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IRCT20101211005362N26 IRCT 2021-07-07 Esfahan University of Medical Sciences Effect of local Hydrocortisone on pain and nausea and vomiting after surgery Comparative study of the effect of local infiltration of two doses of Hydrocortisone on pain and nausea and vomiting after laparoscopic cholecystectomy 2021-04-21 anticipated 105 Complete https://irct.ir/trial/54278 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method of randomization in this study is a simple random method using random allocation software, which is an individual randomization unit and random sequencing is done using this software and based on the arrangement presented by patients. Drugs and placebo in syringes together The shape and volume of the preparation are coded depending on the content (1,2,3) and according to the sequence determined by the software, patients receive the desired material. For allocation concealment, the sequentially numbered ,sealed ,opaque envelopes or SNOSE method is used, Blinding description: In this three-blind study of patients and researchers and statistical analysts, the results of the study group and the drug used are not known. Medications are coded. The doctor who injects the medicine only knows the type of medicine, and the information from the study is collected by another doctor who does not know the type of medicine. 3 Condition 1: Post operative pain. Condition 2: Post operative nausea and vomiting. Intervention 1: Intervention group 1: consists of 35 people receiving 100 mg of hydrocortisone who receive the drug once and as a preemptive by local infiltration at the site of laparoscopic cholecystectomy 15 minutes before the surgical incision is made. Intervention 2: Intervention group 2: consists of 35 people receiving 50 mg of hydrocortisone who receive the drug once and as a preemptive by local infiltration at the site of laparoscopic cholecystectomy 15 minutes before the surgical incision is made. Intervention 3: Control group: consists of 35 people receiving 20cc of non-drug normal saline (placebo)which is received as a preemptive by local infiltration at the surgical site of laparoscopic cholecystectomy15 minutes before the surgical incision is made. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Dr. Mohammadreza Safavi
Al-Zahra Educational and Medical Center, Soffe Boulevard , Isfahan
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 1992 safavi@med.mui.ac.ir Esfahan University of Medical Sciences scientific Dr. Mohammadreza Safavi
Al-Zahra Educational and Medical Center, Soffe Boulevard , Isfahan
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 1992 safavi@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Age group 85-20 years Case of laparoscopic cholecystectomy due to chronic cholecystitis ASA physical status one and two 20 years 85 years Both Patients with allergies to local anesthetics and drugs, morbid obesity, advanced respiratory diseases, kidney, blood, liver, cardiovascular Chronic drug use, beta or alcohol adrenergic receptor antagonists, and drug addicts pregnant women Mental retardation G89.18 K91.0 Other acute post procedural pain Vomiting following gastrointestinal surgery Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1: consists of 35 people receiving 100 mg of hydrocortisone who receive the drug once and as a preemptive by local infiltration at the site of laparoscopic cholecystectomy 15 minutes before the surgical incision is made. Intervention group 2: consists of 35 people receiving 50 mg of hydrocortisone who receive the drug once and as a preemptive by local infiltration at the site of laparoscopic cholecystectomy 15 minutes before the surgical incision is made. Control group: consists of 35 people receiving 20cc of non-drug normal saline (placebo)which is received as a preemptive by local infiltration at the surgical site of laparoscopic cholecystectomy15 minutes before the surgical incision is made. Pain Visual Analogue Scale score. Timepoint: In recovery every 15 minutes and up to 24 hours after surgery every 6 hours. Method of measurement: Visual Analogue Scale score. Post operative nausea and vomiting Visual Analogue Scale score. Timepoint: In recovery every 15 minutes and up to 24 hours after surgery every 6 hours. Method of measurement: Visual Analogue Scale score. Esfahan University of Medical Sciences Approved 2021-05-11 Ethics committee of Isfahan university of medical sciences Anesthesiology group, Al-Zahra Educational and Medical Center, Soffe Boulevard, Isfahan Isfahan Isfehan Iran (Islamic Republic of)