Recruiting
Phase 2

Neostigmine & Glycopyrrolate

Sponsor:

Mayo Clinic

Code:

NCT05116930

Conditions

Post-Dural Puncture Headache

Eligibility Criteria

Sex: Female

Age: 18 - 54

Healthy Volunteers: Not accepted

Interventions

Neostigmine

Glycopyrrolate

Study Details

Brief summary:

The purpose of this study is to evaluate Neostigmine and Glycopyrrolate to treat post-dural puncture headache (PDPH) to reduce the proportion of postpartum women with a PDPH requiring epidural blood patch (EBP) who developed a PDPH after accidental dural puncture.

Conditions

Post-Dural Puncture Headache

Study ID

NCT05116930

Start date

Nov 19, 2021

Status verified date

Mar, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 54

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

18 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Postpartum dural puncture headache following dural puncture from Tuohy needle

Subjects identified as experienced a post dural puncture headache after a confirmed dural puncture from a Tuohy needle will receive an IV administration of the study medications neostigmine and glycopyrrolate.

Interventions

Neostigmine

IV infusion 20 μg/kg over 10 minutes repeated every 8 hours for a maximum of 3 doses

Glycopyrrolate

IV infusion 4 μg/kg over 10 minutes repeated every 8 hours for a maximum of 3 doses

Primary outcome measure

  • Number of postpartum women requiring epidural blood patch [ Time Frame: 2 weeks ]

Central Contacts and Locations

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Mark Rollins, MD, PhD

(507) 422-0662rollins.mark@mayo.edu

More Information

Sponsor

Mayo Clinic

Last update posted

Mar 23, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-03-23.