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IRCT20220501054713N1 IRCT 2022-05-22 Oroumia University of Medical Sciences Evaluation of effect of the local infltration of bupivacain with or without dexamethasone on severity of acute pain in women undergoing cesarian section Evaluation of effect of the local infltration of bupivacain with or without dexamethasone on severity of acute pain in women undergoing cesarian section 2022-05-22 anticipated 75 Complete https://irct.ir/trial/63347 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 75 pregnant women who are candidates for elective cesarean section will be examined by Fanstyle incision, which will be divided into three groups of 25 people using a random number table taken from www.graphpad, Blinding description: Patient groups will be coded and this coding will be blurred for researchers, patients and outcome assessors and data analysts and clinicians, and only patient names will be kept in a package after grouping and coding. And the appearance of the drugs and placebo will be chosen quite similar to each other. 3 Pain from cesarean section. Intervention 1: Intervention group: Intervention group 1: The first procedure will inject 0.5 cc of marcaine 0.5% plus 10 cc of normal saline into the fascia and subcutaneous muscle. Intervention 2: Intervention group: The second group of 10 cc of marcaine 0.5% plus 8 cc of normal saline with 2 cc of dexamethasone ampoule will be injected into the fascia and subcutaneous muscle. Intervention 3: Control group: 8 cc of normal saline will be injected into the fascia and subcutaneous muscle. Yes - There is a plan to make this available What will be shared: The data file and encrypted information will be shared via personal email without the patients's name, if there is a reasonable request from the researchers. When: Access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: For systematic review studies or meta-analysis Where to obtain: Send email to Dr. Haleh Ayatollahi with the address hayatollahi@yahoo.com How to obtain: By sending an email and a detailed explanation of the reason for the request and the requested items Comments:
public Haleh Ayatollahi
G3QJ+GPV, Urmia, West Azerbaijan Province
Urmia Iran (Islamic Republic of) 5714783734 +98 44 3223 4897 hayatollahi@yahoo.com Oroumia University of Medical Sciences scientific Haleh Ayatollahi
G3QJ+GPV, Urmia, West Azerbaijan Province
Urmia Iran (Islamic Republic of) 5714783734 +98 44 3223 4897 hayatollahi@yahoo.com Oroumia University of Medical Sciences Iran (Islamic Republic of) 1- Pregnant women in the age range of 18 to 40 years 2- Women who are in ASA1 and ASA2 groups according to ASA (American Society of Anesthesiologists) in terms of physical condition. 18 years 40 years Female Long surgery longer than two hours History of allergy to local anesthetics History of cesarean section more than twice History of drug abuse History of fibromyalgia or chronic nerve pain BMI above 35 Change the type of surgery. R10.2 Pelvic and perineal pain Treatment - Drugs Treatment - Drugs Placebo Intervention group: Intervention group 1: The first procedure will inject 0.5 cc of marcaine 0.5% plus 10 cc of normal saline into the fascia and subcutaneous muscle. Intervention group: The second group of 10 cc of marcaine 0.5% plus 8 cc of normal saline with 2 cc of dexamethasone ampoule will be injected into the fascia and subcutaneous muscle. Control group: 8 cc of normal saline will be injected into the fascia and subcutaneous muscle. Visual Analogue Scale Score after cesarean section. Timepoint: VAS score after cesarean section at zero hours of recovery and one hour after surgery. Method of measurement: Visual Analogue Scale. Dosage of the drug in the first 24 hours after cesarean section. Timepoint: the first 24 hours after cesarean section. Method of measurement: Total dose of drugs used per mg/dl. Oroumia University of Medical Sciences Approved 2022-04-20 Ethics committee of Urmia University of Medical Sciences G3QJ+GPV, Urmia, West Azerbaijan Province Urmia West Azarbaijan Iran (Islamic Republic of)