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IRCT20261007071343N1 IRCT 2026-10-13 Zanjan University of Medical Sciences Magnesium Sulfate Versus Gabapentin for Headache After Spinal Anesthesia for Cesarean Delivery Magnesium Sulfate Versus Gabapentin for Post-Dural Puncture Headache After Spinal Anesthesia for Cesarean Delivery 2026-11-11 anticipated 82 Pending https://irct.ir/trial/93939 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible participants will be allocated in a 1:1 ratio to magnesium sulfate or gabapentin using permuted blocks of four. Treatment groups will be coded during outcome assessment and analysis. The unit of randomization will be a patient. Online software from SealedEnvelope.com will be used for creation of the blocks. Allocation concealment will be carried out by sequentially numbered, opaque, sealed envelopes (SNOSE), Blinding description: Because the interventions differ in route of administration (intravenous versus oral), participants and the staff member administering the assigned treatment will not be blinded. A study assistant who's aware of allocation, administers the treatment; whereas the physician assessing outcomes and the statistician were blinded to treatment identity through coded group labels. 3 Postdural puncture headache (PDPH) is a potential complication associated with a lumbar puncture characterized by a bilateral frontal or occipital headache that is worse when the patient is in an upright position, nausea, neck pain, dizziness, visual changes, tinnitus, hearing loss, or radicular symptoms in the arms. These clinical features developed secondary to traction on pain-sensitive structures that experience low cerebrospinal fluid (CSF) pressure, known as intracranial hypotension, following a persistent leak of CSF at the dural puncture site.. Intervention 1: Intervention group (Gabapentin): Participants will receive a single, oral dose of 600 mg gabapentin tablet, manufactured by Tehranchemie pharmaceuticals. Intervention 2: Intervention group: (Magnesium sulfate): Participants will receive a single intravenous dose of 2 g magnesium sulfate (MgSO₄), diluted in 100 mL of 0.9% sodium chloride solution. The infusion duration will be 2 hours (1g per hour). Magnesium Sulfate ampule manufactured by Samen Pharmaceuticals will be used. 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 The team has not yet come to a single conclusion over this issue.
public Nazaninsadaat Kakatafti
Ayatollah Mousavi Hospital, Gavazang, Zanjan
Zanjan Iran (Islamic Republic of) 4513956183 +98 24 3313 0001 nazi.kaka72@gmail.com Zanjan University of Medical Sciences scientific Nazaninsadaat Kakatafti
Ayatollah Mousavi Hospital, Gavazang, Zanjan
Zanjan Iran (Islamic Republic of) 4513956183 +98 24 3313 0001 nazi.kaka72@gmail.com Zanjan University of Medical Sciences Iran (Islamic Republic of) ASA Physical Status I or II Undergoing elective cesarean delivery under spinal anesthesia and subsequently developed a positional headache clinically attributed to Post Dural Puncture Headache Absence of any contraindication for spinal anesthesia No history or report of headache before surgery Absence of Preeclampsia or Eclampsia No known allergy or reaction to Magnesium Sulfate or Gabapentin 18 years 45 years Female in case spinal anesthesia was failed and converted to general anesthesia developing focal neurological deficits suspecting any alternative cause or explanantion for the headache withdrawal of consent at any stage G97.1 Other reaction to spinal and lumbar puncture Treatment - Drugs Treatment - Drugs Intervention group (Gabapentin): Participants will receive a single, oral dose of 600 mg gabapentin tablet, manufactured by Tehranchemie pharmaceuticals. Intervention group: (Magnesium sulfate): Participants will receive a single intravenous dose of 2 g magnesium sulfate (MgSO₄), diluted in 100 mL of 0.9% sodium chloride solution. The infusion duration will be 2 hours (1g per hour). Magnesium Sulfate ampule manufactured by Samen Pharmaceuticals will be used. Decrease in headache intensity on a Visual Analogue Scale (VAS). Timepoint: both at baseline (before treatment, at the time of diagnosis) and at 1, 6, 12, 24, and 48 hours after receiving the assigned treatment. Method of measurement: Visual Analogue Scale. Zanjan University of Medical Sciences Approved 2025-11-25 Ethics committee of Zanjan University of Medical Sciences Ayatollah Mousavi Hospital, Gavazang, Zanjan Zanjan Zanjan Iran (Islamic Republic of)