Therapeutic Epidural Patch Versus Pain Block in the Midface for Headache

A Comparison of the Efficacy of Sphenopalatine Ganglion (SPG) Block With 5% Lidocaine Versus Epidural Blood Patch (EBP) for the Treatment of Post-Dural Puncture Headache (PDPH)

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

Study Overview

• Status: Terminated
• Conditions: Postdural Puncture Headache
• Intervention / Treatment: Device: Epidural Blood Patch; Drug: Sphenopalatine Ganglion Block

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 Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • New Jersey Pain Center
    • New Brunswick, New Jersey, United States, 08901
      • RWJUH/Barnabus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 92 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Epidural blood patch; 20ml of sterile blood is obtained from the patients arm and placed in the epidural space using standard sterile epidural access.	Device: Epidural Blood Patch; A device: 17 gauge Tuohy needle will be placed to the epidural space using the loss of resistance technique. Once positioned a sterile stylet will be replaced within the needle to maintain the sterility of the epidural space. A tourniquet may be used to identify a peripheral venous site, which will be sterilely prepped with betadine x3 and then chloraprep. Venipuncture will be performed with a device: 20gauge or larger needle. 20mL of blood will be aspirated in a sterile system into an appropriately sized syringe. After sterile transfer, this autologous blood will be slowly injected into the epidural space.
Experimental: Sphenopalatine Ganglion Block; Cotton tip applicators are used to deliver lidocaine to the posterior nares in the area of skin overlying the Sphenopalatine gangion	Drug: Sphenopalatine Ganglion Block; The drug: 5% lidocaine ointment, a local anesthetic, will be applied to the end of a device: long channeled cotton tipped applicator inserted into both nares and placed over the mucosa in the area of posterior aspect of the middle ethmoid, toward the presumed anatomic location of the sphenopalatine ganglion, evidenced by a slight resistance at the appropriate depth. 5mL of drug: 1% lidocaine solution will then be injected into the hollow shaft of the device: applicator and allowed to topically anesthetize the ganglion by gravity flow for 30 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Headaches With a VAS Score >8/10 Prior to Initiation of Either Therapy	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).	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.	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).	At 30 minutes following either therapy.
Number of Participants With a Headache Vas 8/10 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).	At 60 minutes following either therapy.

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: New Jersey Medical School
• Investigators: Principal Investigator: William Grubb, DDS, MD, Rutgers Robert Wood Johnson Medical School

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): September 1, 2020
• Study Completion (Actual): September 1, 2020

Study Registration Dates

• First Submitted: September 3, 2014
• First Submitted That Met QC Criteria: April 7, 2017
• First Posted (Actual): April 13, 2017

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 15, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders; Headache Disorders, Secondary; Headache; Post-Dural Puncture Headache
• Other Study ID Numbers: Pro20140000026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No