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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
No Placebo-Only Group
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
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
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
3,329 Previous Clinical Trials
3,059,697 Total Patients Enrolled
1 Trials studying Post-Dural Puncture Headache
Mark Rollins, MD, PhDPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.You have difficulty understanding and answering questions about pain and other information.Your body temperature is higher than 38.5 degrees Celsius.You experienced a headache within 72 hours after giving birth.You have a heart rhythm problem.You cannot take acetaminophen or NSAIDs for medical reasons.You have had migraines in the past.You have myasthenia gravis.You have had a procedure called epidural blood patch for this headache.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.
Research Study Groups:
This trial has the following groups:- Group 1: Postpartum dural puncture headache following dural puncture from Tuohy needle
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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