Therapeutic Epidural Patch Versus Pain Block in the Midface for Headache

Phase 3

Terminated

• Conditions: Postdural Puncture Headache
• Interventions: Device: Epidural Blood Patch; Drug: Sphenopalatine Ganglion Block

• Registration Number: NCT03112720
• Lead Sponsor: Rutgers, The State University of New Jersey

Brief 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

Detailed 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.

Study Timeline

• Study First Submitted: 2014-09-03
• Study Start: 2016-09
• Study First Submitted QC: 2017-04-07
• Study First Posted: 2017-04-13
• Primary Completion: 2020-09
• Study Completion: 2020-09
• Results First Submitted: 2021-11-10
• Status Verified: 2023-06
• Results First Submitted QC: 2023-06-15
• Last Update Submitted: 2023-06-15
• Results First Posted: 2023-06-22
• Last Update Posted: 2023-06-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epidural blood patch	Epidural Blood Patch	20ml of sterile blood is obtained from the patients arm and placed in the epidural space using standard sterile epidural access.
Sphenopalatine Ganglion Block	Sphenopalatine Ganglion Block	Cotton tip applicators are used to deliver lidocaine to the posterior nares in the area of skin overlying the Sphenopalatine gangion

Primary Outcome Measures

Name	Time	Method
Number of Headaches With a VAS Score >8/10 Prior to Initiation of Either Therapy	Prior to initiation of therapy (Epidural blood patch vs Sphenopalatine Ganglion Block).	Outcome measure will entail recording patient self-reported pain scores to quantify the level of headache pain using the Visual analog scale, meaning 0 - No pain, 1-3 - Mild Pain, 4-6 - Moderate Pain, 7-10 - Severe Pain, by way of in person assessment by pain questionnaire just prior to initiation of either therapy (Epidural blood patch vs Sphenopalatine Ganglion Block).
Number of Participants With a Headache Vas 8/10 at 30 Minutes Following Either Therapy.	At 30 minutes following either therapy.	Self-reported pain scores to quantify the level of headache pain using the Visual analog scale (as defined within the description of outcome 1 above) by way of in person assessment by pain questionnaire at 30 minutes following either therapy (Epidural blood patch vs Sphenopalatine Ganglion Block).
Number of Participants With a Headache Vas 8/10 at 60 Minutes Following Either Therapy.	At 60 minutes following either therapy.	Self-reported pain scores to quantify the level of headache pain using the Visual analog scale (as defined within the description of outcome 1 above) by way of in person assessment by pain questionnaire at 60 minutes following either therapy (Epidural blood patch vs Sphenopalatine Ganglion Block).

Trial Locations

Locations (2)

New Jersey Pain Center; 🇺🇸 New Brunswick, New Jersey, United States

RWJUH/Barnabus; 🇺🇸 New Brunswick, New Jersey, United States