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.
- Conditions
- Post-Dural Puncture Headache
- Interventions
- Drug: lidocaine group ( nebulized lidocaine + saline) total volume 4 ml
- Registration Number
- NCT06824025
- Lead Sponsor
- Minia University
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 111
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group lidocaine group ( nebulized lidocaine + saline) total volume 4 ml 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 Neostgmine group 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 Lidocaine group 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
- Primary Outcome Measures
Name Time Method VAS score 3 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 Outcome Measures
Name Time Method Lybecker headache 72 hours Severity of headache . mild, moderate , severe headache
number of patients in need for epidural blood patch 3 days VAS\>3
procedure related complication 3 days Complications related to nebulization ( dry cough, spasm, colics......)
neural complications 7 days persistent neural complications at time of discharge
hospital stay 7 days length of hospital stay
Trans-cranial doppler at onset of treatment, 24, 72 hours Mean flow velocity
transcranial doppler at enrollment, 24,72 hours resistive index
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