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IRCT20211112053042N4 IRCT 2022-09-29 Karaj University of Medical Sciences The effect of dural epidural puncture technique in comparison with combined epidural-spinal and epidural techniques in painless delivery and the consequences of labor, mother and newborn Evaluation of the effect of dural epidural puncture technique in comparison with combined epidural-spinal and epidural techniques in painless delivery and the consequences of labor, mother and newborn 2022-10-06 anticipated 90 Complete https://irct.ir/trial/66069 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Study subjects will be divided into three groups, epidural , dural epidural puncture and combined epidural-spinal , using a simple randomization method and using a table of random numbers. First, each person is assigned a number. Then, using the table of random numbers, each selected number is randomly assigned to one of the groups, and this work continues until the number of people in each group is completed. Therefore, the researcher will not have the authority to change the status of the assignment of people or to predict it. Randomization concealment will be done by a third person who does not participate in other stages of the intervention. 2-3 Painless delivery. Intervention 1: The first intervention group: Dural epidural puncture group: With the needle-through-needle technique, a Whitacre 25 gage spinal needle is used to confirm dural puncture in the axis of the epidural needle. 8-12 ml of ropivacaine 0.1% is used. Intervention 2: The second intervention group: Epidural anesthesia is performed like the epidural group and spinal anesthesia using Quincke 25 gage needle. 8-12 ml of ropivacaine 0.1% is used. Intervention 3: Control group: Epidural group: The pregnant woman is placed in a sitting position, then in the L2-L3 or L3-L4 regions with a midline approach, with a 17 gage epidural needle the epidural space is determined using loss of resistance to saline. 8-12 ml of ropivacaine 0.1% is used. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified individuals. When: Access period starts 6 months after the results are published. To whom: Research centers and faculty members Conditions: At the request of the researcher and faculty members Where to obtain: Send email to the scientific respondent How to obtain: Within two months from the time of requesting and sending the email, the documents will be sent to the mentioned people Comments:
public Mohammad Hossein Delshad MD.
Arghavan Gharbi, 45 meters from Golshahr Street, Karaj, Alborz Province
Karaj Iran (Islamic Republic of) 3198683639 +98 26 3350 2347 m.delshad@abzums.ac.ir Karaj University of Medical Sciences scientific Mohammad Hossein Delshad MD.
Arghavan Gharbi, 45 meters from Golshahr Street, Karaj, Alborz Province
Karaj Iran (Islamic Republic of) 3198683639 +98 26 3350 2347 m.delshad@abzums.ac.ir Karaj University of Medical Sciences Iran (Islamic Republic of) Pregnant women with ASA Class I, II Gestation age 38-42weeks Singleton Vertex presentation Entering the active phase of labor with dilatation less than 5 cm A candidate for painless delivery Pregnant women with consent to participate in the project 18 years 50 years Female Pregnant women with lack of consent to participate in the project History of back surgery Diseases related to pregnancy such as gestational hypertension, preeclampsia, gestational diabetes Contraindications for performing neuraxial analgesia techniques Known fetal anomaly A condition with an increased risk of cesarean section, such as a history of previous cesarean section, a history of uterine rupture Diseases of the central nervous system Allergy to the drugs used in the study Coagulation disorders, decreased platelet count Local or systemic infection The presence of blood or cerebrospinal fluid in the epidural catheter during the procedure History of drug abuse People who are unable to maintain the position when the needle is inserted History of spine surgery Presence of wound and infection at the needle entry site O80 Encounter for full-term uncomplicated delivery Prevention Prevention Prevention The first intervention group: Dural epidural puncture group: With the needle-through-needle technique, a Whitacre 25 gage spinal needle is used to confirm dural puncture in the axis of the epidural needle. 8-12 ml of ropivacaine 0.1% is used. The second intervention group: Epidural anesthesia is performed like the epidural group and spinal anesthesia using Quincke 25 gage needle. 8-12 ml of ropivacaine 0.1% is used. Control group: Epidural group: The pregnant woman is placed in a sitting position, then in the L2-L3 or L3-L4 regions with a midline approach, with a 17 gage epidural needle the epidural space is determined using loss of resistance to saline. 8-12 ml of ropivacaine 0.1% is used. Pain. Timepoint: Before the start of the procedure, 5, 10, 15, 30, 45, 60, 90, 120, 180, 240 minutes after the procedure, cervical dilatation 6 cm, cervical dilatation 10 cm, immediately after the exit of the fetus. Method of measurement: Visual Analogue Scale. Analgesia onset time. Timepoint: When with the first bolus injection, the pain score is <= 3 based on VAS. Method of measurement: Ask the patient. Movement block. Timepoint: every 15 minutes. Method of measurement: Based on scoring Bromage criteria. Sensory block. Timepoint: every 15 minutes. Method of measurement: Sensory block at S2 and T10 levels. Systolic blood pressure. Timepoint: Before the procedure, 5, 10, 15, 30, 45, 60, 75, 105, 135, 165 minutes later. Method of measurement: Measurement with pressure gauge. Diastolic blood pressure. Timepoint: Before the procedure, 5, 10, 15, 30, 45, 60, 75, 105, 135, 165 minutes later. Method of measurement: Measurement with pressure gauge. Heart rate. Timepoint: Before the procedure, 5, 10, 15, 30, 45, 60, 75, 105, 135, 165 minutes later. Method of measurement: Measurement with non-invasive devices. Oxygen saturation. Timepoint: Before the procedure, 5, 10, 15, 30, 45, 60, 75, 105, 135, 165 minutes later. Method of measurement: Pulse Oximetry. Apgar score. Timepoint: At 1 and 5 minutes after birth. Method of measurement: Neonatal specialist examination. Karaj University of Medical Sciences Approved 2022-09-23 Ethics committee of Alborz University of Medical Sciences second floor, Deputy of Research and Technology, Saffarian Alley, 45 meters from Golshahr, Karaj. Karaj Alborz Iran (Islamic Republic of)