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Recruiting Early Phase 1

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.

NCT06824025 · tracked via the Priya Life Science Egypt tracker
Phase
Early Phase 1
Started
2025-02-20
Last updated
2026-08-12

Condition(s) studied

Post-Dural Puncture Headache

Investigational drug(s) / intervention(s)

lidocaine group ( nebulized lidocaine + saline) total volume 4 ml

lidocaine group ( nebulized lidocaine + saline) total volume 4 ml: nebulization of 60 mg lidocaine in 4ml saline 0.9%

Study 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

Sex
FEMALE
Min age
18 Years
Max age
35 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • VAS score — pre interventiomnal, 1hour, 3 ,6, 12, 24, 34, 48, 72, 96, 120 hours
    Acute pain categorization. 10= severe umimaginable pain..... 7- 9= severe pain...4-6= moderate to severe pain ..3- 5= moderate pain .... 1-3= mild pain

Trial sites (1)

FacilityCityRegionStatus
Minia University Minya Egypt Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06824025 on ClinicalTrials.gov ↗ ← All trials in Egypt