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IRCT20210405050851N1 IRCT 2021-10-30 Iran University of Medical Sciences Comparing of programmed intermittent epidural bolus with continuous epidural infusion for labor analgesia Comparing of programmed intermittent epidural bolus (PIEB) with continuous epidural infusion (CEI) for labor analgesia in patients receiving epidural dexmedetomidine and Rupivacaine 2021-11-06 anticipated 60 Complete https://irct.ir/trial/57447 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly assigned to tree groups by using a random number table. In order to randomize, a random block method will be used. For this purpose, we formed blocks of size 6. In each block, 3 individuals will be in first intervention group and 3 will be in second intervention group. A total of 10 blocks will be considered for the study, Blinding description: Surgeons and patients will be kept blind and unaware of the type of labor analgesia . Patients will be aware that they will be randomly assigned to one of two treatment groups, but will be unaware of which analgesic method will be provided in that group. Patients will be assigned to one of two groups using random number tables. The surgeon also knows that patients will be anesthetized in two different ways, but will not know which procedure will be performed for each patient. The data collection officer, analyst and outcome assessor will collect and analyze information based on groups 1 and 2 and will not be aware of the type of type of analgesia presented in the groups. They will be kept blind. 2-3 Epidural labor analgesia. Intervention 1: Intervention group 1: Term women with gestational age 37 weeks or more who have entrance condition to the study, amount of 3cc test dose of Dexmedetomidine 0.5µg/ml and Rupivacain %0.1 will be administered and after 5 minutes, amount of 8cc from the same solution as loading dose will be administered. then in the group programmed intermittent epidural bolus, bolus dose of 8cc of the solution will be administered every 60 minutes regularly. Intervention 2: Intervention group 2: Term women with gestational age 37 weeks or more who have entrance condition to the study, amount of 3cc test dose of Dexmedetomidine 0.5µg/ml and Rupivacain %0.1 will be administered and after 5 minutes, amount of 8cc from the same solution as loading dose will be administered. in the continuous epidural infusion group, infusion of 8 cc/hr of the solution consumption as maintenance after loading dose will be administered continuously by an infusion pomp. 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 After completing the work and consulting with all the writers and executive agents, I will be decided.
public Golnoosh Khosravian
No. 2, Dead end Aghaghia., South Makouyipour Ave., Behzadi Ave.,13th East Velenjak Ave
Tehran Iran (Islamic Republic of) 1987733373 +98 21 2243 4717 desdemona_wsh@yahoo.com Iran University of Medical Sciences scientific Golnoosh Khosravian
No. 2, Dead end Aghaghia., South Makouyi pour Ave., Behzadi Ave., 13thEast Velenjak Ave
Tehran Iran (Islamic Republic of) 1987733373 +98 21 2243 4717 desdemona_wsh@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Term woman with gestational age 37 weeks or more Cervical dilation Larger than 4 cm Spontaneous or induced labor pain Applying for epidural analgesia Weight 55 to 85 kg 18 years 45 years Female Patients with past medical history of sever cardiovascular diseases and bradycardia Contraindication of epidural analgesia Patients that are candidate for cesarean section ( multiple pregnancy , gestational age more than 37 weeks, preeclampsia , etc ) Patient discontent Opium addiction Height less than 150 cm O74.6 Other complications of spinal and epidural anesthesia during labor and delivery Treatment - Drugs Treatment - Drugs Intervention group 1: Term women with gestational age 37 weeks or more who have entrance condition to the study, amount of 3cc test dose of Dexmedetomidine 0.5µg/ml and Rupivacain %0.1 will be administered and after 5 minutes, amount of 8cc from the same solution as loading dose will be administered. then in the group programmed intermittent epidural bolus, bolus dose of 8cc of the solution will be administered every 60 minutes regularly. Intervention group 2: Term women with gestational age 37 weeks or more who have entrance condition to the study, amount of 3cc test dose of Dexmedetomidine 0.5µg/ml and Rupivacain %0.1 will be administered and after 5 minutes, amount of 8cc from the same solution as loading dose will be administered. in the continuous epidural infusion group, infusion of 8 cc/hr of the solution consumption as maintenance after loading dose will be administered continuously by an infusion pomp. Maternal satisfaction of labor analgesia. Timepoint: At the end of labor. Method of measurement: Visual analogue scale. Total dose of Dexmedetomidine using in the end of labor. Timepoint: At the end of labor. Method of measurement: Based on checklist - in milliliters. Total dose of Rupivacain using in the end of labor. Timepoint: At the end of labor. Method of measurement: Based on checklist - in milliliters. New born Infant Apgar score. Timepoint: In the first and fifth minute after fetal delivery. Method of measurement: Apgar score. Infant Arterial Blood Gas. Timepoint: Five minutes after fetal delivery. Method of measurement: Umbilical cord arterial blood. Incidence rate of instrumental delivery. Timepoint: The last stage of delivery. Method of measurement: Record in the end of labor. Duration of delivery. Timepoint: Duration of delivery from the time of patient entrance in the labor until the time of fetal delivery. Method of measurement: Based on checklist - minute unit. Side effects including nausea, vomiting, itching, decrease blood pressure, bradycardia. Timepoint: From the loading dose of epidural analgesia every hour till the end of labor. Method of measurement: Patient's sign and symptoms and record in the checklist. Incidence rate of motor block. Timepoint: From the beginning of Epidural analgesia every hour till the end of labor. Method of measurement: Bromage score (0- 1- 2- 3). Iran University of Medical Sciences Approved 2020-09-19 Ethics committee of Iran University of Medical Science Iran University of Medical Sciences, Hemmat Highway Tehran Tehran Iran (Islamic Republic of)