Neostigmine and Glycopyrrolate for the Treatment of Headache After Dural Puncture

Conditions

• Post-Dural Puncture Headache

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 54 Years

Healthy Volunteers

Not accepted

Interventions

• Neostigmine — DRUG
  IV infusion 20 μg/kg over 10 minutes repeated every 8 hours for a maximum of 3 doses
• Glycopyrrolate — DRUG
  IV infusion 4 μg/kg over 10 minutes repeated every 8 hours for a maximum of 3 doses

Study Details

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.

Key Dates

Start date

Nov 19, 2021

Status verified

Mar 2026

Primary completion

Dec 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

18 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

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.

Primary Outcome Measure

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

Locations (1)

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