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IRCT20130803014251N13 IRCT 2026-07-15 Tehran University of Medical Sciences Comparison of aminophylline and paracetamol for the prevention of post-spinal anesthesia headache Comparison of aminophylline and paracetamol for the prevention of post-dural puncture headache in women undergoing cesarean section under spinal anesthesia: A randomized controlled trial 2026-07-13 anticipated 100 Complete https://irct.ir/trial/91580 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Participants will be randomly assigned in a 1:1 allocation ratio using a computer-generated randomization sequence. Permuted block randomization with a fixed block size of 4 will be used to ensure balanced allocation between the two study groups. Allocation concealment will be maintained using sequentially numbered, opaque, sealed envelopes, which will be opened only after confirmation of participant eligibility and successful spinal anesthesia, Blinding description: Both participants and anesthesiologist administering the study medications will be blinded to group allocation. Study drugs will be prepared by an independent nurse or pharmacist not involved in patient management or outcome assessment. Aminophylline and paracetamol will be diluted with normal saline to identical volumes and presented in identical, opaque, coded syringes. Allocation codes will be kept securely by the independent drug preparer and will not be revealed until completion of data analysis, unless unblinding is required for patient safety. Outcome assessor will remain blinded throughout the study. 3 Post-dural puncture headache. Intervention 1: Intervention group: This group will receive 250 mg of intravenous aminophylline diluted in 150 mL of 0.9% normal saline, administered immediately after delivery of the neonate and repeated at 1, 4, 8, 12, and 24 hours postoperatively. Intervention 2: Control group: This group will receive 1 g of intravenous paracetamol diluted in 100 mL of 0.9% normal saline, administered immediately after delivery of the neonate and repeated at 1, 4, 8, 12, and 24 hours postoperatively. 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 Candidate for elective cesarean delivery American Society of Anaesthesiologists (ASA) grade I or II Singleton pregnancy Eligible for spinal anesthesia Successful spinal anesthesia on first needle insertion 18 years 45 years Female Any history of post-dural puncture headache History of chronic or recurrent headache disorders within the past six months (e.g., migraine or tension-type headache) Contraindications to neuraxial anesthesia (e.g., coagulopathy, soft tissue infections at the needle insertion site, or severe hypovolemia) Spinal deformity or previous spinal surgery Multiple pregnancy Body mass index greater than 40 kilograms per square meter Failed spinal anesthesia requiring conversion to general anesthesia Known neurological disorders (e.g., seizures) Hypersensitivity or contraindication to aminophylline or paracetamol Cardiac arrhythmias, uncontrolled hypertension, or seizure disorders G97.1 Other reaction to spinal and lumbar puncture Prevention Prevention Intervention group: This group will receive 250 mg of intravenous aminophylline diluted in 150 mL of 0.9% normal saline, administered immediately after delivery of the neonate and repeated at 1, 4, 8, 12, and 24 hours postoperatively. Control group: This group will receive 1 g of intravenous paracetamol diluted in 100 mL of 0.9% normal saline, administered immediately after delivery of the neonate and repeated at 1, 4, 8, 12, and 24 hours postoperatively. 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 2026-07-12 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)