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Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 to 54 Women only

Using Neostigmine and Glycopyrrolate to Treat Headaches After Dural Puncture

Official title: Neostigmine and Glycopyrrolate for the Treatment of Post Dural Puncture Headache After Known Dural Puncture With a Tuohy Needle: A Pilot Study

Run by Mayo Clinic · NCT05116930 · Data updated 2026-11-12

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.

More Post-Dural Puncture Headache trials

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years to 54 Years
SexWomen only
Enrollment18 (estimated)
SponsorMayo Clinic
Academic / other
Locations1 site (Rochester, Minnesota)
StatusRecruiting
StartedNovember 19, 2021
Main results expectedDecember 2027
Study endsDecember 2027
Registry record updatedMarch 23, 2026
Trial IDNCT05116930 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are postpartum women who have developed PDPH after a documented dural puncture with a Tuohy needle.

Probably not a fit

Patients who have a history of migraine headaches or other specified contraindications may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Mayo Clinic in Rochester
    Rochester, Minnesota, United States     Recruiting

Study contacts

  • Principal investigator: Mark Rollins, MD, PhD — Mayo Clinic

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.