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NCT Number: 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.

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).

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Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

nebulization of 60 mg lidocaine in 4ml saline 0.9%

Primary outcomes

  1. VAS score

    Time frame: 1,2, 3 ,5 days

    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

Secondary outcomes

  1. Lybecker headache

    Time frame: 1,2,3,5 days

    Severity of headache . mild, moderate , severe headache

  2. number of patients in need for epidural blood patch

    Time frame: 5 days

    VAS>3

  3. procedure related complication

    Time frame: 3 days

    Complications related to nebulization ( dry cough, spasm, colics......)

  4. neural complications

    Time frame: 7 days

    persistent neural complications at time of discharge

  5. hospital stay

    Time frame: 7 days

    length of hospital stay

  6. Trans-cranial doppler

    Time frame: at onset of treatment, 24, 72, 120 hours

    Mean flow velocity

  7. transcranial doppler

    Time frame: at enrollment, 24,72, 120 hours

    resistive index

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 13, 2025
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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