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IRCT20160818029414N4 IRCT 2018-03-21 Zanjan University of Medical Sciences Comparision of the addition of Fentanyl and Sufentanil to Bupivacaine on labor analgesia Comparision of Fentanyl –Bupivacaine and Sufentanyl –Bupivacaine for Inthrathecal Labour Analgesia in pregnant women. 2018-01-21 anticipated 90 Complete https://irct.ir/trial/23651 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Blocked randomization, Blinding description: The mothers participating in the study after obtaining the informed consent of the spinal anesthesia and explaining the possible side effects of the medication by the anesthetist and the relevant caregiver (clinicians) without mentioning the name The analgesic group has been shown to be analgesic and the practitioner is also aware of the effects of the medication group. The outcome analyst who is the statistic consultant is also not aware of the medication used. N/A labor pain. Intervention 1: Intervention group: Intervention group: Pregnant mothers were referred to the Mousavi Hospital in the active phase of labor and their first or second term pregnancy. 50 micrograms of fentanyl and 2.5 mg of bupivacaine were injected through the number of 25 spinal needle to space of L3-L4 or L4-L5 in sitting position. Intervention 2: Intervention group: Intervention group: Intervention group: Pregnant mothers were referred to the Mousavi Hospital in the active phase of labor and their first or second term pregnancy. 5 micrograms of Sufentanyl and 2.5 mg of bupivacaine were injected through the number of 25 spinal needle to space of L3-L4 or L4-L5 in sitting position. Intervention 3: Control group: Pregnant mothers who are referred to Mousavi Hospital, who are in the active phase of labor, and their first or second term pregnancy, are examined for the course of labor. 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 No more information
public zohre pishgahi
Ayatollah Musavi hospital., Gavazang road
zanjan Iran (Islamic Republic of) 4515613113 +98 24 3313 0000 drz.pishgahi@gmail.com Zanjan University of Medical Sciences scientific Vahideh Rashtchi
Musavi Hospital,Gavazang Avenue
Zanjan Iran (Islamic Republic of) 4513956183 +98 24 3313 0000 vrasshtchi@gmail.com Zanjan University of Medical Sciences Iran (Islamic Republic of) Pregnant woman with age between 15 to 45 and with gestational age between 38 weeks and more Negative past medical history One or two gravid 15 years 45 years Female Patient dissatisfaction Infection in the site of spinal needle High intracranial pressure Coagulation disorders History of allergy to narcotic drugs or anesthetics Presence of underlying disease Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: Intervention group: Pregnant mothers were referred to the Mousavi Hospital in the active phase of labor and their first or second term pregnancy. 50 micrograms of fentanyl and 2.5 mg of bupivacaine were injected through the number of 25 spinal needle to space of L3-L4 or L4-L5 in sitting position. Intervention group: Intervention group: Intervention group: Pregnant mothers were referred to the Mousavi Hospital in the active phase of labor and their first or second term pregnancy. 5 micrograms of Sufentanyl and 2.5 mg of bupivacaine were injected through the number of 25 spinal needle to space of L3-L4 or L4-L5 in sitting position. Control group: Pregnant mothers who are referred to Mousavi Hospital, who are in the active phase of labor, and their first or second term pregnancy, are examined for the course of labor. Labor pain. Timepoint: From the time of analgesia to the end of labor or the end of anesthesia. Method of measurement: Based on the questionnaire completed by the researcher, the time is defined in terms of minutes and pain relief based on the pain ruler. Baby apgar. Timepoint: One and a five minutes after childbirth. Method of measurement: The neonatal Apgar score is based on five items: heart rate, muscle tone, baby color, respiratory effort, reflexive irritability. Heart rate less than one hundredth of a person is more than 100 points and in the absence of a score of zero. Irregular respiratory rate score is 1 and A good cry is a score of 2, and in the absence of a score of zero. Your loose muscle is zero and if you have some degrees of flexion, the score 1 and the active motions score 2. If there is no reflexive irritation, the score is zero and in the case of change The baby's face will score one and, in the case of a severe cry, score 2. The pale or blue score is zero, the pink body and The blue endings score one and the whole pink score is 2. Patient satisfaction with analgesia. Timepoint: Immediately after childbirth. Method of measurement: A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various. Zanjan University of Medical Sciences Approved 2017-08-08 Zanjan univercity of medical sciences Azadi Avenue Zanjan Zanjan Iran (Islamic Republic of)