What this study is
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.
What's being tested
- Neostigmine
Intervention · DRUG
IV infusion 20 μg/kg over 10 minutes repeated every 8 hours for a maximum of 3 doses
- Glycopyrrolate
Intervention · DRUG
IV infusion 4 μg/kg over 10 minutes repeated every 8 hours for a maximum of 3 doses
Study details
- Official title
- Neostigmine and Glycopyrrolate for the Treatment of Post Dural Puncture Headache After Known Dural Puncture With a Tuohy Needle: A Pilot Study
- Sponsor
- Mayo Clinic
- Conditions
- Post-Dural Puncture Headache
- Enrolling
- 18 people
- Starts
- 2021-11-19
- Est. completion
- 2027-12
- Design
- Open-label, single group, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 54 YearsSex FEMALEHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (1)
1 openMayo Clinic in Rochester
Rochester, Minnesota, United States
- Mark Rollins, MD, PhD · Contact(507) 422-0662rollins.mark@mayo.edu
Recruiting
Study team
Sponsor
Mayo Clinic
Study ID 21-009530
Principal investigator
Mark Rollins, MD, PhD
Mayo Clinic
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.