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IRCT20180626040240N1 IRCT 2018-08-01 Tabriz University of Medical Sciences Comparison of the Maternal Hemodynamic between Epidural Analgesia Delivery and Combined Spinal-Epidural Analgesia Delivery Comparison of the Maternal Hemodynamic between Epidural Analgesia Delivery and Combined Spinal-Epidural Analgesia Delivery 2018-06-15 anticipated 100 Complete https://irct.ir/trial/32242 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Blinding description: The pregnant gives consent to the Analgesia while she is blind to its type. Trained anesthetize technician and an accoucheuse who are blind to the analgesia type monitor and record the maternal hemodynamic. N/A Analgesia for normal vaginal delivery. Intervention 1: Intervention group: Epidural analgesia The neuroaxial block is performed with epidural needle number 18 G . First, for the test dose: 3 ml of lidocaine 1.5%, 50 μg of fentanyl and 2.5 mg of bupivacaine is used. Then as a preservative dose 6 cc / h from this solution is injected through the catheter. Intervention 2: Intervention group: combined spinal-epidural analgesia First with a spinal needle 25G, the spinal block with 1.5ml of the same solution is performed and then the epidural block will be performed using the same method of epidural group. Yes - There is a plan to make this available What will be shared: We will act according to the laws of the Ministry of Health and Medical Education and Tabriz University of Medical Sciences When: We will act according to the laws of the Ministry of Health and Medical Education and Tabriz University of Medical Sciences To whom: We will act according to the laws of the Ministry of Health and Medical Education and Tabriz University of Medical Sciences Conditions: We will act according to the laws of the Ministry of Health and Medical Education and Tabriz University of Medical Sciences Where to obtain: Central Library of Tabriz University of Medical Sciences and Faculty of Medicine How to obtain: We will act according to the laws of the Ministry of Health and Medical Education and Tabriz University of Medical Sciences Comments:
public Mohamad Mahdi Almiski
Shayan mehr dorm, eqbal aazar ave, Resalat Street
Tabriz Iran (Islamic Republic of) 5178757395 +98 41 3441 1230 dr.mahdi.almiski@gmail.com Tabriz University of Medical Sciences scientific Mohamad Mahdi Almiski
Shayan mehr dorm, eqbal aazar ave, Resalat Street
Tabriz Iran (Islamic Republic of) 5178757395 +98 41 3441 1230 dr.mahdi.almiski@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Ability to have a normal vaginal delivery Existence of labor pain and the delivery is in the active phase. Pregnant mother wants to reduce labor pain it self. Consent of the patient and her husbend. no limit no limit Female Maternal or spouse dissatisfaction. Inability of the pregnant to remain motionless while doing work(e.g. Parkinson disease). Coagulation disorder Increased intracranial pressure (SOL). Local infections at the puncture site History of sensitivity to analgesics and other medication used in this investigation Acute lesions of the CNS Hemodynamic Disorders (e.g. hypotension or Hypovolemia). Cardiovascular Diseases that reduce the cardiac output Embryonic distress. GA <37 w, Abnormal fetal presentations, History of C/S - BMI> 40 Abnormal fetal presentations History of C/S or any surgery on the uterus History of any surgery on the uterus BMI> 40 Treatment - Drugs Treatment - Drugs Intervention group: Epidural analgesia The neuroaxial block is performed with epidural needle number 18 G . First, for the test dose: 3 ml of lidocaine 1.5%, 50 μg of fentanyl and 2.5 mg of bupivacaine is used. Then as a preservative dose 6 cc / h from this solution is injected through the catheter Intervention group: combined spinal-epidural analgesia First with a spinal needle 25G, the spinal block with 1.5ml of the same solution is performed and then the epidural block will be performed using the same method of epidural group. Maternal blood pressure. Timepoint: 5 min before performing the analgesia and then 5, 10, 20,40, 60 min after and then every 30 min until the exit of the fetus. Method of measurement: With the use of a Barometer. Maternal pulse rate. Timepoint: 5 min before performing the analgesia and then 5, 10, 20,40, 60 min after and then every 30 min until the exit of the fetus. Method of measurement: With the use of a monitor device. Maternal Oxygen Saturation. Timepoint: 5 min before performing the analgesia and then 5, 10, 20,40, 60 min after and then every 30 min until the exit of the fetus. Method of measurement: With the use of a pulse oximetry. Apgar score. Timepoint: Minuts 1 and 5. Method of measurement: Calculating. Tabriz University of Medical Sciences Approved 2018-06-11 Ethics committee of Tabriz University of Medical Sciences Central Office of the University of Medical Sciences, Golgast Street, Azadi Avenue, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)