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.

NCT ID: NCT06824025

Last Updated: 2025-02-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-20
• Study Completion Date: 2027-01-05

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).

Conditions

Post-Dural Puncture Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control group

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

Group Type: PLACEBO_COMPARATOR

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

Intervention Type: DRUG

nebulization of 60 mg lidocaine in 4ml saline 0.9%

Neostgmine group

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

nebulization of 60 mg lidocaine in 4ml saline 0.9%

Lidocaine group

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

nebulization of 60 mg lidocaine in 4ml saline 0.9%

Interventions

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

nebulization of 60 mg lidocaine in 4ml saline 0.9%

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Minia University

OTHER

Sponsor Role: lead

Responsible Party

Mina Maher

Ass professor anesthesia and pain

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

1392-12-2024

Identifier Type: -

Identifier Source: org_study_id