Authors
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[No authors listed]
Category
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Primary study
Registry of Trials»Iranian Registry of Clinical Trials
Year
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2023
INTERVENTION: 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 method CONDITION: Pregnant women giving birth naturally. INCLUSION CRITERIA: 37 weeks to 40 weeks pregnant women in normal labor verte Xposition PRIMARY OUTCOME: 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. 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). 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. 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?. 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. 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).
Epistemonikos ID: 2f26e9ff98a80406e58e188e0588841031e2ba17
First added on: Feb 20, 2024