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.

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 111 (estimated)
• Sponsor: Minia University · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Post-Dural Puncture Headache

Interventions

Type	Name	Description
DRUG	lidocaine group ( nebulized lidocaine + saline) total volume 4 ml	nebulization of 60 mg lidocaine in 4ml saline 0.9%

Timeline

• Start date: 2025-02-20
• Primary completion: 2027-01-01
• Completion: 2027-01-05
• First posted: 2025-02-13
• Last updated: 2025-02-13