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IRCT20230310057671N1 IRCT 2023-04-16 Karaj University of Medical Sciences Comparison of the clinical results of the use of two spinal epidural methods and epidural puncture epidural in the process of natural childbirth analgesia Comparison of DPE and CSE Comparison of the clinical results of the use of two spinal epidural methods and epidural puncture epidural in the process of natural childbirth analgesia - a randomized clinical trial 2023-05-30 anticipated 98 Complete https://irct.ir/trial/69568 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: According to the formula of the sample size and after applying the entry and exit criteria, 98 people will enter the study in two groups and will be divided by random block allocation method using randomization software. They will be selected using blocks of four. Code A is the intervention group (using the DPE method) and code B is the comparison group (using the CSE method). We will have 6 quadruple combinations as (AA,BB),(AB,BA),(BA,BA),(AB,AB),(BB,AA), and (BA,AB). Then for each of these Random code blocks will be generated. 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. This random process of selecting blocks and assigning people to intervention and comparison groups It will continue until the desired sample size is reached, Blinding description: This study is designed in a double-blind manner, thus the surgeon is aware of the status of assigning people to the study groups, but the data collector and analyst as well as the subjects (patients) are not aware of the status of assigning people to the study groups. For the study subjects, before the random assignment, 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 beforehand, so the patient is not aware that in Which group is placed will be unknown (written consent will be obtained from all participants in the study). On the other hand, the data collector and analyzer will be unaware of the patients' belonging to the treatment groups. N/A Pregnant women giving birth naturally. Intervention 1: Control group: In a group, combined spinal epidural analgesia (CSE) is performed in the following way: CSE is performed in stage I, in the first step, spinal analgesia is performed, in such a way that after prep and drape, spinal needle 25-28 in the L4-L5 intervertebral space, it enters the skin, passes through the dura mater and goes to the sub-arachnoid and enters the CSF space, after the CSF exit, the medicine will be injected within 3-5 seconds. Spinal Opiod: Fentanyl (dose: 15-25 micrograms) or sufentanil (dose: 10-5 micrograms) in the second step after prep and drape, the Touhy needle will go to the epidural space and a 5 cm catheter will be fixed in the epidural space and then the dose test will be done through Catheter is injected. Medicines: ropivacaine or bupivacaine with a concentration of 1% (10-20 cc), lidocaine. Intervention 2: Intervention group: In the other group, dural epidural puncture (DPE) is performed in the following way: DPE is also performed in stage I, it is performed like the first spinal CSE, only with the difference that no drug is injected and the goal is only to puncture the dura. and then an epidural is performed and the catheter is fixed, here too no medication is administered until the mother enters the active phase of labor and her pain starts, then through the catheter first fentanyl (dose 15-25 micrograms) and then Rs. Vaccaine (10-20 cc) is administered. , and because of the hole created in the dura, the drug enters the CSF, even though he did not take medication during the spinal, but with the start of his epidural drugs, it seems as if the spinal is performed at the same time, in DPE, unlike CSE, not all fentanyl directly enters the CSF and It is gradually absorbed (in general, the drugs are the same in both methods, only the method and time of drug absorption are different, which differentiates the side effects of these two methods) The percentage of drugs in both methods is diluted based on the patient's BMI. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals When: The access period starts one year after the results are published To whom: Researchers working in academic and scientific institutions Conditions: Any kind of scientific or research use Where to obtain: Laden agriculture Receive data via email below ladan.keshavarzi@yahoo.com How to obtain: After receiving the request email, the request will be answered within a maximum of two months. Comments: No other explanation
public Mohammad Hossein Delshad
NO 4, The highly specialized pain clinic of Maryam Hospital, street West Arghwan, 45 meter Golshahr, Alborz province,karaj
Karaj Iran (Islamic Republic of) 123456780 +98 26 3350 2347 info@maryamhospital.ir Karaj University of Medical Sciences scientific Mohammad Hossein Delshad
NO 4, The highly specialized pain clinic of Maryam Hospital, street West Arghwan, 45 meter Golshahr, Alborz province,karaj
