NCT06824025 Comparison of Nebulized Neostigmine/Atropine Versus Lignocaine in Treating Acute Post-dural Puncture Headache Following Subarachnoid Block in Parturient Undergoing Elective Cesarean Section. A Randomized, Clinical Trial.
| NCT ID | NCT06824025 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Minia University |
| Condition | Post-Dural Puncture Headache |
| Study Type | INTERVENTIONAL |
| Enrollment | 111 participants |
| Start Date | 2025-02-20 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 111 participants in total. It began in 2025-02-20 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Post-dural puncture headache (PDPH) is a common and debilitating complication of spinal anesthesia in pregnant patients undergoing cesarean sections, with an incidence ranging from 0.5% to 2% (1). The International Headache Society (IHS) defines PDPH as a headache occurring within 4 days of a lumbar puncture, caused by cerebrospinal fluid (CSF) leakage through the dural puncture (2). Although the exact cause of PDPH is not fully understood, it is thought to occur due to cerebrospinal fluid loss through dural tears, which leads to tension on pain-sensitive intracranial structures and reflex, uncontrolled cerebral vasodilation leading to severe agonizing tension headache (3). Treatment options include proper hydration, maintaining a supine position, caffeine, paracetamol, nonsteroidal anti-inflammatory drugs (NSAIDs). Many adjuvants have been questioned for their therapeutic effectiveness in enhancing conservative medical treatments, with conflicting results (4). For example, sumatriptan, theophylline and dexmedetomidine have been extensively studied. Neostigmine has emerged as a promising pharmacological adjuvant for conservative management. Neostigmine increases the serum level of acetylcholine via inhibition of cholinesterase (5). This action mediates cerebral vasoconstriction via nicotinic receptors, thus antagonizing the unopposed vasodilatation occurred due to dural tear. Lidocaine, on the other hand, can mediate sphenopalatine ganglion block which is responsible for pain signals transmission from the face (6).
Eligibility Criteria
Inclusion Criteria: * 18-35 years old parturient with post partum headache after elective CS under spinal anesthesia with visual analog score (VAS) ≥ 4 \[14\] and Lybecker classification score ≥ 2 Exclusion Criteria: * Pregnancy induced hypertension * Emergency C.S * Asthmatic candidates * Previous history of migraine or trigeminal neuralgia * History of bronchial asthma * Post partum hemorrhage * Need for GA , failed spinal anesthesia * Patient refusal
Frequently Asked Questions
Who can join the NCT06824025 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 35 Years, studying Post-Dural Puncture Headache. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06824025 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06824025 currently recruiting?
Yes, NCT06824025 is actively recruiting participants. Visit ClinicalTrials.gov or contact Minia University to inquire about joining.
Where is the NCT06824025 trial being conducted?
This trial is being conducted at Minya, Egypt.
Who is sponsoring the NCT06824025 clinical trial?
NCT06824025 is sponsored by Minia University. The trial plans to enroll 111 participants.