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.

Minia University

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Post-Dural Puncture Headache

Treatments: Drug: lidocaine group ( nebulized lidocaine + saline) total volume 4 ml

Study type: Interventional

Funder types: Other

Identifiers

NCT06824025

1392-12-2024

Details and patient eligibility

About

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).

Enrollment: 111 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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111 participants in 3 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

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

Treatment:

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

Neostgmine group

Active Comparator group

Description:

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

Treatment:

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

Lidocaine group

Active Comparator group

Description:

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

Treatment:

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