Karaj Iran (Islamic Republic of) 3192152365 +98 26 3350 2347 info@maryamhospital.ir Karaj University of Medical Sciences Iran (Islamic Republic of) 37 weeks to 40 weeks pregnant women in normal labor vertex position 18 years 45 years Female Non-vortex position Pregnant women's inability to maintain immobility during work (for example, Parkinson's disease) Coagulation disorders and homeostasis defects Increased intracranial pressure for any reason (space-occupying lesions) Local infection of the injection site and bacteremia Treatment - Surgery Treatment - Surgery Control group: In a group, combined spinal epidural analgesia (CSE) is performed in the following way: CSE is performed in stage I, in the first step, spinal analgesia is performed, in such a way that after prep and drape, spinal needle 25-28 in the L4-L5 intervertebral space, it enters the skin, passes through the dura mater and goes to the sub-arachnoid and enters the CSF space, after the CSF exit, the medicine will be injected within 3-5 seconds. Spinal Opiod: Fentanyl (dose: 15-25 micrograms) or sufentanil (dose: 10-5 micrograms) in the second step after prep and drape, the Touhy needle will go to the epidural space and a 5 cm catheter will be fixed in the epidural space and then the dose test will be done through Catheter is injected. Medicines: ropivacaine or bupivacaine with a concentration of 1% (10-20 cc), lidocaine. Intervention group: In the other group, dural epidural puncture (DPE) is performed in the following way: DPE is also performed in stage I, it is performed like the first spinal CSE, only with the difference that no drug is injected and the goal is only to puncture the dura. and then an epidural is performed and the catheter is fixed, here too no medication is administered until the mother enters the active phase of labor and her pain starts, then through the catheter first fentanyl (dose 15-25 micrograms) and then Rs. Vaccaine (10-20 cc) is administered. , and because of the hole created in the dura, the drug enters the CSF, even though he did not take medication during the spinal, but with the start of his epidural drugs, it seems as if the spinal is performed at the same time, in DPE, unlike CSE, not all fentanyl directly enters the CSF and It is gradually absorbed (in general, the drugs are the same in both methods, only the method and time of drug absorption are different, which differentiates the side effects of these two methods) The percentage of drugs in both methods is diluted based on the patient's BMI. The amount of pain during childbirth is independent. Timepoint: 0-5-10-15-20-30-45-60-90-120 min. Method of measurement: The intensity of the patient's pain during labor is measured by the numerical rating pain scale. Type of delivery (natural without tools / natural with the help of tools (vacuum) / ending in caesarean section). Timepoint: Time of delivery. Method of measurement: Description of the operation by the surgeon. Headache. Timepoint: 0 minutes, 12 hours, 24 hours. Method of measurement: Ask the person ، (After the analgesia intervention, it is only important for us whether the person has a headache at the mentioned times or not, the amount of headache that is low or high is not valuable for us in this study, for this reason, the person is only asked that Does he have a headache or not?. Itching. Timepoint: 0 minutes, 5 minutes, 10 minutes. Method of measurement: Ask the person ، (After the analgesia intervention, it is only important for us if the person itches at the mentioned times or not, the amount of itching that is low or high has no value for us in this study, for this reason, the person is only asked that is it itchy or not). Paresthesia. Timepoint: 0 minutes, 60 minutes, 12 hours, 24 hours. Method of measurement: paresthesia ، (After the analgesia intervention, it is only important for us whether the person experiences paresthesia at the mentioned times or not, the amount of paresthesia that is low or high has no value for us in this study, for this reason, the person is only asked that Does it have paresthesia or not?. Urinary retention. Timepoint: 12 hours, 24 hours. Method of measurement: Ask the person ، (After the analgesia intervention, it is only important for us if the person has urinary retention at the mentioned times or not, the amount of urinary retention that is low or high has no value for us in this study, that is why we only ask the person whether he has urinary retention or not). Bishop Score. Timepoint: 0 min (immediately after the analgesia intervention). Method of measurement: Bishop's score is determined by examining five characteristics: dilatation, effacement, descent, location of the cervix and consistency of the cervix based on the scoring system of the Bishop Score table. The scoring is calculated and recorded by the researcher in the laber. Length of the second stage of labor. Timepoint: Starting from the complete dilatation of the cervix and continuing until the delivery of the baby, the analgesia intervention is performed before the complete dilatation of the cervix. Method of measurement: We take time with the clock. Karaj University of Medical Sciences Approved 2023-04-07 Ethics committee of َAlborz University of Medical Sciences No. 6, Unit 3, No. 6, Alley 9/4, 9th St., Valfajr Town, Tehran, Sheikh Bahai St. Karaj Alborz Iran (Islamic Republic of)