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

Status

Not yet recruiting

Phase

Phase 4

Enrollment

100 participants (estimated)

Sponsor

Assiut University · Other

Design

Randomized · Single masking

Countries

Not stated

Start

Sept 2026 (estimated)

Primary completion

Sept 2027 (estimated)

Completion

Dec 2027 (estimated)

First posted

2 Oct 2026

Last update posted

2 Oct 2026

Conditions

Post Dural Puncture Headache

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.

• Active comparator

  Group O : Oxytocin Group

  Participants will receive standardized conventional treatment for PDPH plus 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.

• Placebo comparator

  Group C - Control Group

  : Participants will receive the same standardized conventional treatment for PDPH plus an equivalent control infusion without oxytocin. The control solution should be identical in volume and appearance to the study infusion whenever blinding is feasible.

1. the change in headache pain intensity

   Time frame · 72 hours

   Registry description

   the change in headache pain intensity (VAS/NRS) from baseline immediately before treatment to a predefined primary assessment time point after treatment.

No study cites this trial.