Post-dural puncture headache: pathogenesis, prevention and treatment.
D K Turnbull, D B Shepherd
https://pubmed.ncbi.nlm.nih.gov/14570796Actively Recruiting
Led by Mayo Clinic · Updated on 2026-03-23
18
Participants Needed
1
Research Sites
N/A
Total Duration
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
Neostigmine and Glycopyrrolate for the Treatment of Headache After Dural Puncture
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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