Clinical trial 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.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Post-Dural Puncture Headache
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2025-02-13
Enrollment: 111
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: VAS score
timeFrame: 3 days
Secondary outcomes:
measure: Lybecker headache
timeFrame: 72 hours
measure: number of patients in need for epidural blood patch
timeFrame: 3 days
measure: procedure related complication
timeFrame: 3 days
measure: neural complications
timeFrame: 7 days
measure: hospital stay
timeFrame: 7 days
measure: Trans-cranial doppler
timeFrame: at onset of treatment, 24, 72 hours
measure: transcranial doppler
timeFrame: at enrollment, 24,72 hours
Other outcomes:
Locations:
Study officials:
References: