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IRCT20200521047530N3 IRCT 2023-08-25 Tehran University of Medical Sciences Comparative study of analgesic quality in two methods of bilateral ilioinguinal block and caudal block Comparative study of analgesic quality in two methods of bilateral illioinguinal block and caudal block with rupivacaine 0.2% in patients aged 3 to 8 years undergoing bilateral inguinal hernia surgery under general anesthesia in the Childern's Medical Center Hospital, 2021-22 2021-06-22 anticipated 66 Complete https://irct.ir/trial/56507 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The sample will be identified by the randomization (restricted randomization) block method with 6 blocks and using a random number table of Random Allocation Software. The randomization tool is the random sequence generation software version 2.0, it will be available from the following address:(http://random.allocation software, version 2.0). Allocation concealment will be used to execute random sequences on participants. Each random sequence generated will be recorded on a card and the cards will be sealed in opaque envelopes. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface, and finally the letter envelopes are glued and placed in a box respectively. Registration of participants, based on the order of entry of eligible participants into study, one of the envelopes of the letter is opened in order and the assigned group of the participant is revealed, Blinding description: A person who records the severity of pain and the patient does not know the type of block. The double blindness of the study will be done this way. 3 Bilateral inguinal hernia surgery. Intervention 1: Intervention group 1: Patient under bilateral ilioinguinal block with rupivacaine 0.2%( manufactured by MOLTENI farmaceutici) under ultrasound guide. After determining the sedation score according to Ramsay criteria, patients are directed to the operating room. After installing standard monitoring equipment and obtaining a peripheral vein, 2 mg/kg sodium thiopental and 1 μg/kg fentanyl m is prescribed. Induction of anesthesia will be done by mapleson and under spontaneous inhalation. sevoflurane 8% and 100% oxgygen will be used in induction. After endotracheal tube insertion, maintenance of anesthesia will be provided by 100% oxygen and isoflurane 2.5%. After induction of anesthesia, heart rate and mean arterial pressure will be measured and recorded.In performing ilio-inguinal block, the child is in the supine position and after prep and drape a short 24G needle will be used. Rupivacaine 0.2% at a dose of 0.1 ml / kg will be used for drug injection. In case of increased heart rate or systolic blood pressure after incision by more than 20% of basal values, fentanyl will be repeated and recorded at a dose of 1 μg /kg. After surgery, the patient's pain intensity will be assessed using the CHEOPS criteria and the delirium score will be assessed by PAED score. In post anesthesia care unit, patients with CHEOPS pain score greater than 10 will be prescribed 1 of fentanyl μg /kg.Rupivacaine is from the Bioindustria L.i.m.s.p.a brand. Intervention 2: Intervention group 2: Patients under caudal block with rupivacaine 0.2%. After determining the sedation score according to Ramsay criteria, patients are directed to the operating room. After installing standard monitoring equipment and obtaining a peripheral vein, 2 mg/kg sodium thiopental and 1 μg/kg fentanyl m is prescribed. Induction of anesthesia will be done by mapleson and under spontaneous inhalation. sevoflurane 8% and 100% oxgygen will be used in induction. After endotracheal tube insertion, maintenance of anesthesia will be provided by 100% oxygen and isoflurane 2.5%. After induction of anesthesia, heart rate and mean arterial pressure will be measured and recorded./In performing ilio-inguinal block, the child is in the supine position and after prep and drape a short 24G needle will be used. Rupivacaine 0.2% at a dose of 0.1 ml. In the second group, the child is in a lateral position,The hip will flex and the lower leg will flex. After prep and drape, a short 24G needle was used Rupivacaine 0.2% at a dose of 1 ml / kg will be used.In case of increased heart rate or systolic blood pressure after incision by more than 20% of basal values, fentanyl will be repeated and recorded at a dose of 1 μg /kg. After surgery, the patient's pain intensity will be assessed using the CHEOPS criteria and the delirium score will be assessed by PAED score. In post anesthesia care unit, patients with CHEOPS pain score greater than 10 will be prescribed 1 of fentanyl μg /kg. Yes - There is a plan to make this available What will be shared: The documents will be published in general and in the form of articles. When: The data will be provided after the publication of the article. To whom: Researchers at academic institutions can generally access study data. Conditions: Researchers are allowed to use the data only by citing the source and referring to the present study. Where to obtain: Dr. Nima Nazari/ E-mail: Nima.nazari1366@gmail.com How to obtain: After requesting the person in charge via email, the data will be provided to the researchers. Comments:
