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IRCT20210110049996N1 IRCT 2021-03-05 Qazvin University of Medical Sciences The effect of dexamethasone on reducing pain after cesarean section in pregnant women referred to Kosar Hospital in Qazvin 1399 Investigation of the effect of the intraoperative dose of intravenous dexamethasone on post-cesarean delivery analgesia in pregnant mothers referred to Kosar Educational and Medical Hospital in Qazvin 1399 2021-03-06 anticipated 88 Complete https://irct.ir/trial/53694 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: The method of allocation randomization will be Simple Randomization and using a table of random numbers. So that with equal allocation of 1: 1 ratio, they will be in one of the two groups. To select a personal sample from a table of random numbers, start surprisingly from a table point in the direction of the levels or columns. Selecting a point can be done by closing your eyes and placing your finger or the tip of a Roman pen on the table. Moving in the direction of the row or column is symbolically different. But according to the type of code (two digits) in the direction of the row or column, the same number of digits should be selected. After this, the route numbers are controlled. There will be two types of numbers, one of which is smaller than the additional number of the study population and the other is larger than the number of the population. You just have to choose the numbers. The selected number is in fact the individual code of the sample community that is selected as the sample of the selected group. This work is going on so long that the number of sample people in Group A can be 44. After completing the sample size, the experimental sample work is completed. And the selected numbers are in group B. In this way, the number of people is usually equal and randomly divided into two groups of 44 people, Blinding description: Group assignments will be concealed in opaque sequentially-numbered envelops. After obtaining informed written consent before the operation, the anesthesiologist who will be a part of the research team will open the group assignment. The anesthetist will prescribe the drugs in the same serum as the "study drug." Researcher and patients will not be aware of the drug or placebo injection (Two groups blinded). 3 The effect of intravenous dexamethasone injection on pain after cesarean section. Intervention 1: Control group: Patients in the intervention group will receive IV dexamethasone 8 mg (2 mL) after clamping the umbilical cord. Intervention 2: Control group: After clamping the umbilical cord, patients in the control group will receive IV normal saline 2 mL. Yes - There is a plan to make this available What will be shared: Information on pain relief, analgesia, nausea and vomiting, pruritus, headache, and infection at the incision site after dexamethasone injection is shared without specifying the patient personal information. When: 2022 march To whom: It will be available only to researchers working in academic and scientific institutions Conditions: People in the field of medicine and paramedical Where to obtain: Dr Dadashaliha Kosar Hospital m.dadashaliha@qums.ac.ir Seyedeh Firouzeh Aghanejad Kosar Hospital f.aghanejad@qums.ac.ir How to obtain: If there is any request through email or hospital visiting in-person, it will be answered in 10 days. Comments:
public Seyedeh Firouzeh Aghanejad
Kowsar Hospital, Kowsar Ave, Next to the Electricity Office, Taleqani Ave, Qazvin
Qazvin Iran (Islamic Republic of) 3415613176 +98 28 3323 6374 f.aghanejad@qums.ac.ir Qazvin University of Medical Sciences scientific Seyedeh Firouzeh Aghanejad
Kowsar Hospital, Kowsar Ave, Next to the Electricity Office, Taleqani Ave, Qazvin
Qazvin Iran (Islamic Republic of) 3415613176 +98 28 3323 6374 f.aghanejad@qums.ac.ir Qazvin University of Medical Sciences Iran (Islamic Republic of) Gestational age> = 37 weeks Age over 18 years and no history of specific disease Uncomplicated pregnancy Elective cesarean section (breech, meconium, macrosome, ripit 2) Absence of previous laparotomy incision except cesarean section 18 years no limit Female contraindications to spinal anesthesia allergy to study medications uncontrolled hypertension uncontrolled diabetes mellitus glaucoma IV drug abuse , chronic pain or long-term opioid use steroid medication within the week prior to cesarean delivery subjects with psychiatric illness that would prohibit informed consent or comprehension of the study questions repeat 3 cesarean section or more than two laparotomies chorioamnionitis Intra-abdominal adhesions Treatment - Drugs Placebo Control group: Patients in the intervention group will receive IV dexamethasone 8 mg (2 mL) after clamping the umbilical cord. Control group: After clamping the umbilical cord, patients in the control group will receive IV normal saline 2 mL. The effect of intravenous dexamethasone on pain after cesarean section. Timepoint: 6,12,18,24 hour after surgery. Method of measurement: Both baseline preoperative and postoperative pain scores at rest and movement will be assessed using a numerical rating scale (NRS) ( 0 means “no pain” and 10 means “the worst possible pain”). Pain at rest will be assessed with the patient lying supine and pain with movement will be assessed when moving from the supine to an upright sitting position. Nausea. Timepoint: 6,12,18,24 hour after surgery. Method of measurement: Patients will be asked to rate the severity of postoperative nausea using an 11-point numerical rating scale (NRS) from 0 to 10 (0: “no nausea” to 10: “worst nausea possible”). The number of vomiting episodes, if any during the 24-h study period, will be documented. Pruritus. Timepoint: 6,12,18,24 hour after surgery. Method of measurement: Pruritus will be assessed using an 11-point NRS (0: “no pruritus” to 10: “worst pruritus possible”). Headache. Timepoint: 6,12,18,24 hour after surgery. Method of measurement: Patients will be asked to rate the severity of postoperative headache using an 11-point numerical rating scale (NRS) from 0 to 10 (0: “no headache” to 10: “worst headache possible”). The number of headache episodes, if any during the 24-h study period, will be documented. Qazvin University of Medical Sciences Approved 2020-09-30 Ethics committee of Qazvin University of Medical Sciences Kowsar hospital, Kowsar Ave, Next to the Electricity Office, Taleqani Ave, Qazvin Qazvin Qazvin Iran (Islamic Republic of)