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IRCT20120915010841N9 IRCT 2018-08-24 Hamedan University of Medical Sciences Epidural effects on labor pain Comparison of the effect of bolus epidural injection and continuous epidural infusion of lidocaine 1% on pain, normal delivery and motor function in patients with epidural analgesia 2018-03-21 anticipated 50 Complete https://irct.ir/trial/32887 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the randomization method is used as a 4-block block. In this way, according to the sample size, 13 blocks of four are identified, and in each of these four blocks, two of each group will be written in the form of letters A or B. This means that two A and two B are written in each block, although the order of the writing of the four letters A and B will be different in each block. The periodic numbers table will then be used to determine the order of block selection, Blinding description: After determining the epidural space and placing the catheter in the epidural space, in both groups, the 10 ml lidocaine 1% plus 1 ml of sufentanil is injected through the epidural catheter placed behind the patient. Then, in the bolus group, every one hour, 10 ml lidocaine 1% through an epidural catheter is bolusly injected into the epidural space by anesthesiologist regularly until delivery.In the continuous infusion group, lidocaine 1% is infused through a continuous infusion pump at a rate of 10 ml / h into the epidural space until delivery. The questionnaire is then completed by an anesthetist nurse. In this study, the evaluator and the patient do not know the type of drug administration as bolus and continuous infusion. 2-3 Vaginal delivery under epidural analgesia. Intervention 1: First intervention group: In bolus group patients after receiving 500 ml of Ringer's serum and in sitting position, first with 18 G epidural needle (Tohy) in L3-L4 space and using the loss of resistance technique, we determine the epidural space. Then place the epidural catheter in the epidural space and In the bolus group, 10 ml of lidocaine 1% plus 1 ml of sufentanil is injected into the epidural space at the same time, and then every one hour 10 ml of lidocaine 1% is bolusly injected into the epidural space regularly until delivery by anesthesiologist. Intervention 2: Second intervention group: After receiving 500 ml of Ringer's serum and in sitting position, the first 18G epidural needle (Tohy) is inserted into space L3-L4 and using the loss of resistance technique, we determine the epidural space. Then the epidural catheter is placed in the epidural space and in the continuous infusion group, at first, 10 ml of lidocaine 1% plus 1 ml of sufentanil bolusly is injected into the epidural space, and Lidocaine 1% is then infused continuously at a rate of 10 ml / hour with continuous infusion pump that is adjusted by anesthesiologist and infused into the epidural space until delivery. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Because the study is not finished yet.
public Nahid Manouchehrian
Fatemieh Hospital, Pasdaran Street
Hamadan Iran (Islamic Republic of) 6517789971 +98 81 3827 7012 manuchehriann@gmail.com Hamedan University of Medical Sciences scientific Nahid Manouchehrian
Fatemieh Hospital, Pasdaran Street
Hamadan Iran (Islamic Republic of) 6517789971 +98 81 3827 7012 manuchehriann@gmail.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Patients with first pregnancy Aged 16 to 45 Failure to receive previous analgesic Vertex presentation ASA physical status class 1 and 2 16 years 45 years Female Epidural anesthesia contraindications (coagulation problems, hypovolemia, localized infections, high ICP and anemia) patients with ASA physical status class 3 and 4 presence of lesions and skin infections on the lumbar and back of the patient patients with poor cooperation in performing of epidural analgesia patients who did not cooperate to answer the questionnaire questions). 074.6 Other complications of spinal and epidural anaesthesia during labour and delivery Treatment - Drugs Treatment - Drugs First intervention group: In bolus group patients after receiving 500 ml of Ringer's serum and in sitting position, first with 18 G epidural needle (Tohy) in L3-L4 space and using the loss of resistance technique, we determine the epidural space. Then place the epidural catheter in the epidural space and In the bolus group, 10 ml of lidocaine 1% plus 1 ml of sufentanil is injected into the epidural space at the same time, and then every one hour 10 ml of lidocaine 1% is bolusly injected into the epidural space regularly until delivery by anesthesiologist. Second intervention group: After receiving 500 ml of Ringer's serum and in sitting position, the first 18G epidural needle (Tohy) is inserted into space L3-L4 and using the loss of resistance technique, we determine the epidural space. Then the epidural catheter is placed in the epidural space and in the continuous infusion group, at first, 10 ml of lidocaine 1% plus 1 ml of sufentanil bolusly is injected into the epidural space, and Lidocaine 1% is then infused continuously at a rate of 10 ml / hour with continuous infusion pump that is adjusted by anesthesiologist and infused into the epidural space until delivery. Labor pain. Timepoint: Before and after epidural analgesia and minutes 10, 20, 30, 40, 50, 60 after epidural analgesia and the onset and end of the second stage of labor. Method of measurement: Using a Visual Analogue Scale, that patient marks his pain on a 10-cm ruler. Progress of labor. Timepoint: During labor. Method of measurement: Measurement of the duration of the first and second stages of labor. Motor function. Timepoint: Before and after epidural analgesia and minutes 10, 20, 30, 40, 50, 60 after epidural analgesia and the onset and end of the second stage of labor. Method of measurement: Using Bromage Score. Systolic Blood Pressure. Timepoint: Before and after epidural analgesia and minutes 10, 20, 30, 40, 50, 60 after epidural analgesia and the onset and end of the second stage of labor. Method of measurement: Noninvasive blood pressure monitoring. Diastolic Blood Pressure. Timepoint: Before and after epidural analgesia and minutes 10, 20, 30, 40, 50, 60 after epidural analgesia and the onset and end of the second stage of labor. Method of measurement: Noninvasive blood pressure monitoring. Mean Arterial Pressure. Timepoint: Before and after epidural analgesia and minutes 10, 20, 30, 40, 50, 60 after epidural analgesia and the onset and end of the second stage of labor. Method of measurement: Noninvasive blood pressure monitoring. Heart Rate. Timepoint: Before and after epidural analgesia and minutes 10, 20, 30, 40, 50, 60 after epidural analgesia and the onset and end of the second stage of labor. Method of measurement: Noninvasive blood pressure monitoring. Satisfaction. Timepoint: After baby birth. Method of measurement: Ask the patient about the amount of satisfaction. Total dose of lidocaine. Timepoint: After delivery and catheter exit. Method of measurement: Calculate the number of lidocaine ampoules. Newborn Apgar. Timepoint: The first and fifth minutes after birth. Method of measurement: Examination and calculation on Apgar score. Nausea & Vomiting. Timepoint: During the first and second stages of labor. Method of measurement: Observation and ask the patient. Sedation. Timepoint: Before and after epidural analgesia and minutes 10, 20, 30, 40, 50, 60 after epidural analgesia and the onset and end of the second stage of labor. Method of measurement: Using Ramsay Score. Pruritus. Timepoint: Before and after epidural analgesia and minutes 10, 20, 30, 40, 50, 60 after epidural analgesia and the onset and end of the second stage of labor. Method of measurement: VAS Of Pruritus. Paresthesia of Lip. Timepoint: During the first and second stages of labor. Method of measurement: Ask the patient. The amount of ephedrine consumed. Timepoint: After delivery and catheter exit. Method of measurement: Calculate the amount of ephedrine consumed in mg. Need to do cesarean section. Timepoint: After baby birth. Method of measurement: observation. Hamedan University of Medical Sciences Approved 2018-06-30 Ethics committee of Hamadan University of Medical Sciences Mahdie Street, Hamadan University of Medical Sciences Hamadan Hamadan Iran (Islamic Republic of)