RecruitingPhase 2

Neostigmine and Glycopyrrolate for the Treatment of Headache After Dural Puncture

United States18 participantsStarted 2021-11-19

Plain-language 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.

Who can participate

Age range18 Years – 54 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Number of postpartum women requiring epidural blood patch

Timeframe: 2 weeks

Trial details

NCT IDNCT05116930

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12

View on ClinicalTrials.gov More Post-Dural Puncture Headache trials