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IRCT20130803014251N11 IRCT 2026-05-16 Tehran University of Medical Sciences Effect of spinal needle size on headache after cesarean section Comparison of 22‑gauge and 25‑gauge spinal needles on the incidence, severity, and duration of post-dural puncture headache in women undergoing elective cesarean section: A randomized controlled trial in Naseriaeh, Iraq 2026-05-10 anticipated 48 Complete https://irct.ir/trial/90028 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: After consent, participants will be randomized 1:1 to the needle size 22 or 25 group using a computer-generated random sequence. Block randomization (blocks of 4 or 6) will be used to maintain balance. Allocation will be concealed using sealed opaque envelopes; the envelope will be opened only at the time of the spinal procedure, Blinding description: The anesthesiologist performing the spinal block cannot be blinded due to the nature of the intervention. However, participants and all outcome assessors will remain blinded to the needle gauge to minimize detection and performance bias. 3 Post-dural puncture headache. Intervention 1: Intervention group: In the intervention group, spinal anesthesia will be performed using a 25-gauge Quincke needle. Intervention 2: Control group: In the control group, spinal anesthesia will be performed using a 22-gauge Quincke needle. Yes - There is a plan to make this available What will be shared: Only a part of patients' demographical data and main outcomes will be shared. When: After the publishing of the results To whom: Data will be available only for researchers working on academic and university associations. Conditions: Mention of study details and authors name Where to obtain: Dr. Morteza Nasiri: Department of Operating Room, School of Allied Medical Sciences, Tehran University of Medical Sciences, Tehran, Iran How to obtain: Information will provide via the following email upon request. Mortezanasiri.or87@yahoo.com Comments:
public Dr. Morteza Nasiri
Building of Paramedical School of Tehran University of Medical Sciences, Mohammad Ebrahim Bastani Parizi Alley, Ghods Street, Enghelab Street, Tehran Province, Tehran, Iran
Tehran Iran (Islamic Republic of) 4436114177 +98 21 8898 2907 Mnasiri@sina.tums.ac.ir Tehran University of Medical Sciences scientific Dr. Morteza Nasiri
Building of Paramedical School of Tehran University of Medical Sciences, Mohammad Ebrahim Bastani Parizi Alley, Ghods Street, Enghelab Street, Tehran Province, Tehran, Iran
Tehran Iran (Islamic Republic of) 4436114177 +98 21 8898 2907 Mnasiri@sina.tums.ac.ir Tehran University of Medical Sciences Iraq Pregnant women aged 18-45 years Scheduled for elective C/S American Society of Anaesthesiologists (ASA) grade I or II Singleton pregnancy Eligible for spinal anesthesia Successful spinal anesthesia on first needle insertion Ability to understand and provide written informed consent 18 years 45 years Female History of headache disorders within the past six months, such as migraine or tension-type headache Any history of PDPH Contraindications to neuraxial anesthesia (e.g., coagulopathy, soft tissue infections at the needle insertion site, severe hypovolemia) Spinal deformity or previous spinal surgery Multiple pregnancy Body mass index greater than 40 kilograms per square meter Known neurological disorders (e.g., seizures) Prevention Prevention Intervention group: In the intervention group, spinal anesthesia will be performed using a 25-gauge Quincke needle. Control group: In the control group, spinal anesthesia will be performed using a 22-gauge Quincke needle. Incidence of post-dural puncture headache. Timepoint: Each patient will be evaluated daily for five consecutive days after the C/S, either in person or via telephone follow-up. Method of measurement: International Classification of Headache Disorders (ICHD) criteria. Severity of post-dural puncture headache. Timepoint: Each patient will be evaluated daily for five consecutive days after the C/S, either in person or via telephone follow-up. Method of measurement: Visual Analog Scale. Onset time of post-dural puncture headache. Timepoint: Each patient will be evaluated daily for five consecutive days after the C/S, either in person or via telephone follow-up. Method of measurement: A structured postoperative follow-up form. Adverse effects of the intervention. Timepoint: Each patient will be evaluated daily for five consecutive days after the C/S, either in person or via telephone follow-up. Method of measurement: A structured postoperative follow-up form. Tehran University of Medical Sciences Approved 2026-12-10 Research Ethics Committees of School of Public Health & Allied Medical Sciences of Tehran University Building of Health School of Tehran University of Medical Sciences, Poursina Alley, Ghods Street, Enghelab Street, Tehran Province, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)