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NOT YET RECRUITING
NCT07853924
PHASE4

Effect of Intravenous Oxytocin on Post Dural Puncture Headache After Caesarean Sections

Sponsor: Assiut University

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-09

Completion Date

2027-12

Last Updated

2026-10-02

Healthy Volunteers

No

Interventions

DRUG

oxytocin

Participants 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.

DRUG

Normal Saline

Participants will receive The Saline control solution should be identical in volume and appearance to the study infusion whenever blinding is feasible