Nebulized neostigmine/atropine versus nebulized lidocaine for post-dural puncture headache after cesarean delivery
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.
EARLY_PHASE1 · Minia University · NCT06824025
This trial tests whether inhaled (nebulized) neostigmine with atropine relieves post-dural puncture headache better than inhaled lidocaine in women who develop headache after spinal anesthesia for elective cesarean delivery.
Quick facts
| Phase | EARLY_PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 111 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | Female |
| Sponsor | Minia University (other) |
| Locations | 1 site (Minya) |
| Trial ID | NCT06824025 on ClinicalTrials.gov |
What this trial studies
This single-center, randomized interventional early phase I trial enrolls parturients who develop post-dural puncture headache after elective cesarean section under spinal anesthesia. Eligible women (aged 18–35) with moderate-to-severe headache (VAS ≥4 and Lybecker score ≥2) are randomized to receive nebulized neostigmine/atropine or nebulized lidocaine (total 4 ml). Headache intensity, need for rescue analgesia, and adverse events are followed after treatment to compare symptom relief and safety. The trial is conducted at Minia University and focuses on short-term headache outcomes and tolerability of the inhaled interventions.
Who should consider this trial
Good fit: Ideal candidates are women aged 18–35 who develop moderate-to-severe post-dural puncture headache after elective cesarean delivery under spinal anesthesia (VAS ≥4 and Lybecker score ≥2).
Not a fit: Patients with pregnancy-induced hypertension, active or historical bronchial asthma, prior migraine or trigeminal neuralgia, postpartum hemorrhage, emergency cesarean section, need for conversion to general anesthesia, failed spinal anesthesia, or those who refuse participation are not eligible and are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this noninvasive inhaled treatment could provide faster relief of PDPH symptoms and reduce the need for invasive procedures like an epidural blood patch.
How similar studies have performed: This inhaled neostigmine/atropine approach is largely novel for PDPH and prior related therapies (topical/local agents and systemic adjuvants) have shown mixed or limited evidence of benefit.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Minya
- Minia University — Minya, Egypt (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Post-Dural Puncture Headache