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IRCT20190817044544N2 IRCT 2022-01-13 Rafsanjan University of Medical Sciences Postdural puncture headache Assessment PDPH in women under elective cesarean section with two types of spinal needles 2020-07-22 anticipated 130 Complete https://irct.ir/trial/60946 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: First, using the excel file and random between function, 65 numbers were randomly selected from the numbers 1-130, which were assigned to the intervention group and the remaining numbers to the control group, then according to the number of women entering the study, the type of her group A (intervention) or B (control) was determined, Blinding description: For the participants in the study, the complication of postural puncture headache is explained and it said that two types of needles are used in this study, but each participant does not know the type of needle specifically. N/A PDPH in elective cesarean surgery. Intervention 1: Intervention group: Intervention group: Women under spinal anesthesia for elective cesarean section with Whitaker needle 25،needle insertion technique: Paramedin. Intervention 2: Control group: Women candidates for elective cesarean section under spinal anesthesia with Quincke 25 needle, Paramedin needle insertion technique. Yes - There is a plan to make this available What will be shared: Participants' personal data can be shared after not being identified When: Access period starts six months after the results are published To whom: Academic researchers and industry professionals can apply for the data Conditions: In case of data reference, their use is unrestricted Where to obtain: Rafsanjan University of Medical Sciences How to obtain: permission of vise chancellor of research and technology of RUMS Comments:
public Fatemeh Jadidi
Emam Ali Blvd., Khorasani Street, Hossaini Street, Alley 3th
Rafsanjan Iran (Islamic Republic of) 7717949921 +98 34 3428 6617 fa.jadidi.2020@gmail.com Rafsanjan University of Medical Sciences scientific Fatemeh Jadidi
Emam Ali Blvd., Khorasani Street, Hossaini Street, Alley 3th
Rafsanjan Iran (Islamic Republic of) 7717949921 +98 34 3428 6617 fa.jadidi.2020@gmail.com Rafsanjan University of Medical Sciences Iran (Islamic Republic of) Elective cesarean section women with ASA class1 15 years 45 years Female Women candidates for emergency cesarean section and underlying disease Other Other Intervention group: Intervention group: Women under spinal anesthesia for elective cesarean section with Whitaker needle 25،needle insertion technique: Paramedin Control group: Women candidates for elective cesarean section under spinal anesthesia with Quincke 25 needle, Paramedin needle insertion technique Incidence of Postdural puncture headache. Timepoint: During the first 7 days after the intervention, the evaluation is performed every day. Method of measurement: In case of PDPH after spinal anesthesia, it is stated in the questionnaire form. Severity of PDPH after spinal anesthesia. Timepoint: It is evaluated daily for seven days after cesarean section. Method of measurement: Visual analogue scale. Days of PDPH. Timepoint: During seven days follow up after spinal block how many days PDPH occurs. Method of measurement: In case of this type of headache, complete the questionnaire on the number of days of PDPH. If PDPH occurs after spinal anesthesia, it is necessary to take analgesic within seven days or not. Timepoint: During seven days follow up after spinal block,In case of PDPH، number of times the need for analgesic in total is evaluated. Method of measurement: The number of times the need for analgesic during seven days is recorded in the questionnaire. There is restriction of movement in sleeping to sitting or sitting to standing. Timepoint: During seven days of follow up of PDPH. Method of measurement: The questionnaire completes the movement restriction section. Is there associated symptoms and signs Includes neck pain, shoulder pain, nausea, sensitivity to sound, light. Timepoint: follow up during seven days after spinaL block. Method of measurement: In the questionnaire, the items are recorded in case of occurrence. Rafsanjan University of Medical Sciences Approved 2020-05-23 Ethics Committee of Rafsanjan University of Medical Sciences Emam Ali Blvd., Main building of Medical sciences University Rafsanjan Kerman Iran (Islamic Republic of)