What side effects are associated with this type of intervention?

Common treatments for Post-Dural Puncture Headache (PDPH) include epidural blood patches, caffeine, and medications like Neostigmine and Glycopyrrolate. Neostigmine, an acetylcholinesterase inhibitor, can cause side effects such as bradycardia, increased salivation, and gastrointestinal disturbances. Glycopyrrolate, an anticholinergic, may lead to dry mouth, blurred vision, urinary retention, and constipation. Epidural blood patches can cause back pain, infection, and, rarely, nerve damage. Caffeine can result in insomnia, jitteriness, and gastrointestinal upset.

What prior FDA approvals exist?

The FDA has not specifically approved Neostigmine and Glycopyrrolate for the treatment of Post-Dural Puncture Headache (PDPH). However, the standard treatment for PDPH often includes conservative measures such as bed rest, hydration, and caffeine. In more severe cases, an epidural blood patch is commonly used. While acetylcholinesterase inhibitors and anticholinergic agents like Neostigmine and Glycopyrrolate are being studied for their potential benefits, they are not yet standard or FDA-approved treatments for PDPH.

What other types of research exist?

Promising novel alternatives for treating Post-Dural Puncture Headache (PDPH) include intravenous acetaminophen, which has been effective in reducing pain and opioid consumption in critically ill patients, and gabapentinoids like gabapentin and pregabalin, which are used for neuropathic pain and have shown efficacy in various pain management scenarios. Additionally, treatments like intravenous prochlorperazine and metoclopramide, which are used for acute migraine, may offer relief for PDPH due to their antiemetic and analgesic properties.

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Anticholinergic

Neostigmine + Atropine for Post-Dural Puncture Headache

Phase 2

Recruiting

Led By Mark Rollins, MD, PhD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1 hour, 8 hours, 16 hours, 24 hours, 48 hours, 1 week, and 2 weeks after intervention

Awards & highlights

Summary

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.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Potential side effects may include dry mouth from Glycopyrrolate and muscle cramps or twitching from Neostigmine. Both drugs could cause changes in heart rate and vision disturbances.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1 hour, 8 hours, 16 hours, 24 hours, 48 hours, 1 week, and 2 weeks after intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1 hour, 8 hours, 16 hours, 24 hours, 48 hours, 1 week, and 2 weeks after intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 hour, 8 hours, 16 hours, 24 hours, 48 hours, 1 week, and 2 weeks after intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of postpartum women requiring epidural blood patch

Secondary study objectives

Adverse Events

Change in pain scores

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Glycopyrrolate

2011

Completed Phase 4

~23980

Neostigmine

2020

Completed Phase 4

~2050

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Neostigmine, an acetylcholinesterase inhibitor, increases acetylcholine levels, enhancing parasympathetic activity and potentially improving cerebrospinal fluid (CSF) production, which can alleviate Post-Dural Puncture Headache (PDPH) symptoms. Glycopyrrolate, an anticholinergic agent, reduces parasympathetic activity, helping to manage symptoms like nausea associated with PDPH. Understanding these mechanisms is crucial for PDPH patients as it highlights the importance of balancing parasympathetic and sympathetic activities to manage headache and associated symptoms effectively.

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,298 Previous Clinical Trials

3,958,427 Total Patients Enrolled

1 Trials studying Post-Dural Puncture Headache

Mark Rollins, MD, PhDPrincipal InvestigatorMayo Clinic

Media Library

Atropine (Anticholinergic) Clinical Trial Eligibility Overview. Trial Name: NCT05116930 — Phase 2

Post-Dural Puncture Headache Research Study Groups: Postpartum dural puncture headache following dural puncture from Tuohy needle

Post-Dural Puncture Headache Clinical Trial 2023: Atropine Highlights & Side Effects. Trial Name: NCT05116930 — Phase 2

Atropine (Anticholinergic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05116930 — Phase 2

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