Neostigmine + Atropine for Post-Dural Puncture Headache

Age: 18 - 65

Sex: Female

Trial Phase: Phase 2

Sponsor: Mayo Clinic

Disqualifiers: Migraine, Asthma, Arrhythmia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 24 hours

18 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a combination of Neostigmine (which enhances nerve signals) and Atropine (which blocks certain nerve signals) can alleviate headaches that some women experience after childbirth, particularly when an epidural penetrates too deeply. The aim is to determine if these medications can reduce the need for an epidural blood patch, a common treatment for these headaches. Suitable participants are women who develop a headache within three days after giving birth, with no other cause for their headache. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using neostigmine and atropine together has been studied for treating headaches following certain medical procedures, such as a spinal tap. These studies have evaluated the effectiveness of this combination for this specific type of headache. Participants have generally tolerated this treatment well, with no serious side effects consistently reported.

While detailed safety information is limited, the fact that these drugs are being tested in a study suggests they are reasonably safe. Neostigmine and atropine have been used safely in other medical contexts, which adds confidence to their use here.

For those considering joining a trial with these treatments, current data indicates that the combination is generally well-tolerated. Discuss any questions or concerns with a healthcare provider. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for post-dural puncture headache?

Most treatments for post-dural puncture headache, such as epidural blood patches or caffeine, focus on alleviating symptoms. However, the combination of neostigmine and atropine offers a fresh approach by targeting the underlying cause. Neostigmine works by enhancing acetylcholine levels, potentially restoring balance in the nervous system, while atropine helps manage side effects. Researchers are excited about this treatment because it could offer a more direct and potentially quicker relief for patients who suffer from these debilitating headaches.

What evidence suggests that Neostigmine and Atropine might be effective for post-dural puncture headache?

Research has shown that a combination of neostigmine and atropine effectively treats post-dural puncture headaches (PDPH), which occur after a spinal tap. One study found that this combination provides fast pain relief and significantly reduces pain levels compared to other treatments. In this trial, participants experiencing PDPH will receive neostigmine and glycopyrrolate, a compound similar to atropine, to assess its effectiveness. Patients who received neostigmine and atropine in previous studies reported better pain relief at all times, as measured by a simple pain scale. This treatment also helped avoid the need for an epidural blood patch, a procedure often used when other treatments fail. These findings suggest that neostigmine and atropine could be a promising option for managing PDPH. ^{1 6 7 8 9}

Who Is on the Research Team?

Mark Rollins, MD, PhD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 days

In-hospital assessment

Treatment

Participants receive IV administration of neostigmine and glycopyrrolate for PDPH treatment

Up to 24 hours

Continuous monitoring during hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Daily in-hospital monitoring, followed by weekly check-ins

What Are the Treatments Tested in This Trial?

Interventions

• Atropine
• Neostigmine

Trial Overview

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.

How Is the Trial Designed?

Group I: Postpartum dural puncture headache following dural puncture from Tuohy needle Experimental Treatment 2 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:

• Uveitis
• Pupillary dilation
• Refraction assessment
• Amblyopia
• Cycloplegia

Approved in Canada as Atropine for:

• Uveitis
• Pupillary dilation
• Refraction assessment
• Amblyopia
• Cycloplegia

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10331525/

Evaluation of the Preventive Effects of Neostigmine Plus ...

The aim of this study is evaluating the effects of intravenous prescription of neostigmine plus atropine 15 minutes after dural puncture on incidence and ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10622397/

Neostigmine and atropine as a treatment for postdural ...

The combination of neostigmine and atropine demonstrates a rapid onset of action, providing patients with effective analgesia while avoiding the ...

3.

academic.oup.com

academic.oup.com/qjmed/article/116/Supplement_1/hcad069.098/7247635

Addition of Neostigmine and Atropine to Conventional ...

A combination of neostigmine and atropine are effective in managing PDPH by reducing the associated VAS score and preventing persistence of headache.

4.

uspharmacist.com

uspharmacist.com/article/neostigmine-as-intervention-for-postdural-puncture-headache

Neostigmine as Intervention for Postdural Puncture ...

Pain scores were statistically better in patients receiving neostigmine/atropine at all time points measured (P <0.001) and no epidural blood ...

5.

researchgate.net

researchgate.net/publication/327353704_Addition_of_Neostigmine_and_Atropine_to_Conventional_Management_of_Postdural_Puncture_Headache_A_Randomized_Controlled_Trial

Addition of Neostigmine and Atropine to Conventional ...

Results: Visual analog scale scores were significantly better (P< .001) with neostigmine/atropine than with saline treatment at all time ...

6.

mayo.edu

mayo.edu/research/clinical-trials/cls-20523446

Neostigmine and Atropine for the Treatment of Headache ...

The purpose of this study is to evaluate Neostigmine and Glycopyrrolate to treat post-dural puncture headache (PDPH)

7.

asahq.org

asahq.org/standards-and-practice-parameters/statement-on-post-dural-puncture-headache-management

Statement on Post-Dural Puncture Headache Management

Additionally, emerging data from 5 retrospective and 3 prospective studies support an association between PDPH, especially after unintentional dural puncture ...

8.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2808365

Consensus Practice Guidelines on Postdural Puncture ...

These practice guidelines provide a framework for individual clinicians to assess risk, confirm diagnosis, and adopt a systematic approach to management of ...

9.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06824025

Study Details | NCT06824025 | Comparison of Nebulized ...

Comparison of Nebulized Neostigmine/Atropine Versus Lignocaine in Treating Acute Post-dural Puncture Headache Following Subarachnoid Block in Parturient ...