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IRCT20090129001615N9 IRCT 2023-12-02 Esfahan University of Medical Sciences The effect of combination of dexmedetomidine-bupivacaine with ketamine-bupivacaine on post poerative pain after lower abdominal surgeries The effect of preemptive subcutaneous infiltration of dexmedetomidine-bupivacaine combination with ketamine-bupivacaine combination on pain after lower abdominal surgeries 2023-09-22 anticipated 90 Complete https://irct.ir/trial/72509 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is done Random Allocation software. In this soft ware , the total number of samples and the number of groups are entered into the software. The output of the software is a list including three groups A, B and C, which has randomly distributed patients by number among the three groups. According to the mentioned list, patients are divided into three groups according to the time of entering the operating room, so that the sample volume reaches the required number in each group, Blinding description: The injected drug are prepared by the researcher and injected to the patients. The patients, the person collecting the drugs and the person analyzing the data will be unaware of the type of drug combination injected to the patients. 3 anesthesia. Intervention 1: Intervention group 1: recipient of 40 cc bupivacaine 0.25% (made by Exir institutein) combination with dexmedetomidine 1.5 µg/kg (made by Imozhen institute) before surgical incision. Intervention 2: Intervention group2: recipient of 40 cc bupivacaine 0.25% (made by Exir institutein) in combination with ketamine 2µg/kg(made by Rutex institute). Intervention 3: Control group: recipient of 40 cc of normal saline(made by Razi institute) as infiltration at the surgical incision site. No - There is not a plan to make this available Justification or reason for not sharing IPD is The plan belongs to the government organization and it is not possible to share it
public Ali Mehrabi Koushki
Hezar Jerib street
Isfahan Iran (Islamic Republic of) 8434193474 +98 31 3668 2974 al.mehrabi@gmail.com Esfahan University of Medical Sciences scientific Azim Honarmand
Sofeh street
Isfahan Iran (Islamic Republic of) 8434193474 +98 31 3668 2174 honarmand@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) atients who are candidates for elective lower abdominal surgery Age range 18-65 years ASA 1 or 2 18 years 65 years Both Patients with a history of allergy to the studied drugs (dexmedetomidine, ropivacaine, and ketamine) Patients with a history of drug addiction Patients with mental health problems Obese patients weighing more than 100 kg Patients with inability to express pain intensity based on VAS criteria Infection at the surgical incision site Any change in anesthesia method Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1: recipient of 40 cc bupivacaine 0.25% (made by Exir institutein) combination with dexmedetomidine 1.5 µg/kg (made by Imozhen institute) before surgical incision Intervention group2: recipient of 40 cc bupivacaine 0.25% (made by Exir institutein) in combination with ketamine 2µg/kg(made by Rutex institute) Control group: recipient of 40 cc of normal saline(made by Razi institute) as infiltration at the surgical incision site Post operatie pane. Timepoint: Every 15 minutes during recovery and at 2, 6, 12 and 24 hours after the operation. Method of measurement: With using vigual analog scale. Esfahan University of Medical Sciences Approved 2022-11-15 Ethics committee of Isfahan University of Medical Sciences Hezar Jerib Street Isfahana Isfehan Iran (Islamic Republic of)