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

NCT07853924 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: oxytocin PDPH AFTER CS
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Post Dural Puncture Headache

Outcome Measures

Primary Outcomes (1)

• 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.

  72 hours

Study Arms (2)

Group O : Oxytocin Group

ACTIVE COMPARATOR

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.

Drug: oxytocin

Group C - Control Group

PLACEBO COMPARATOR

: 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.

Drug: Normal Saline

Interventions

oxytocin DRUG

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.

Group O : Oxytocin Group

Normal Saline DRUG

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

Group C - Control Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Patients who provide written informed consent to participate in the study.

You may not qualify if:

• 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.
• Diabetes mellitus complicated by polyneuropathy.
• ASA physical status III-IV.
• Known neurological or neuromuscular disorders.
• History of recurrent headache or migraine.
• Any contraindication to the planned conventional treatment.
• Headache attributable to another identifiable cause or clinical suspicion of a secondary headache requiring further investigation.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Post-Dural Puncture Headache

Interventions

Oxytocin; Saline Solution

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor at Anesthesia, Intensive Care and Pain Management

Study Record Dates

• First Submitted: September 27, 2026
• First Posted: October 2, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: October 2, 2026

Record last verified: 2026-09