About this trial
Spinal anesthesia is the preferred anesthetic technique for cesarean section because of its advantages over epidural and general anesthesia. It is simple to perform, economical, provides rapid onset of anesthesia, and produces satisfactory muscle relaxation. However, spinal anesthesia may be associated with adverse effects, including nausea, vomiting, back pain, and post-dural puncture headache (PDPH)(1).
PDPH is a well-recognized complication of dural puncture. It is typically characterized by a headache that is fronto-occipital in type after spinal anesthesia puncture which gets worse after 15 minutes of standing or sitting and relieved after 15 minutes of lying down(3). The incidence of PDPH remains considerably high in younger women population reaching 20.6% which was reported in 2025(10). Most cases develop within the first few days following dural puncture. Obstetric patients are particularly susceptible because female sex, young age, and pregnancy are recognized risk factors(3).
PDPH can significantly interfere with maternal comfort, mobility, breastfeeding, and infant care, and may prolong hospitalization and increase healthcare utilization.
Oxytocin is a neurohypophyseal hormone with recognized peripheral and central effects(5). In addition to its established obstetric actions, oxytocin has been investigated for potential analgesic and neurovascular effects. Previous work has suggested a possible role of oxytocin in headache modulation(7-8); however, evidence regarding intravenous oxytocin as a treatment for established PDPH remains limited(8).
The present study is designed to evaluate whether intravenous oxytocin, when added to standardized conventional treatment, can reduce the severity and duration of established PDPH after cesarean section performed under spinal anesthesia, compared with conventional treatment alone(11).
Although several conservative and interventional approaches are available for PDPH, there is limited evidence regarding intravenous oxytocin as an adjunctive treatment for established PDPH. A randomized controlled trial comparing standardized conventional treatment with conventional treatment plus intravenous oxytocin may provide more reliable evidence regarding the clinical efficacy and safety of this intervention.
Intravenous oxytocin administered as an adjunct to standardized conventional treatment will reduce the severity of established PDPH and may shorten its duration and decrease the requirement for rescue analgesia compared with conventional treatment alone.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female patients aged >18 and ≤45 years.
American Society of Anesthesiologists (ASA) physical status I-II.
Patients undergoing cesarean section under spinal anesthesia.
Patients who develop clinically established PDPH during postoperative follow-up.
Disqualifiers
Patient refusal to participate.
Known hypersensitivity or allergic reaction to oxytocin.
Significant cardiac disease or other clinically important cardiovascular instability.
Significant hepatic or renal disease.
Trial design
Parallel
Treatments tested in this trial
oxytocin
DrugParticipants will receive intravenous oxytocin with a dose of 15 IU of oxytocin diluted in 500 ml normal saline and infused slowly over 1 hour every 12 hours for a duration of 24 hours.
Normal Saline
DrugParticipants will receive The Saline control solution should be identical in volume and appearance to the study infusion whenever blinding is feasible
Treatment groups
Trial outcomes
Primary outcomes
the change in headache pain intensity
the change in headache pain intensity (VAS/NRS) from baseline immediately before treatment to a predefined primary assessment time point after treatment.
Locations
Sponsors and contacts
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