public Nima Nazari
Children's Medical Center Hospital, Dr,Gharib St, Keshavarz Blv
Tehran Iran (Islamic Republic of) 1419733151 00982161479 n-nazari@sina.tums.ac.ir Tehran University of Medical Sciences scientific Nima Nazari
Children's Medical Center Hospital, Dr.Gharib St, Keshavarz Blv
Tehran Iran (Islamic Republic of) 1419733151 00982161479 n-nazari@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) All children from 3 to 8 years old Candidate for bilateral inguinal hernia surgery Under general anesthesia ASA class 1 and 2 3 years 8 years Both Allergy to local anesthetics Non-Persian speaking patients Sacral infection Coagulation disorders History of seizures Weight more than 20 kg Patients who are being treated with a variety of painkillers and psychiatric medications for any reason Treatment - Drugs Treatment - Drugs Intervention group 1: Patient under bilateral ilioinguinal block with rupivacaine 0.2%( manufactured by MOLTENI farmaceutici) under ultrasound guide. After determining the sedation score according to Ramsay criteria, patients are directed to the operating room. After installing standard monitoring equipment and obtaining a peripheral vein, 2 mg/kg sodium thiopental and 1 μg/kg fentanyl m is prescribed. Induction of anesthesia will be done by mapleson and under spontaneous inhalation. sevoflurane 8% and 100% oxgygen will be used in induction. After endotracheal tube insertion, maintenance of anesthesia will be provided by 100% oxygen and isoflurane 2.5%. After induction of anesthesia, heart rate and mean arterial pressure will be measured and recorded.In performing ilio-inguinal block, the child is in the supine position and after prep and drape a short 24G needle will be used. Rupivacaine 0.2% at a dose of 0.1 ml / kg will be used for drug injection. In case of increased heart rate or systolic blood pressure after incision by more than 20% of basal values, fentanyl will be repeated and recorded at a dose of 1 μg /kg. After surgery, the patient's pain intensity will be assessed using the CHEOPS criteria and the delirium score will be assessed by PAED score. In post anesthesia care unit, patients with CHEOPS pain score greater than 10 will be prescribed 1 of fentanyl μg /kg.Rupivacaine is from the Bioindustria L.i.m.s.p.a brand. Intervention group 2: Patients under caudal block with rupivacaine 0.2%. After determining the sedation score according to Ramsay criteria, patients are directed to the operating room. After installing standard monitoring equipment and obtaining a peripheral vein, 2 mg/kg sodium thiopental and 1 μg/kg fentanyl m is prescribed. Induction of anesthesia will be done by mapleson and under spontaneous inhalation. sevoflurane 8% and 100% oxgygen will be used in induction. After endotracheal tube insertion, maintenance of anesthesia will be provided by 100% oxygen and isoflurane 2.5%. After induction of anesthesia, heart rate and mean arterial pressure will be measured and recorded./In performing ilio-inguinal block, the child is in the supine position and after prep and drape a short 24G needle will be used. Rupivacaine 0.2% at a dose of 0.1 ml. In the second group, the child is in a lateral position,The hip will flex and the lower leg will flex. After prep and drape, a short 24G needle was used Rupivacaine 0.2% at a dose of 1 ml / kg will be used.In case of increased heart rate or systolic blood pressure after incision by more than 20% of basal values, fentanyl will be repeated and recorded at a dose of 1 μg /kg. After surgery, the patient's pain intensity will be assessed using the CHEOPS criteria and the delirium score will be assessed by PAED score. In post anesthesia care unit, patients with CHEOPS pain score greater than 10 will be prescribed 1 of fentanyl μg /kg. Pain score based on CHEOPS criteria. Timepoint: After the patient enters the recovery ward, the pain score is recorded. Method of measurement: Children's Hospital of Eastern Ontario Pain Scale. PAED Delirium Score. Timepoint: After the patient enters the recovery ward, it is recorded. Method of measurement: It is obtained based on The Pediatric Anesthesia Emergence Delirium criteria. Recovery time. Timepoint: It is recorded and calculated between the time the patient enters the recovery ward and the patient leaves it. Method of measurement: It is recorded and calculated between the time the patient enters the recovery ward and the patient leaves it. Need for additional drugs (fentanyl). Timepoint: Additional dose of fentanyl prescribed after surgical incision or in the recovery ward. Method of measurement: Additional dose of fentanyl prescribed after surgical incision or in the recovery ward in micrograms per kilogram. Tehran University of Medical Sciences Approved 2021-03-30 Research Etichs Committee of Tehran University Of Medical Sciences Qods St, Keshavarz Blv Tehran Tehran Iran (Islamic Republic of)