]>
IRCT20170515033986N3 IRCT 2022-01-30 Oroumia University of Medical Sciences The effect of fentanyl on headache after cesarean section Investigation of the intrathecal fentanyl effect on post spinal anesthesia headache in patients undergoing elective cesarean section 2021-11-22 anticipated 56 Complete https://irct.ir/trial/61204 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be divided into intervention and control groups using block randomization based on generated numbers by random allocation software, Blinding description: Current study is a double blind study. The patient and the person who will be assessed the outcomes (anesthesia assistant) will be blind about the intervention or control groups. therefore, the drugs will be prepared and coded by another anesthesiologist or anesthesia assistant, and the spinal anesthesia will be performed by anesthesia assistant (principal investigator). 3 Headache after cesarean section. Intervention 1: Intervention group: The spinal anesthesia will be performed using hyperbaric bupivacaine 0.5% (2.5 ml) and 25 micrograms of fentanyl (0.5 ml). Fentanyl is a product of Caspian Pharmaceutical Company. Hyperbaric bupivacaine 0.5% is a product of the French pharmaceutical company, MYLAN S.A.S. The drugs are injected as a single dose. Intervention 2: Control group: The spinal anesthesia will be performed only using hyperbaric bupivacaine 0.5% (2.5 ml). No opioid will be used intrathecally. This drug is a product of the French pharmaceutical company, MYLAN S.A.S. The drug is injected as a single dose. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Dr. Nazli Karami
Mahzad hospital, Hassani Ave., Urmia, Iran.
Urmia Iran (Islamic Republic of) 57157-81351 +98 44 3198 8293 karami.n@umsu.ac.ir Oroumia University of Medical Sciences scientific Dr. Nazli Karami
Mahzad hospital; Hassani Ave; Urmia; Iran.
Urmia Iran (Islamic Republic of) 57157-81351 +98 44 3198 8293 karami.n@umsu.ac.ir Oroumia University of Medical Sciences Iran (Islamic Republic of) Women undergoing elective cesarean section under spinal anesthesia Women aged 15 to 35 years Patients with class ASA I and ASA II 15 years 35 years Female Any contraindication for spinal anesthesia A history of migraine or chronic headache Mental diseases Neurological diseases Epilepsy Coagulation disorders Drug abusers Eclampsia and preeclampsia during pregnancy G44 Other headache syndromes Treatment - Drugs Treatment - Drugs Intervention group: The spinal anesthesia will be performed using hyperbaric bupivacaine 0.5% (2.5 ml) and 25 micrograms of fentanyl (0.5 ml). Fentanyl is a product of Caspian Pharmaceutical Company. Hyperbaric bupivacaine 0.5% is a product of the French pharmaceutical company, MYLAN S.A.S. The drugs are injected as a single dose. Control group: The spinal anesthesia will be performed only using hyperbaric bupivacaine 0.5% (2.5 ml). No opioid will be used intrathecally. This drug is a product of the French pharmaceutical company, MYLAN S.A.S. The drug is injected as a single dose. Frequency of headaches. Timepoint: In recovery, 6, 12 and 24 hours after surgery. Method of measurement: self-reporting. The severity of the headache. Timepoint: In recovery, 6, 12 and 24 hours after surgery. Method of measurement: Verbal Rating Scale (VRS). Mean arterial blood pressure. Timepoint: In recovery, 6, 12 and 24 hours after surgery. Method of measurement: Monitoring. Heart rate. Timepoint: In recovery, 6, 12 and 24 hours after surgery. Method of measurement: Monitoring. Oroumia University of Medical Sciences Approved 2021-11-01 Ethics Committee of Urmia University of Medical Sciences Urmia University of Medical Sciences, Resalat street, Jahad Blvd., Urmia, Iran. Urmia West Azarbaijan Iran (Islamic Republic of)