TerminatedPhase 3

Therapeutic Epidural Patch Versus Pain Block in the Midface for Headache

Stopped: no enrollment after covid pandemic

United States8 participantsStarted 2016-09

Plain-language summary

The purpose of this study is to compare a pain block in the midface, versus the traditional, more invasive, therapeutic epidural patch for the treatment of headaches

Who can participate

Age range

13 Years – 92 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Males and females ages 13-92 * Subjects have medical diagnosis of PDPH and require treatment * Subjects who signed consent/assent Exclusion Criteria: * \<13 years of age * Pregnancy * Subjects with heart failure * Subjects already being treated with lidocaine patch or other vehicle for chronic pain * Non-english speaking subjects * Subjects with platelets \<100,000 * Subjects that are septic * Subjects with an allergy to lidocaine * Subjects with known nasal polyps * Subjects with recent neurological event * Subjects on anticoagulant therapy * Subjects that received prior therapy with SPG block or EBP

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Headaches With a VAS Score >8/10 Prior to Initiation of Either Therapy

Timeframe: Prior to initiation of therapy (Epidural blood patch vs Sphenopalatine Ganglion Block).

Number of Participants With a Headache Vas 8/10 at 30 Minutes Following Either Therapy.

Timeframe: At 30 minutes following either therapy.

Number of Participants With a Headache Vas 8/10 at 60 Minutes Following Either Therapy.

Timeframe: At 60 minutes following either therapy.

Trial details

NCT IDNCT03112720

SponsorRutgers, The State University of New Jersey

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-09

Results submitted2021-11-10

View on ClinicalTrials.gov More Postdural Puncture Headache trials