Actively Recruiting

Early Phase 1
Age: 18Years - 35Years
FEMALE
ID06824025

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

On this page

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

Age: 18Years - 35Years
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Follow-up

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

Actively Recruiting

Loading map...

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

Similar Trials

Effect of Altitude on Postdural Puncture Headache After Caes...

Post-Dural Puncture Headache

Actively Recruiting

2 locations

Neostigmine and Glycopyrrolate for the Treatment of Post Dur...

Post-Dural Puncture Headache

Actively Recruiting

1 location

Cerebral Hemodynamics and Cerebrospinal Fluid Dynamics in Po...

Post-Dural Puncture Headache

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here