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IRCT20230903059336N1 IRCT 2023-09-22 Karaj University of Medical Sciences Comparison between spinal epidural and Dural puncture epidural in natural childbirth analgesia EP / DPE Comparison between spinal epidural and Dural puncture epidural in natural childbirth analgesia 2023-11-05 anticipated 98 Complete https://irct.ir/trial/72413 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method of random allocation of blocks will be divided using randomization software, blocks of four will be selected, code A will be the intervention group (using the DPE method) and code B will be the comparison group (using the EP method) and we will make six combinations of four. Then random codes will be generated for each of these blocks, then one of these blocks will be randomly selected, and based on the sequence of letters A and B in the selected block, eligible people will be assigned to treatment or comparison groups, Blinding description: The method of block random assignment will be divided using randomization software, using blocks of four, code A will be the intervention group (using the DPE method) and code B will be the comparison group (using the EP method) and we will make six combinations of four. Then random codes will be generated for each of these blocks, then one of these blocks will be randomly selected and based on the sequence of letters A and B in the selected block, the eligible people will be assigned to treatment or comparison groups. This process The random selection of blocks and assigning people to the intervention and comparison groups will continue until the desired sample size is reached. This method solves the problem of imbalance that may occur in simple randomization, so this study is two-sided. It is blind designed, thus the surgeon is aware of the status of assigning people to the study groups, but the data collector and analyzer as well as the patients are not aware of the status of assigning people to the study groups. For the study subjects, before random allocation, it is explained how the work process is, and they may receive one of the two treatments randomly, and the method used is not known to the subjects in advance, therefore, the patient does not know in which The group has been placed will be unaware, on the other hand, the data collectors and analysts will also be unaware of the patients' belonging to the treatment groups. 2-3 Analgesia childbirth. Intervention 1: Code A is the intervention group (using the DPE method) . We will have six quadruple combinations as (AA,BB) (AB,AB) (BA,BA) (AB,BA) (BB,AA) (BA,AB). Then random codes will be generated for each of these blocks, then one of these blocks will be randomly selected and based on the sequence of letters A and B in the selected block, the eligible people will be assigned to treatment or comparison groups. This random process of selecting blocks and assigning people to the intervention and comparison groups will continue until the desired sample size is reached. Local anesthetics include: bupivacaine, levobopivacaine, and ropivacaine. Intervention 2: code B is the comparison group (using the EP method). We will have six quadruple combinations as (AA,BB) (AB,AB) (BA,BA) (AB,BA) (BB,AA) (BA,AB). Then random codes will be generated for each of these blocks, then one of these blocks will be randomly selected and based on the sequence of letters A and B in the selected block, the eligible people will be assigned. Yes - There is a plan to make this available What will be shared: comparison between spinal epidural and dural puncture epidural in natural childbirth analgesia When: after childbirth analgesia To whom: Student Conditions: Evaluation and comparison of the results of two groups Where to obtain: kamali hospital How to obtain: performing analgesia then following up the patients in terms of complications and other variables and finally analyzing data Comments:
public Mohammad Hossein Delshad
No6 9tha Avenue Valfajr Street South Sheikh Bahai
Tehran Iran (Islamic Republic of) 1437835174 +98 21 8803 5138 minasalehi74@yahoo.com Karaj University of Medical Sciences scientific Mohammad Hossein Delshad
No6 9th Avenue Valfajr Street South Sheikh Bahai
Tehran Iran (Islamic Republic of) 1437835174 +98 21 8803 5138 minasalehi74@yahoo.com Karaj University of Medical Sciences Iran (Islamic Republic of) pregnant women 37 to 40 weeks women in the active stage of childbirth vortex position no limit no limit Female Non-vortex position Increased intracranial pressure Bacteremia Local infection at the injection site Dissatisfaction of the pregnant women malignancy Cardiac heart failure Uncontrolled diabetes mellitus Coagulation disorder Anatomical deformity of the spine Treatment - Drugs Treatment - Drugs Code A is the intervention group (using the DPE method) . We will have six quadruple combinations as (AA,BB) (AB,AB) (BA,BA) (AB,BA) (BB,AA) (BA,AB). Then random codes will be generated for each of these blocks, then one of these blocks will be randomly selected and based on the sequence of letters A and B in the selected block, the eligible people will be assigned to treatment or comparison groups. This random process of selecting blocks and assigning people to the intervention and comparison groups will continue until the desired sample size is reached. Local anesthetics include: bupivacaine, levobopivacaine, and ropivacaine code B is the comparison group (using the EP method). We will have six quadruple combinations as (AA,BB) (AB,AB) (BA,BA) (AB,BA) (BB,AA) (BA,AB). Then random codes will be generated for each of these blocks, then one of these blocks will be randomly selected and based on the sequence of letters A and B in the selected block, the eligible people will be assigned Pain score. Timepoint: minutes of 0 5 10 15 20 30 45 60 90 120. Method of measurement: Asking person. Dyspnea. Timepoint: Immediately after birth. Method of measurement: counting. Seizure. Timepoint: Immediately after birth. Method of measurement: Clinical symptoms. Hypotention. Timepoint: Immediately after birth. Method of measurement: Manitor. Meningitis. Timepoint: Immediately after birth. Method of measurement: Clinical symptom. Karaj University of Medical Sciences Approved 2023-08-27 Ethics Committee of Alborz University of Medical Sciences No6, 9th Avenue Valfajr Street South Sheikh Bahai Tehran Tehran Iran (Islamic Republic of)