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Study aim
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Comparison of the Efficacy of Intravenous Dexamethasone versus Intravenous Ondansetron in Preventing Post-Dural Puncture Headache Following Spinal Anesthesia
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Design
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This study is a randomized, double-blind, three-arm, controlled clinical trial. Participants are recruited using convenience sampling and are then randomly allocated to the three study groups using simple randomization. The final sample size is 120 participants, with 40 participants in each group.
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Settings and conduct
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The study will be conducted among pregnant women undergoing cesarean section under spinal anesthesia. Participants will be recruited through convenience sampling, and allocation to the study groups will be performed using simple randomization. Data will be collected in the clinical setting using a researcher-made checklist.
Study setting and time: Hajar Hospital, Shahrekord, Iran, in 2025 (1404 in the Iranian calendar).
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Participants/Inclusion and exclusion criteria
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Patients aged 18–50 years
Absence of concomitant infectious diseases.
Absence of moderate-to-severe chronic headache within 24 hours prior to anesthesia.
No administration of analgesic drugs or medications with analgesic properties within 24 hours prior to anesthesia.
Absence of preeclampsia or gestational diabetes mellitus.
No known history of hypersensitivity or allergy to dexamethasone or ondansetron.
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Intervention groups
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Group A Receives 4 mg intravenous dexamethasone in a volume of 4 mL.
Group B Receives 8 mg intravenous ondansetron in a volume of 4 mL.
Group C Receives 4 mL intravenous distilled water (placebo
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Main outcome variables
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he main outcome variables assessed in the study include:
Incidence of post-dural puncture headache (PDPH) at 6, 12, 24, 48, and 72 hours after surgery.
Severity of PDPH at the same time points.
Incidence of surgical complications, such as wound infection and bleeding.