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IRCT20130304012695N14 IRCT 2022-09-04 Tehran University of Medical Sciences Comparison of Ropivacaine-Dexmedetomidine infiltration with Ropivacaine at the wound edge in reducing pain after open kidney surgeries. Comparison of subcutaneous infiltration of Dexmedetomidine plus Ropivacaine and Ropivacaine alone in the surgical wound site in reducing pain after kidney surgery with flank incision. 2022-10-02 anticipated 60 Complete https://irct.ir/trial/65569 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For the randomization of patients who meet the inclusion criteria, the method of four blocks including intervention and control groups will be used.The preparation of randomization sequences will be done using the Random Generator software and the created sequences will be given to a trained staff member of the operating room who is not a member of the research group.The researchers of this study will not be aware of the existing sequences and arrangement of the blocks.After the patient enters the operating room, the trained person removes the first sequence from the special box of this study and according to the predetermined protocol, if it is D, it will be transferred to the intervention group, and if it is C, it will be transferred to the control group, Blinding description: In this study, patients do not know their group.Eligible participants were assigned to receive either Ropivacaine (group R) or Diphenhydramine as (group D) according to a computer-generated randomization schedule. These medications are prepared in identical syringes and volumes and are identified with the patient name and hospital registration number. At the end of the surgery, these drugs are given to the surgeon for injection, who is blinded to the allocation groups. Another researcher who is blinded to the assigned group will assess the severity of pain in the recovery room and ward. 2-3 local anesthetic effect of Dexmedetomidine. Intervention 1: Control group: 20 ml of ROPIVACAINA 0.5%, (made by Molteni company Italia) is prepared with the help of a neurse of anesthesiology according to the patient's grouping, and the surgeon injects it under the skin before completely closing the wound on both sides of the wound edge.After wound closure and endotracheal tube extubation, the patient was transferred to the recovery room, and data about the study variables is collected in the recovery and ward section.If patients have severe pain, morphine (made by Caspian Tamin company) will be used for postoperative analgesia. Intervention 2: Intervention group: 20 ml of ROPIVACAINA 0.5%, (made by Molteni company Italia)along plus100 micrograms of dexmedetomidin (manufactured by Darou Darman Arang factory) is prepared with the help of a neurse of anesthesiology according to the patient's grouping, and the surgeon injects it under the skin before completely closing the wound on both sides of the wound edge.After wound closure and endotracheal tube extubation, the patient was transferred to the recovery room, and data about the study variables is collected in the recovery and ward section.If patients have severe pain, morphine (made by Caspian Tamin company) will be used for postoperative analgesia. Yes - There is a plan to make this available What will be shared: Main study outcome data When: Six months after the end of the study To whom: University researchers Conditions: Share experiences to increase the knowledge Where to obtain: khajavim@tums.ac.ir -Dr.khajavi How to obtain: The request will be made by email and the answer will be given within two months Comments:
public Mohammadreza Khajavi
Sina Hospital,Immam Khominie St
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6312 1220 khajavim@tums.ac.ir Tehran University of Medical Sciences scientific Mohammadreza Khajavi
Sinai Hospital,Imam Khomeini Street
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6312 1220 khajavim@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Patients who have the consent to participate in the study Patients who are candidates for open kidney surgery 20 years 70 years Both History of allergies to the drugs used History of addiction to drugs or other psychotropic substances History of psychological disorder Treatment - Drugs Treatment - Drugs Control group: 20 ml of ROPIVACAINA 0.5%, (made by Molteni company Italia) is prepared with the help of a neurse of anesthesiology according to the patient's grouping, and the surgeon injects it under the skin before completely closing the wound on both sides of the wound edge.After wound closure and endotracheal tube extubation, the patient was transferred to the recovery room, and data about the study variables is collected in the recovery and ward section.If patients have severe pain, morphine (made by Caspian Tamin company) will be used for postoperative analgesia. Intervention group: 20 ml of ROPIVACAINA 0.5%, (made by Molteni company Italia)along plus100 micrograms of dexmedetomidin (manufactured by Darou Darman Arang factory) is prepared with the help of a neurse of anesthesiology according to the patient's grouping, and the surgeon injects it under the skin before completely closing the wound on both sides of the wound edge.After wound closure and endotracheal tube extubation, the patient was transferred to the recovery room, and data about the study variables is collected in the recovery and ward section.If patients have severe pain, morphine (made by Caspian Tamin company) will be used for postoperative analgesia. Total analgesics consumption during the first 24 hr after surgery. Timepoint: One time at the end of the first 24 hours after operation. Method of measurement: According to the patient file and nursing report. When was the first need for analgesics. Timepoint: During 6 hours after surgery. Method of measurement: In terms of time per minute, and according to the first time after extubation of patients, the analgesic is injected. Acute Postoperative Pain. Timepoint: In recovery room and 1,6,12,18 and 24 hours after surgery. Method of measurement: Visual Analog Scale(VAS score). Agitation and Sedation degree. Timepoint: In recovery room and 1,6,12,18 and 24 hours after surgery. Method of measurement: Ramsy Sedation Scale. Tehran University of Medical Sciences Approved 2022-06-22 Research Ethics Committees of Sina Hospital ,Tehran University of Medical Sciences Sinai Hospital,Imam Khomeini street Tehran Tehran Iran (Islamic Republic of)