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IRCT20170516033992N2 IRCT 2020-10-06 Oroumia University of Medical Sciences The effect of caudal block and penile block in postoperative analgesia of hypospadiasis repair Comparing caudal block and penile block using rectal acetaminophen in postoperative analgesia of hypospadiasis repair 2020-02-23 anticipated 50 Complete https://irct.ir/trial/50862 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will conduct based on permuted block randomization method. Within each block, subjects will be randomly and equally assigned to caudal group (n=25) or penile group (n=25). Random assignment will be done using a random number table. That is, with the help of the Rand () command in Excel, we create random numbers, then we specify the numbers less than 0.5 with P, which means the penile group, and the numbers more than 0.5 with Q, which means the caudal group. The created sequence is random and the blocks continue until the number of samples is completed, Blinding description: Patients were unaware of their placement in the intervention groups and the clinical assessor was unaware of the placement of patients in the study groups and the statistical analyzer received the data in code, not the actual grouping. 3 Hypospadias. Intervention 1: Intervention group 1: This group of patients underwent caudal block in the lateral decubitus position with needle 22 Guage from the sacral space of hiatus with 1 ml of bupivacaine 0.25% (British-Swedish company of AstraZeneca ) and epinephrine with a concentration of 1/200000 (5 μg / kg). In fact, this intervention is a kind of regional anesthesia procedure through the caudal region. The group was under general anesthesia, but caudal was also performed for postoperative analgesia. Intervention 2: Intervention group 2: In the penile block group, after general anesthesia with the condition of the caudal block group in the supine position under the penile block with a needle 22 Guage and bupivacaine 0.25%, 0.1 ml / kg from two sites in the retro-pubic space under the fascia of the book was performed. Acetaminophen suppository was administered at a dose of 40 mg / kg before surgery. Yes - There is a plan to make this available What will be shared: Information can be provided without patients' names When: 1 سال پس از اتمام مطالعه To whom: Faculty researchers Conditions: Sending email to DR. Tohid Karami Where to obtain: Sending email to DR. Tohid Karami How to obtain: Just sending email to DR. Tohid Karami Comments:
public Tohid Karami
Jahad Sq., Resalat st., Urmia University of Medical Sciences
Urmia Iran (Islamic Republic of) 5715833631 +98 44 3193 7000 karami.tohid@gmail.com Oroumia University of Medical Sciences scientific Tohid Karami
Jahad Sq., Resalat st., Urmia University of Medical Sciences
Urmia Iran (Islamic Republic of) 5715833631 +98 44 3193 7000 karami.tohid@gmail.com Oroumia University of Medical Sciences Iran (Islamic Republic of) Age between 6 months to 5 years Absence of spinal deformity ASA class ≤II Children need hypospadias repair 6 months 5 years Male Coagulation problems Severe infections such as septicemia, meningitis Brain tumors with increased intracranial pressure Real sensitivity to local anesthetics Chemotherapy Unmodified hypovolemia Q54 Hypospadias Treatment - Other Treatment - Other Intervention group 1: This group of patients underwent caudal block in the lateral decubitus position with needle 22 Guage from the sacral space of hiatus with 1 ml of bupivacaine 0.25% (British-Swedish company of AstraZeneca ) and epinephrine with a concentration of 1/200000 (5 μg / kg). In fact, this intervention is a kind of regional anesthesia procedure through the caudal region. The group was under general anesthesia, but caudal was also performed for postoperative analgesia. Intervention group 2: In the penile block group, after general anesthesia with the condition of the caudal block group in the supine position under the penile block with a needle 22 Guage and bupivacaine 0.25%, 0.1 ml / kg from two sites in the retro-pubic space under the fascia of the book was performed. Acetaminophen suppository was administered at a dose of 40 mg / kg before surgery. Pain. Timepoint: In recovery, 6, 12 and 24 hours after surgery. Method of measurement: The face, legs, activity, cry, consolability (FLACC) scale. Oroumia University of Medical Sciences Approved 2020-02-18 Ethics committee of Urmia University of Medical Sciences Jahad Sq., Resalat St., Urmia University of Medical Sciences Urmia West Azarbaijan Iran (Islamic Republic of)