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IRCT20200825048515N39 IRCT 2021-09-20 Esfahan University of Medical Sciences The effect of topical injection of "morphine, triamcinolone and lidocaine" and "lidocaine alone" on postoperative pain intensity Evaluation of the effect of topical injection of "morphine, triamcinolone and lidocaine" in comparison with "lidocaine" on pain intensity after mastoidectomy-tympanoplasty 2021-09-23 anticipated 68 Complete https://irct.ir/trial/57931 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 68 eligible patients will be randomly selected. Then random numbers are created by computer software "Random Allocation". We randomly divide these numbers into two parts. Each number is written on paper and placed in an envelope. Then each patient is asked to choose an envelope from among the envelopes. According to the selected envelope, the patient will be assigned to one of the two groups, Blinding description: To blind the study, the drugs will be prepared by the operating room technician before the intervention. In terms of the amount of the drug, all drugs will be reached the same volume using distilled water. These syringes will be coded and placed in the operating room and delivered daily to the researcher, who will prescribe them without knowing the type of medication. Also, the patient, the person recording the clinical and basic information of the patients as well as the statistical analyst will not be aware of the type of intervention. 3 Mastoidectomy-tympanoplasty Surgery. Intervention 1: Intervention group: In this group, 0.15 mg/kg morphine (Daru Pakhsh Company) and 10 mg triamcinolone (Germany Hexal Company) to 100 mg lidocaine 2% (Aburaihan Tehran) and epinephrine with a concentration of 1 to 100,000 (Daru Pakhsh Company) is added and injected topically by the surgeon at the surgical incision site before surgery. Intervention 2: Control group: In this group, according to the usual method, 0.15 mg/kg morphine (Daru Pakhsh Company) is injected intravenously before surgery. Then, 100 mg of lidocaine 2% (Aburaihan Company) and epinephrine with a concentration of 1 to 100,000 (Daru Pakhsh Company) are injected topically at the surgical incision site before surgery. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Reihanak Talakoub
Anesthesiology Department, Al-Zahra Hospita, Sefeh Blvd., Tohid Street
Isahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 Talakoub@med.mui.ac.ir Esfahan University of Medical Sciences scientific Reihanak Talakoub
Anesthesiology Department, Al-Zahra Hospita, Sefeh Blvd., Tohid Street
Isahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 Talakoub@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Age 15 to 65 years Indicated for mastoidectomy-tympanoplasty Satisfaction to participate in the study 15 years 65 years Both Having a history of drug and alcohol addiction Having a history of seizures and mental health problems Having kidney disease Death of the patient Treatment - Drugs N/A Intervention group: In this group, 0.15 mg/kg morphine (Daru Pakhsh Company) and 10 mg triamcinolone (Germany Hexal Company) to 100 mg lidocaine 2% (Aburaihan Tehran) and epinephrine with a concentration of 1 to 100,000 (Daru Pakhsh Company) is added and injected topically by the surgeon at the surgical incision site before surgery. Control group: In this group, according to the usual method, 0.15 mg/kg morphine (Daru Pakhsh Company) is injected intravenously before surgery. Then, 100 mg of lidocaine 2% (Aburaihan Company) and epinephrine with a concentration of 1 to 100,000 (Daru Pakhsh Company) are injected topically at the surgical incision site before surgery. Pain score. Timepoint: Immediately upon entering the recovery and at 2, 8, 12 and 24 hours after surgery. Method of measurement: Visual Analogue Scale. Systolic blood pressure. Timepoint: Before induction of anesthesia, immediately after induction of anesthesia and every ten minutes during surgery until the end of surgery. Method of measurement: Monitoring device. Diastolic blood pressure. Timepoint: Before induction of anesthesia, immediately after induction of anesthesia and every ten minutes during surgery until the end of surgery. Method of measurement: Monitoring device. Isfahan University of Medical Sciences Approved 2021-04-25 Ethics committee of Isfahan University of Medical Sciences Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq Isfahan Isfehan Iran (Islamic Republic of)