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.
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: lidocaine group ( nebulized lidocaine + saline) total volume 4 ml.
- Who it may be relevant to
- Registry conditions: Post-Dural Puncture Headache. Basic parameters: 18 years — 35 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Drug lidocaine group ( nebulized lidocaine + saline) total volume 4 ml
nebulization of 60 mg lidocaine in 4ml saline 0.9%
Primary outcome measures
- VAS score [Time frame: 1,2, 3 ,5 days]
Secondary outcome measures (7)
- Lybecker headache [Time frame: 1,2,3,5 days]
- number of patients in need for epidural blood patch [Time frame: 5 days]
- procedure related complication [Time frame: 3 days]
- neural complications [Time frame: 7 days]
- hospital stay [Time frame: 7 days]
- Trans-cranial doppler [Time frame: at onset of treatment, 24, 72, 120 hours]
- transcranial doppler [Time frame: at enrollment, 24,72, 120 hours]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Minia University — Minya
Identifiers
NCT: NCT06824025 · 1392-12-2024