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IRCT20190511043550N3 IRCT 2022-01-12 Shiraz University of Medical Sciences The efficacy of Ropivacaine Local Injection on Postoperative Pain in Patients with tonsillectomy surgery The efficacy of Ropivacaine Local Injection on Postoperative Pain in Patients with tonsillectomy surgery 2021-12-26 anticipated 99 Complete https://irct.ir/trial/60105 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, we will use the block randomization method. Samples (99 patients) by random block method with 9 blocks (including 33 participants in intervention group 1 and 33 participants in intervention group 2 and 33 participants in the control group) with The use of a table of random numbers extracted from the relevant software will be specified. The blocks are equal and blocking and the ability to assign a random number for concealment by a non-involved person in the research will be done by recording the numbers on non-transparent envelopes, then based on the obtained blocks and the sequence of drug allocation in the operating room This is a double-blind study, Blinding description: Topical injection of ropivacaine solution or placebo is done by grouping and all cases by a surgeon who is blind to the study to minimize errors in the procedure. Randomization will be performed by a nurse who has no role in data collection. 3 Tonsillectomy. Intervention 1: َIntervention group 1: In this group, 33 patients will inject 3 mg/kg of 1% ropivacaine made by Molteni (equivalent to 5 ccs) 5 minutes before tonsillectomy and 5 ccs of Distilled water 5 minutes after tonsillectomy. Intervention 2: َIntervention group 2:In this group, 33 patients will be injected with 5 ccs of distilled water for 5 minutes before tonsillectomy and 5 ccs of 1% ropivacaine solution (manufactured by Multeni) after tonsillectomy. Intervention 3: Group 3 or control group: In this group, 33 patients will be injected with 5 ccs of distilled water for 5 minutes before tonsillectomy and 5 ccs of distilled water after tonsillectomy. 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 more information
public peyman
Anesthesiology Department, Faghihi Hospital, Zand Street
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3630 4312 peymanhassanpoor@gmail.com Shiraz University of Medical Sciences scientific Ashkan panah
Khalili st
Shiraz Iran (Islamic Republic of) ۱۴۳۳۶۷۱۳۴۸ +98 71 3629 1470 panah@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Patients who are candidates for elective tonsillectomy All patients with chronic tonsillitis with obstructive symptoms without responding to medical treatment who are candidates for adenotonsillectomy Age 5 to 12 years Satisfaction with participating in a research project 5 years 12 years Both History of Coagulation disorders History of Rupivacaine allergy Weight less than 15 kg Children with heart disease Children with kidney disease Children with liver disease Children with respiratory disease Children with mental disabilities J35.01 Chronic tonsillitis Treatment - Drugs Treatment - Drugs Placebo َIntervention group 1: In this group, 33 patients will inject 3 mg/kg of 1% ropivacaine made by Molteni (equivalent to 5 ccs) 5 minutes before tonsillectomy and 5 ccs of Distilled water 5 minutes after tonsillectomy. َIntervention group 2:In this group, 33 patients will be injected with 5 ccs of distilled water for 5 minutes before tonsillectomy and 5 ccs of 1% ropivacaine solution (manufactured by Multeni) after tonsillectomy. Group 3 or control group: In this group, 33 patients will be injected with 5 ccs of distilled water for 5 minutes before tonsillectomy and 5 ccs of distilled water after tonsillectomy. Postoperative pain. Timepoint: From the moment of entering the recovery, 1, 4, 8, 16, 24 hours after entering the recovery room. Method of measurement: Postoperative pain is measured using the Faces Pain Rating Scale at intervals of 1, 4, 8, 16, 24 hours after entering the recovery room by a trained nurse who is unaware of the injectable drug. After the patient is discharged, the trained nurse teaches one of the patient's first-class members in the recovery room and ward in the first few hours how to measure the pain, and records it with their help, and completes the rest at home and by phone at The relevant file is inserted. The effect of rupivacaine injection before and after tonsillectomy on the need for acetaminophen suppositories. Timepoint: From the moment of entering the recovery, 1, 4, 8, 16, 24 hours after entering the recovery room. Method of measurement: Faces pain Rating scale. Shiraz University of Medical Sciences Approved 2021-10-11 Ethics Committee of Shiraz University of Medical Sciences Vice Chancellor of research, Shiraz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street Shiraz Fars Iran (Islamic Republic of)