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IRCT20230204057318N3 IRCT 2023-11-20 Shahid Beheshti University of Medical Sciences Comparison of multimodal analgesia and opioid based method Comparison of multimodal analgesia and opioid based method in urethral reconstruction surgery 2023-11-22 anticipated 30 Complete https://irct.ir/trial/73781 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: For randomization, a simple randomization method was used using a table of random numbers and through the Random generator program of the Android version. In this randomization, patients who meet the criteria for entering the study are assigned a number before anesthesia, which will represent one of the two study groups, Blinding description: The patients, the person responsible for data collection, and the data analyzer will be unaware of how the groups are coded. Only the anesthesiologist in charge of the patient will know about the patient group, but the attending physician will not. 3 Urethral reconstruction surgery. Intervention 1: Intervention group (M): One hour before patients enter the operating room, in group M, a dose of clonidine with a dose of 3 microgram/kg and a dose of gabapentin with a dose of 4 mg/kg will be given orally to the patients. Patients of both groups are put under general anesthesia in the same way. In group M, a dose of dexamethasone with a dose of 8 mg will be prescribed after the start of anesthesia. After the start of anesthesia and before the start of surgery for patients in group M, a bilateral pudendal nerve block will be performed with 10 ml of 0.5% ropivacaine under ultrasound guidance. During surgery for group M, magnesium sulfate infusion will be continued with an initial dose of 30mg/kg and then 15mg/kg/h until the end of the surgery. In order to remove the buccal graft, at the end of the work in group M, 0.25% bupivacaine solution with a volume of 10 mL will be used. At the end of the surgery in group M, a dose of intravenous ketorolac with a dose of 30 mg and a dose of intravenous paracetamol with a dose of one gram will be used. Intervention 2: Control group (S): One hour before the patients enter the operating room, two placebo tablets will be given to the patients orally in the S group. Patients of both groups are put under general anesthesia in the same way. In group S, 2 ml of normal saline (placebo) will be administered after the start of anesthesia. During surgery for group S, normal saline infusion will be used as a placebo until the end of surgery. To perform buccal graft removal, at the end of the work in group S, normal saline solution with a volume of 10 mL will be used. At the end of surgery in group S, morphine with a dose of 0.05mg/kg will be used intravenously. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Alireza Shakeri
Imam Hossein Hospital, Shahid Madani st, Imam Ali Hwy.
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7343 0000 dr.alirezashakeri@gmail.com Shahid Beheshti University of Medical Sciences scientific Alireza Shakeri
Imam Hossein Hospital, Shahid Madani st, Imam Ali Hwy.
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7343 0000 dr.alirezashakeri@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patient candidate for urethral reconstruction treatment Mental health and providing informed consent Ability to adhere to patient visit schedule and other relevant protocols American Society of Anesthesiologist (ASA) score I or II Normal kidney and liver function 18 years no limit Male Any condition that prevents obtaining informed consent. Any other disease, including malignancy, abnormal laboratory tests, psychiatric disease, which in the opinion of the researcher prevents the patient from adhering to the study. Concomitant or uncontrolled illness that, in the researcher's opinion, causes harm to the patient or non-adherence to the study. History of drug addiction, psychoactive drugs and other illegal drug substances N35 Urethral stricture Treatment - Drugs Treatment - Drugs Intervention group (M): One hour before patients enter the operating room, in group M, a dose of clonidine with a dose of 3 microgram/kg and a dose of gabapentin with a dose of 4 mg/kg will be given orally to the patients. Patients of both groups are put under general anesthesia in the same way. In group M, a dose of dexamethasone with a dose of 8 mg will be prescribed after the start of anesthesia. After the start of anesthesia and before the start of surgery for patients in group M, a bilateral pudendal nerve block will be performed with 10 ml of 0.5% ropivacaine under ultrasound guidance. During surgery for group M, magnesium sulfate infusion will be continued with an initial dose of 30mg/kg and then 15mg/kg/h until the end of the surgery. In order to remove the buccal graft, at the end of the work in group M, 0.25% bupivacaine solution with a volume of 10 mL will be used. At the end of the surgery in group M, a dose of intravenous ketorolac with a dose of 30 mg and a dose of intravenous paracetamol with a dose of one gram will be used. Control group (S): One hour before the patients enter the operating room, two placebo tablets will be given to the patients orally in the S group. Patients of both groups are put under general anesthesia in the same way. In group S, 2 ml of normal saline (placebo) will be administered after the start of anesthesia. During surgery for group S, normal saline infusion will be used as a placebo until the end of surgery. To perform buccal graft removal, at the end of the work in group S, normal saline solution with a volume of 10 mL will be used. At the end of surgery in group S, morphine with a dose of 0.05mg/kg will be used intravenously. Perioperative opioid consumption (intraop + postop). Timepoint: intraoperative and postoperative. Method of measurement: Based on the amount of narcotics used and recorded in the patient's file. Intraoperative opioid consumption. Timepoint: Intraoperative. Method of measurement: Patient file information. Postoperative opioid consumption. Timepoint: Postoperative up to 24h. Method of measurement: Patient file information. Postoperative pain. Timepoint: Postoperative up to 24h. Method of measurement: VAS score. Hospitalization days after surgery. Timepoint: Postoperative. Method of measurement: Hospitalization days. Postoperative complications (nausea, vomiting, constipation). Timepoint: Postoperative. Method of measurement: Observation/questionnaire. Intraoperative hemodynamic (HR, MAP). Timepoint: Intraoperative. Method of measurement: Hemodynamic monitoring. Shahid Beheshti University of Medical Sciences Approved 2023-10-29 Ethics Committee of Shahid Beheshti University of Medical Sciences Yaman st., Shahid Chamran Hwy. Tehran Tehran Iran (Islamic Republic of)