An Early Phase 1 interventional study of lidocaine group ( nebulized lidocaine + saline) total volume 4 ml in Post-Dural Puncture Headache, sponsored by Minia University. Recruiting at 1 site in Egypt. Open to female participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Minia University · Early Phase 1, Interventional, and Treatment
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).
Exclusion Criteria:
Nebulization of 4 mL 0.9% saline twice daily for three days plus conventional management (consisted of bed rest in the supine position, good hydration with continuous infusion of 30 mL/kg/day lactated Ringer solution, 1 g paracetamol every 6 h. Diclofenac sodium suppository (100 mg) was given twice daily for 5 days as routine post-operative pain management
Drug: lidocaine group ( nebulized lidocaine + saline) total volume 4 ml
Nebulization of 20 µ/kg neostigmine and 10 µ/kg atropine diluted in 0.9% sterile saline ( total volume 4 ml) twice daily for three days plus conventional management ( consisted of bed rest in the supine position, good hydration with continuous infusion of 30 mL/kg/day lactated Ringer solution, 1 g paracetamol every 6 h. Diclofenac sodium suppository (100 mg) was given twice daily for 5 days as routine post-operative pain management
Drug: lidocaine group ( nebulized lidocaine + saline) total volume 4 ml
Nebulization of lidocaine 20% (60 mg) diluted in 4 ml of sterile saline 0.9% twice daily for three days plus conventional management ( consisted of bed rest in the supine position, good hydration with continuous infusion of 30 mL/kg/day lactated Ringer solution, 1 g paracetamol every 6 h. Diclofenac sodium suppository (100 mg) was given twice daily for 5 days as routine post-operative pain management
Drug: lidocaine group ( nebulized lidocaine + saline) total volume 4 ml
nebulization of 60 mg lidocaine in 4ml saline 0.9%
VAS score
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
Time frame: pre interventiomnal, 1hour, 3 ,6, 12, 24, 34, 48, 72, 96, 120 hours
Lybecker headache
Severity of headache . mild, moderate , severe headache
Time frame: pre interventiomnal,12, 24, 48, 72 hours
number of patients in need for epidural blood patch
VAS\>3
Time frame: 5 days
procedure related complication
Complications related to nebulization ( dry cough, spasm, colics......)
Time frame: 3 days
neural complications
persistent neural complications at time of discharge
Time frame: 7 days
Trans-cranial doppler
Mean flow velocity
Time frame: at onset of treatment, 24, 48, 72 hours
transcranial doppler
resistive index
Time frame: at enrollment, PREINTERVENTIONAL 24,48, 72 hours
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Minia University