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IRCT20190123042473N1 IRCT 2021-02-28 Birjand University of Medical Sciences The effect of magnesium sulfate on post-cesarean pain control The effect of adding magnesium sulfate to Marcaine intrathecal in controlling pain after cesarean section 2018-02-05 anticipated 42 Complete https://irct.ir/trial/37182 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Lottery method; Eligible individuals were randomly assigned to one of the two groups of Marcaine intrathecal or magnesium sulfate recipients along with Marcaine intrathecal. The method of drawing was to place balls in container that the number of 1 to 9 was written inside the balls. For each patient who entered the study, a ball went out of the container accidentally. If the it was an odd number, that patient would be assigned to the Marcaine intrathecal group, and if it was even , the individual would be assigned to the magnesium sulfate receiving group, along with Marcaine intrathecal, Blinding description: In this study, two drugs of Marcaine intrathecal and magnesium sulfate recipients along with Marcaine intrathecal were prepared by a pharmacist with similar shape, color, smell, and size and placed in coded packages, and provided to the researcher. He/She prescribes them without knowing the type of each drug. Also, the person recording the patient's clinical information and the statistical analyst will not be aware of the type of intervention. 3 cesarean section. Intervention 1: Intervention group: receives 10 mg of marcaine 0.5% (CobelDarou, Tehran) and 80 mg of magnesium sulfate (CobelDarou, Tehran) , intrathecally (in the third, fourth or fourth and fifth space between the vertebrae) before surgery. The severity of pain will be recorded using the VAS score and by asking the patient at 1, 2, 3, 4, and 8 hours after surgery. Intervention 2: Control group: Patients in the control group receive only 10 mg of marcaine 0.5% (CobelDarou, Tehran) intrathecally (in the third, fourth or fourth and fifth space between the vertebrae). The severity of pain will be recorded using the VAS and asking the patient at 1, 2, 3, 4, and 8 hours after surgery. 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 No more information
public Seyed Mohammad Ebnehejazi
Birjand University of Medical Sciences , Ghafari Street, Birjand, Southern Khorasan`
Birjand Iran (Islamic Republic of) ۹۷۱۷۸۵۳۵۷۷ +98 56 3238 1200 ebnehejazi49@yahoo.com Birjand University of Medical Sciences scientific Seyed Mohammad Ebnehejazi
Birjand University of Medical Sciences , Ghafari Street, Birjand, Southern Khorasan
Birjand Iran (Islamic Republic of) 9717853577 +98 56 3238 1200 ebnehejazi49@yahoo.com Birjand University of Medical Sciences Iran (Islamic Republic of) Women without history of bleeding after surgery. Women without allergy to Amide anesthetics. Women without history of heart, liver and renal diseases. Women without history of taking psychedelic drugs. The women with the age of 15 - 45 years. The women without history of smoking. The women without history of coagulation diseases. The women without history of infectious diseases. 15 years 45 years Female Having neuro-muscular disease Use of opioids or painkillers during 3 days before the study Severe obesity (BMI ≥ 35-34) Consumption of calcium channel blockers O75.9 Complication of labor and delivery Treatment - Drugs Treatment - Drugs Intervention group: receives 10 mg of marcaine 0.5% (CobelDarou, Tehran) and 80 mg of magnesium sulfate (CobelDarou, Tehran) , intrathecally (in the third, fourth or fourth and fifth space between the vertebrae) before surgery. The severity of pain will be recorded using the VAS score and by asking the patient at 1, 2, 3, 4, and 8 hours after surgery. Control group: Patients in the control group receive only 10 mg of marcaine 0.5% (CobelDarou, Tehran) intrathecally (in the third, fourth or fourth and fifth space between the vertebrae). The severity of pain will be recorded using the VAS and asking the patient at 1, 2, 3, 4, and 8 hours after surgery. Pain. Timepoint: at 1, 2, 3, 4, 8, 12 postoperative hours. Method of measurement: Verbal Analogue Scale method. Blood pressure. Timepoint: at 1, 2, 3, 4, 8, 12 postoperative hours. Method of measurement: Mercury sphygmomanometer. Hear rate. Timepoint: at 1, 2, 3, 4, 8, 12 postoperative hours. Method of measurement: heart-rate monitors. Birjand University of Medical Sciences Approved 2018-02-11 Ethics committee of Birjand University of Medical Sciences Birjand University of Medical sciences, Ghafari Ave Birjand South Khorasan Iran (Islamic Republic of)