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IRCT20130304012695N13 IRCT 2022-07-08 Tehran University of Medical Sciences Comparison of Diphenhydramine injection at wound edge and lidocaine In reducing pain after open kidney surgery Infiltration of Diphenhydramine versus subcutaneous Lidocaine at the wound site to reduce pain after open renal surgeries 2022-07-11 anticipated 60 Complete https://irct.ir/trial/63330 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to randomize, a random block method will be used. For this purpose, we formed blocks of size 4. In each block, 2 individuals will be in intervention group 1 and 2 will be in intervention group 2. A total of 20 blocks will be considered for the study. All possible blocks are arranged as follows: block 1: ABAB block 2: AABB block 3: ABBA block 4: BBAA block 5: BABA block 6: BAAB We need 20 blocks to select 80 people. We randomly select these blocks from 1 to 6. Using the software, we choose a random number between the numbers 1 to 6. For example, if the number 6 is selected as the first block and the number 2 as the second block, the people who enter the study will be given BAABAABB, respectively. Finally, group A receives control intervention and group B receives treatment intervention, Blinding description: In this study, patients do not know their group.Eligible participants were assigned to receive either lidocaine (group L) 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 diphenhydramine. Intervention 1: Intervention group: 10 ml of normal saline, which contains Diphenhydramine (rahapharm company )10 milligrams per milliliter, is prepared with the help of an anesthesiologist 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) will be used for postoperative analgesia. Intervention 2: Control group: 10 ml of normal saline, which contains Lidocaine (made by Caspian Tamin company )10 milligrams per milliliter, is prepared with the help of an anesthesiologist 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,Imam Khomeini Street
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 sleep Apnea History of addiction to drugs or other psychotropic substances History of acute drug or alcohol poisoning History of psychological disorder Treatment - Drugs Treatment - Drugs Intervention group: 10 ml of normal saline, which contains Diphenhydramine (rahapharm company )10 milligrams per milliliter, is prepared with the help of an anesthesiologist 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) will be used for postoperative analgesia. Control group: 10 ml of normal saline, which contains Lidocaine (made by Caspian Tamin company )10 milligrams per milliliter, is prepared with the help of an anesthesiologist 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. 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. 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. 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. Tehran University of Medical Sciences Approved 2022-06-01 Research Ethics Committees of Sina Hospital ,Tehran University of Medical Sciences Sinai Hospital,Imam Khomeini street Tehran Tehran Iran (Islamic Republic of)