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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.

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
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06824025
Enrollment
111
Registered
2025-02-13
Start date
2025-02-20
Completion date
2027-01-05
Last updated
2026-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-Dural Puncture Headache

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).

Interventions

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

nebulization of 60 mg lidocaine in 4ml saline 0.9%

Sponsors

Minia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 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

Design outcomes

Primary

MeasureTime frameDescription
VAS scorepre interventiomnal, 1hour, 3 ,6, 12, 24, 34, 48, 72, 96, 120 hoursAcute pain categorization. 10= severe umimaginable pain..... 7- 9= severe pain...4-6= moderate to severe pain ..3- 5= moderate pain .... 1-3= mild pain

Secondary

MeasureTime frameDescription
Lybecker headachepre interventiomnal,12, 24, 48, 72 hoursSeverity of headache . mild, moderate , severe headache
number of patients in need for epidural blood patch5 daysVAS\>3
procedure related complication3 daysComplications related to nebulization ( dry cough, spasm, colics......)
neural complications7 dayspersistent neural complications at time of discharge
Trans-cranial dopplerat onset of treatment, 24, 48, 72 hoursMean flow velocity
transcranial dopplerat enrollment, PREINTERVENTIONAL 24,48, 72 hoursresistive index

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 13, 2026