngal block. Intervention 1: Intervention group: in this group ultrasound probe is placed transversely in midaxillary line, between iliac crest and inferior rib margins. After ultrasonographic view of abdominal wall layer is obtained , Needle guge of 20 or 22 (according to the child's age) is inserted medial to the lateral plane and after reaching the needle tip to the fascia between the IO and TA muscles 0.4ml / kg of 0.25% bupivacaine solution (ie 1mg). / kg) will be injected. In case of bilateral inguinal hernia repair (or surgical incision beyond the midline of the body), in each case, the above-mentioned area blocks will be bilateral. In all of the above, the dose of topical anesthesia drugs should not exceed toxic dosage (2mg / kg bupivacaine). Intervention 2: Control group: In this group the ultrasound probe is placed transversely in center of imaginary line between anterior superior iliac spine and navel and the lateral end of the probe adheres to the anterior superior iliac spine Needle score of 20 or 22 (according to child's age) is in-plane medially lateral to body and after needle tip reached to fascia between IO and TA muscles 0.2ml / kg of 0.25% bupivacaine solution (ie 0.5 mg / kg) will be injected in the vicinity of the above nerves and a "Kayak" view or mark will be obtained. 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 No more information.
public Behzad Sharbiani
Golghast St., Azadi St ،Tabriz
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3336 3176 sharabiani48@gmail.com Tabriz University of Medical Sciences scientific Arefeh Khanghlan
Golghast St., Azadi St ،Tabriz
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3336 3176 Arefe6876@gmil.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Children aged 6-12 years old Children with ASA Class I and II requiring inguinal hernia repair 6 years 12 years Both Parental dissatisfaction with performing regional block Allergy to local anesthesia will be ندارد ندارد Treatment - Surgery Treatment - Surgery Intervention group: in this group ultrasound probe is placed transversely in midaxillary line, between iliac crest and inferior rib margins. After ultrasonographic view of abdominal wall layer is obtained , Needle guge of 20 or 22 (according to the child's age) is inserted medial to the lateral plane and after reaching the needle tip to the fascia between the IO and TA muscles 0.4ml / kg of 0.25% bupivacaine solution (ie 1mg). / kg) will be injected. In case of bilateral inguinal hernia repair (or surgical incision beyond the midline of the body), in each case, the above-mentioned area blocks will be bilateral. In all of the above, the dose of topical anesthesia drugs should not exceed toxic dosage (2mg / kg bupivacaine) Control group: In this group the ultrasound probe is placed transversely in center of imaginary line between anterior superior iliac spine and navel and the lateral end of the probe adheres to the anterior superior iliac spine Needle score of 20 or 22 (according to child's age) is in-plane medially lateral to body and after needle tip reached to fascia between IO and TA muscles 0.2ml / kg of 0.25% bupivacaine solution (ie 0.5 mg / kg) will be injected in the vicinity of the above nerves and a "Kayak" view or mark will be obtained. The amount of pain. Timepoint: 6 to 12 months after surgery. Method of measurement: visual analogue scale. The amount of used analgesic drug. Timepoint: recovery period. Method of measurement: Questionnaire. The time it takes to do the block. Timepoint: during the procedure. Method of measurement: Questionnaire. The time that patient needs the first analgesic drug. Timepoint: during recovery. Method of measurement: Questionnaire. Tabriz University of Medical Sciences Approved 2019-07-30 Ethics Committee of Tabriz Medical School Imam Reza Hospital, Golghast street, Azadi street, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)