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Comparison of Nebulized Neostigmine/Atropine Versus Lidocaine in Treating Acute Post-dural Puncture Headache After Spinal Anesthesia in Women Having Elective Cesarean Section
Led by Minia University · Updated on 2026-04-30
111
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Post-dural puncture headache (PDPH) is a common and painful problem that can happen after spinal anesthesia in pregnant women having cesarean sections. It is caused by leakage of cerebrospinal fluid after a lumbar puncture, leading to headache due to brain tension and blood vessel changes. This trial studies the effects of nebulized neostigmine/atropine compared to nebulized lidocaine and placebo, aiming to find better treatments for PDPH in women aged 18 to 35 years undergoing elective cesarean sections. Participants are randomly assigned to one of three groups: one group receives nebulized saline as a placebo, another receives nebulized neostigmine and atropine, and the third group receives nebulized lidocaine. Each treatment is given twice daily for three days alongside standard care, which includes bed rest, hydration with lactated Ringer solution, paracetamol every six hours, and diclofenac suppositories for pain relief. The study compares these treatments to evaluate their effects on headache severity and other outcomes. During the trial, participants will be monitored through visual analog scale (VAS) scores for headache pain over three days, Lybecker headache classification, need for epidural blood patches, and complications over several days. Transcranial Doppler scans will be performed at the start and during follow-up to assess cerebral blood flow. Hospital stay length and neural complications will also be recorded. The total study period includes treatment and follow-up assessments to evaluate safety and effectiveness of the interventions.
CONDITIONS
Brief 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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female parturient aged 18 to 35 years
- Experiencing postpartum headache after elective cesarean section under spinal anesthesia
- Visual analog score (VAS) of headache pain 4 or higher
- Lybecker classification headache score of 2 or higher
You will not qualify if you...
- Pregnancy induced hypertension
- Emergency cesarean section
- Asthma or history of bronchial asthma
- Previous history of migraine or trigeminal neuralgia
- Postpartum hemorrhage
- Need for general anesthesia or failed spinal anesthesia
- Patient refusal to participate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 days
Participants receive nebulized neostigmine/atropine, nebulized lidocaine, or placebo twice daily for three days alongside conventional post-operative management to treat acute post-dural puncture headache.
Multiple visits during treatment period
Duration - Up to 7 days
Participants are monitored for headache relief, complications, and hospital stay outcomes up to 7 days after treatment.
Visits at 24, 72 hours and up to 7 days post-treatment
Trial Site Locations
Total: 1 location
1
Minia University
Minya, Egypt, 61511
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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