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.

NCT06824025 | Recruiting Early Phase 1

• 1 other identifier: 1392-12-2024
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• VAS score

  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

  3 days

Secondary Outcomes (7)

• Lybecker headache

  72 hours

• number of patients in need for epidural blood patch

  3 days

• procedure related complication

  3 days

• neural complications

  7 days

• hospital stay

  7 days

Study Arms (3)

Control group

PLACEBO COMPARATOR

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

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

Neostgmine group

ACTIVE COMPARATOR

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

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

Lidocaine group

ACTIVE COMPARATOR

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

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

Interventions

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

nebulization of 60 mg lidocaine in 4ml saline 0.9%

Control group; Lidocaine group; Neostgmine group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Minia University

Minya, 61511, Egypt

RECRUITING

MeSH Terms

Conditions

Post-Dural Puncture Headache

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass professor anesthesia and pain

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 13, 2025
• Study Start: February 20, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 5, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

EG (1)