Therapeutic Epidural Patch Versus Pain Block in the Midface for Headache

Rutgers The State University of New Jersey

Status and phase: Terminated; Phase 3

Conditions: Postdural Puncture Headache

Treatments: Drug: Sphenopalatine Ganglion Block; Device: Epidural Blood Patch

Study type: Interventional

Funder types: Other

Identifiers

NCT03112720

Pro20140000026

Details and patient eligibility

About

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

Full description

The sphenopalatine nerve block has been used to treat headaches. Patients have headaches after epidural access from post dural puncture. We need to know if sphenopalatine nerve block will help the patient with the headache.

Enrollment: 8 patients

Sex: All

Ages: 13 to 92 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

Epidural blood patch

Active Comparator group

Description:

20ml of sterile blood is obtained from the patients arm and placed in the epidural space using standard sterile epidural access.

Treatment:

Device: Epidural Blood Patch

Sphenopalatine Ganglion Block

Experimental group

Description:

Cotton tip applicators are used to deliver lidocaine to the posterior nares in the area of skin overlying the Sphenopalatine gangion

Treatment:

Drug: Sphenopalatine Ganglion Block