Oral Gabapentin vs IV Neostigmine/Atropine vs Both for Preventing PDPH
Official title: Beyond the Epidural Blood Patch: Combined Oral Gabapentin and Intravenous Neostigmine/Atropine for Prevention of Post Dural Puncture Headache After Cesarean Section Under Spinal Anaesthesia
Run by Assiut University · NCT07916116 · Data updated 2026-11-12
This study tests whether taking gabapentin by mouth, getting neostigmine with atropine by IV, or using both can help prevent postdural puncture headache after spinal anesthesia in pregnant patients.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 40 Years |
| Sex | Women only |
| Enrollment | 292 (estimated) |
| Sponsor | Assiut University Academic / other |
| Locations | 1 site (Asyut) |
| Status | Recruiting |
| Started | March 1, 2026 |
| Main results expected | March 1, 2027 |
| Study ends | May 1, 2027 |
| Registry record updated | November 4, 2026 |
| Trial ID | NCT07916116 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Pregnant individuals undergoing elective cesarean section with spinal anesthesia, BMI 25–35, and no major medical comorbidities as specified by the inclusion criteria.
✕Probably not a fit
Patients with emergency cesarean sections, chronic headaches or prior PDPH, chronic pain requiring regular analgesics, substance use, or significant organ or psychiatric disorders may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional trial compares three approaches to prevent postdural puncture headache (PDPH) following spinal anesthesia for cesarean delivery: oral gabapentin, intravenous neostigmine with atropine, and a combination of both. It targets pregnant women with a single full-term fetus and BMI 25–35, across Phase 2 and Phase 3. Outcomes focus on the incidence and severity of PDPH, plus safety and tolerability of the regimens. The study reflects existing literature on pharmacologic prophylaxis for PDPH and explores whether a combination strategy offers added benefit. Conducted at Assiut University Hospital, the trial is sponsored by Assiut University with no listed collaborators.
Why it matters
Potential benefit: If successful, the regimen(s) could reduce the risk or severity of PDPH after spinal anesthesia in cesarean deliveries, improving maternal comfort and recovery.
How similar studies have gone: Prior pharmacologic approaches have shown varying success for PDPH prevention; this study tests a novel comparison including a combination therapy in a Phase 2/3 framework.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Scheduled for elective CS under spinal anesthesia. * BMI between 25 and 35 kg/m2. * ASA 11 primigravida or multigravida. * Pregnant in a single full-term fetus. Exclusion Criteria: * Emergency CS. * Chronic headache or previous PDPH. * Any type of chronic pain and those on regular analgesics or anti-epileptic medications. * Substance abuse. * Smoking. * Chronic or gestational hypertension. * hypersensitivity to one of the used drugs. * liver, kidney, neurological and psychiatric disorders. * patient refusal
Where it's running
-
Assiut University hospital
Asyut, Egypt Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.