Actively Recruiting

Phase 2
Age: 18Years - 54Years
FEMALE
ID05116930

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

Led by Mayo Clinic · Updated on 2026-03-23

18

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of Neostigmine and Glycopyrrolate to treat post-dural puncture headache (PDPH) in postpartum women who develop this headache after an accidental dural puncture with a Tuohy needle. The study aims to reduce the number of women with PDPH who need an epidural blood patch (EBP), which is the current standard treatment but carries some risks and contraindications. This pilot study builds on earlier findings that suggested these drugs might help reduce headache severity and EBP need. In this study, women with PDPH and a pain score of 4 or higher will receive intravenous infusions of Neostigmine (20 mcg/kg) and Glycopyrrolate (4 mcg/kg) over 10 minutes. This treatment is given every 8 hours for up to three doses or until pain is reduced to a score of 3 or less. Alongside the study drugs, patients will also receive standard supportive treatments such as hydration, caffeine, acetaminophen, ibuprofen, and pain medication as needed. Participants are carefully monitored during and after infusions for vital signs and possible side effects like muscle cramps or blurred vision. Participants will be assessed daily in the hospital for headache symptoms, and pain scores will be tracked at multiple time points up to two weeks after treatment. Researchers will monitor the number of women requiring EBP within two weeks, changes in pain levels, and any adverse events. The study includes safety monitoring with frequent blood pressure checks, continuous heart and oxygen monitoring during infusions, and follow-up evaluations to understand treatment effects and safety. Participation continues until headache resolution or decision to receive EBP, with total follow-up lasting up to two weeks after intervention.

CONDITIONS

Brief Title

Neostigmine and Glycopyrrolate for the Treatment of Headache After Dural Puncture

Who Can Participate

Age: 18Years - 54Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Post-dural puncture headache after documented dural puncture with Tuohy needle during labor epidural placement
  • Headache onset within 72 hours of delivery
  • Female participants aged 18 to 54 years
  • Headache pain score (NRS) of 4 or higher
  • Ability to understand pain scores and questionnaires
  • Ability to speak English
Not Eligible

You will not qualify if you...

  • Patient refusal to participate
  • Headache pain score less than 4
  • History of migraine headaches
  • Asthma
  • Arrhythmia or heart block
  • Myasthenia gravis
  • Inability to understand pain scores or questionnaires
  • Inability to speak English
  • Contraindication to acetaminophen or NSAIDs
  • Fever with temperature above 38.5 C
  • Prior epidural blood patch for the current headache

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 24 hours or until headache improvement

Participants receive intravenous infusions of neostigmine and glycopyrrolate every 8 hours for up to 3 doses to treat post dural puncture headache. They are monitored closely during and after infusions for side effects and pain relief.

Monitoring during each infusion and for 20 minutes after; up to 3 infusions every 8 hours

Follow-up

Duration - 2 weeks

Participants are followed up to assess pain scores and monitor for any adverse events related to treatment over a 2-week period.

Multiple assessments at baseline, 1 hour, 8 hours, 16 hours, 24 hours, 48 hours, 1 week, and 2 weeks after treatment

Trial Site Locations

Total: 1 location

1

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

Addition of Neostigmine and Atropine to Conventional Management of Postdural Puncture Headache: A Randomized Controlled Trial.

Ahmed Abdelaal Ahmed Mahmoud, Amr Zaki Mansour, Hany Mahmoud Yassin...

https://pubmed.ncbi.nlm.nih.gov/30169405