Neostigmine + Atropine for Post-Dural Puncture Headache

Recruiting in Palo Alto (17 mi)

Overseen byMark Rollins, MD, PhD

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Mayo Clinic

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests if two medications, neostigmine and glycopyrrolate, can help new mothers with severe headaches caused by a spinal puncture during childbirth. The treatment aims to reduce the need for a more invasive procedure. Neostigmine increases brain fluid and tightens blood vessels to relieve pain, while glycopyrrolate reduces side effects.

Research Team

Mark Rollins, MD, PhD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for postpartum women who developed a headache within 72 hours after delivery, specifically due to an accidental dural puncture during epidural analgesia. It's not suitable for those with asthma, heart issues like block or arrhythmias, inability to understand pain scores or speak English, fever over 38.5 C, refusal to participate, contraindications to certain pain relievers, history of migraines or myasthenia gravis.

Inclusion Criteria

You experienced a headache within 72 hours after giving birth.

You have a headache after a specific type of needle was used for pain relief during childbirth, and there is no other reason for the headache.

Exclusion Criteria

You have asthma.

Your pain score is less than 4 on a scale from 0 to 10.

You have a condition called heart block.

See 9 more

Treatment Details

Interventions

Atropine (Anticholinergic)
Neostigmine (Cholinesterase Inhibitor)

Trial OverviewThe study tests Neostigmine and Glycopyrrolate as treatments for headaches following dural puncture in new mothers. The goal is to see if these drugs can reduce the need for an epidural blood patch in women who got headaches after the needle used during labor caused a puncture.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Postpartum dural puncture headache following dural puncture from Tuohy needleExperimental Treatment2 Interventions

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.

Atropine is already approved in United States, Canada for the following indications:

🇺🇸 Approved in United States as Atropine for: