Using Neostigmine and Glycopyrrolate to Treat Headaches After Dural Puncture
Neostigmine and Glycopyrrolate for the Treatment of Post Dural Puncture Headache After Known Dural Puncture With a Tuohy Needle: A Pilot Study
This study tests if using Neostigmine and Glycopyrrolate can help new mothers with headaches after an accidental dural puncture during childbirth, reducing the need for a blood patch treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years to 54 Years |
| Sex | Female |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT05116930 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of Neostigmine and Glycopyrrolate in treating post-dural puncture headache (PDPH) in postpartum women who have experienced an accidental dural puncture during epidural analgesia. The hypothesis is that these medications will reduce the need for an epidural blood patch in women suffering from PDPH. The study focuses on women who develop headaches within 72 hours of delivery and aims to provide a more effective treatment option compared to traditional conservative therapies.
Who should consider this trial
Good fit: Ideal candidates for this study are postpartum women who have developed PDPH after a documented dural puncture with a Tuohy needle.
Not a fit: Patients who have a history of migraine headaches or other specified contraindications may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the incidence of debilitating headaches in postpartum women, improving their recovery and ability to care for their newborns.
How similar studies have performed: While there is existing evidence for conservative treatments for PDPH, the specific combination of Neostigmine and Glycopyrrolate has not been extensively tested, making this approach novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Post-dural puncture headache (PDPH) after documented dural puncture with Tuohy needle during placement of epidural analgesia for labor and no other explanation for headache (HA). * Onset of HA within 72 hours of delivery. Exclusion Criteria: * Patient refusal. * Visual analog scale (NRS) score \< 4. * History of migraine headaches. * Asthma. * Arrhythmia. * Heart block. * Myasthenia gravis. * Inability to understand pain scores and other questionnaires. * Inability to speak English. * Contraindication to acetaminophen or NSAIDs. * Temperature \> 38.5 C. * Prior EBP done for this HA.
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Mark Rollins, MD, PhD — Mayo Clinic
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.