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IRCT20090525001946N11 IRCT 2024-01-02 Rasht University of Medical Sciences The effects of magnesium sulfate in controlling pain and headache in cesarean section Investigating the effects of magnesium sulfate compared to placebo in controlling pain during the first 24 hours after cesarean delivery with spinal anesthesia in pregnant women, a double-blind study 2024-01-05 anticipated 118 Complete https://irct.ir/trial/73867 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Blocked randomization method will be used. Patients are classified into two equal groups: magnesium (M) and placebo (p). For this reason, quadruple blocks will be used, which create six states: (1)MPPM. (2)MPMP. (3)MMPP. (4)PMMP. (5) PMPM. (6)PPMM . We create random integers between 0 and 60 with the help of a computer. For numbers between 0-10, we assign the first combination, for numbers 11-20, the second combination and, Blinding description: Patients will not know which group they are assigned to. The drug will be placed in the same vials in both groups. The allocation envelope will be provided to an anesthesiologist and They are requested to prepare the drugs according to the listed group and provide them to the second anesthesiologist who will be present during the surgery. None of the people present in the operating room, including gynecologists, anesthesiologists, gynecological assistants, and nurses, will know how to allocate people. 3 low and prophylactic doses magnesium sulfate on pain control. Intervention 1: Intervention group: 50 mg/kg of magnesium sulfate in 100 ml of isotonic normal saline solution produced by Pasteur Institute factory and the Iran Injection and Pharmaceutical Products Company will be given intravenously as a preventive dose, once, 15 minutes before the induction of spinal anesthesia. Intervention 2: Control group: they will receive 100 ml isotonic normal saline solution produced by the Iran Injection and Pharmaceutical Products Company, intravenously, as a preventive dose, once 15 minutes before the induction of spinal anesthesia. 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 still planning to share and publish
public Sedighe Bab Eghbal
Al-Zahra Hospital, Namjoo Ave.
Rasht Iran (Islamic Republic of) 54839 -41446 +98 13 3336 9224 Sedigheh.eghbal@yahoo.com Rasht University of Medical Sciences scientific Mandana Mansour Ghanaie
Al-Zahra Hospital, Namjoo Ave.
Rasht Iran (Islamic Republic of) 54839- 41446 +98 13 3336 9224 m_m_ghanaie@yahoo.com Rasht University of Medical Sciences Iran (Islamic Republic of) Cesarean section with spinal anesthesia Placement in class II of anesthesia Being nuli para Acceptable candidate for caesarean section 9 years 45 years Female Magnesium intake 24 hours before surgery History of any surgery Suffering from kidney dysfunction Suffering from heart dysfunction Suffering from Lung dysfunction Suffering from Liver dysfunction Suffering from Myopathy dysfunction Suffering from neuropathy dysfunction Occurrence of severe preeclampsia symptoms Occurrence of eclampsia symptoms Having contraindications for spinal injection such as injection site infection Having contraindications for spinal injection such as coagulation disorders Severe obesity (BMI>30) Treatment with calcium receptor blocking drugs Drug addiction History of long-term use of steroids Allergy to magnesium Multiple pregnancy 060-075 Complications of labour and delivery Prevention Placebo Intervention group: 50 mg/kg of magnesium sulfate in 100 ml of isotonic normal saline solution produced by Pasteur Institute factory and the Iran Injection and Pharmaceutical Products Company will be given intravenously as a preventive dose, once, 15 minutes before the induction of spinal anesthesia. Control group: they will receive 100 ml isotonic normal saline solution produced by the Iran Injection and Pharmaceutical Products Company, intravenously, as a preventive dose, once 15 minutes before the induction of spinal anesthesia. Amount of pain in the abdominal surgery area. Timepoint: In the first 6, 12, 18, and 24 hours. Method of measurement: Pain with scores between zero and ten using a Numeric Pain Rating Scale. Amount of headache. Timepoint: At 6, 12, 18, and 24 hours on the first day and at 12 o'clock on the second and third day after the operation. Method of measurement: Using the headache scoring scale (Visual Analog Scale) with scores between 0 and 10. The amount of painkillers used. Timepoint: In the first 6, 12, 18, and 24 hours. Method of measurement: If the postoperative VAS, NRS score is greater than three. Sensory block. Timepoint: 30 seconds before the skin incision and then from the time the skin incision is made until the end of the surgery, every five minutes until the end of the sensory block.​. Method of measurement: Using a short needle (pin prick test) for sensory block. Motor block. Timepoint: 30 seconds before the skin incision and then from the time the skin incision is made until the end of the surgery, every five minutes until the end of the sensory block. Method of measurement: Evaluation of motor block based on three questions of modified Bromage scale. Guilan University of Medical Sciences Approved 2022-11-09 Research Ethics Committees of Guilan University of Medical Sciences Al-Zahra Hospital, Namjoo Ave. Rasht Guilan Iran (Islamic Republic of)