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IRCT20231204060259N1 IRCT 2024-01-01 Islamic Azad University Investigating the effect of adding pethidine to Marcaine on postoperative pain Investigating the effect of adding pethidine to Marcaine on the Score of postoperative pain with spinal anesthesia in candidates for abdominal surgery 2023-12-03 anticipated 58 Complete https://irct.ir/trial/74155 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization is done in the simple method (randomization based on a single sequence of random assignments). The randomization unit is individual. The randomization tool is an online random number table, so that from right to left, even numbers are considered for the intervention group and odd numbers are considered for the control group. To perform allocation concealment, each of the generated random sequences is written on a card, and the cards are placed in opaque, sealed and completely identical envelopes in order. To maintain the random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lids of the envelopes are glued and placed in a box respectively. At the time of registration of the participants, based on the order of entry of the eligible participants into the study, one of the envelopes will be opened and the assigned group of that participant will be revealed. Patients are divided into two groups, 29 samples in each group and a total of 58 samples are included in the study, Blinding description: The drugs (which in the intervention group include marcaine and pethidine and in the control group only include marcaine) are drawn and combined in the spinal syringe before the surgery so that neither the patient nor the surgeon knows about the drug used in the spinal. Then, after the patients enter the operating room, all the patients in the same conditions in 2 groups get spinal anesthesia with a 26 needle. 3 pain score. Intervention 1: Intervention group: 25 mg of pethidine (Aburaihan ‌pharmaceutical Co) is added to marcaine (Pharmed company) in the amount of 3 cc. Intervention 2: Control group: Only Marcaine (Pharmed company) is injected in the amount of 3cc. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Sina Moghadasian Naeini
No. 8, Soheil Alley, Kazemi St., West 7th St., Ajoudaniye St.
Tehran Iran (Islamic Republic of) 1956684699 +98 21 2611 4689 sinamoghadasian@yahoo.com Islamic Azad University scientific Sina Moghadasian Naeini
No. 8, Soheil Alley., Kazemi Ave., Ajoudanie Blvd
Tehran Iran (Islamic Republic of) 1956684699 +98 21 2611 4689 sinamoghadasian@yahoo.com Islamic Azad University Iran (Islamic Republic of) Electiveness of surgery ASA1,2 Age 18-65 years Signing a personal consent form to enter the study No use of drugs and alcohol 18 years 65 years Both Emergency patients Anesthesia class above 3 History of allergy to marcaine and pethidine drugs Rehabilitation Rehabilitation Intervention group: 25 mg of pethidine (Aburaihan ‌pharmaceutical Co) is added to marcaine (Pharmed company) in the amount of 3 cc. Control group: Only Marcaine (Pharmed company) is injected in the amount of 3cc. Postoperative pain score. Timepoint: Measurement of pain score in recovery, 6, 12, 24 hours in two intervention and control groups. Method of measurement: Visual Analogue Scale. Islamic Azad University Approved 2023-11-27 The research ethics committee of medical school - Islamic Azad University of Medical Sciences, Tehra 13th floor, Block A, Treatment and Medical Education, Central Headquarters of the Ministry of Health, Simai Iran Street, between South Flamek and Zarafshan, Quds town (West) Tehran Tehran Iran (Islamic Republic of)