Neostigmine + Atropine for Post-Dural Puncture Headache
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.12345Why 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.16789
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive IV administration of neostigmine and glycopyrrolate for PDPH treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Atropine
- Neostigmine
Atropine is already approved in United States, Canada for the following indications:
- Uveitis
- Pupillary dilation
- Refraction assessment
- Amblyopia
- Cycloplegia
- Uveitis
- Pupillary dilation
- Refraction assessment
- Amblyopia
- Cycloplegia
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor