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 range13 Years – 92 Years

SexALL

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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

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