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Therapeutic Epidural Patch Versus Pain Block in the Midface for Headache

Primary Purpose

Postdural Puncture Headache

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Epidural Blood Patch
Sphenopalatine Ganglion Block
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postdural Puncture Headache

Eligibility Criteria

13 Years - 92 Years (Child, Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • New Jersey Pain Center
  • RWJUH/Barnabus

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Epidural blood patch

Sphenopalatine Ganglion Block

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).
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).
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).

Secondary Outcome Measures

Full Information

First Posted
September 3, 2014
Last Updated
June 15, 2023
Sponsor
Rutgers, The State University of New Jersey
Collaborators
New Jersey Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT03112720
Brief Title
Therapeutic Epidural Patch Versus Pain Block in the Midface for Headache
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Terminated
Why Stopped
no enrollment after covid pandemic
Study Start Date
September 2016 (undefined)
Primary Completion Date
September 2020 (Actual)
Study Completion Date
September 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
Collaborators
New Jersey Medical School

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postdural Puncture Headache

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Epidural blood patch
Arm Type
Active Comparator
Arm Description
20ml of sterile blood is obtained from the patients arm and placed in the epidural space using standard sterile epidural access.
Arm Title
Sphenopalatine Ganglion Block
Arm Type
Experimental
Arm Description
Cotton tip applicators are used to deliver lidocaine to the posterior nares in the area of skin overlying the Sphenopalatine gangion
Intervention Type
Device
Intervention Name(s)
Epidural Blood Patch
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Sphenopalatine Ganglion Block
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Headaches With a VAS Score >8/10 Prior to Initiation of Either Therapy
Description
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).
Time Frame
Prior to initiation of therapy (Epidural blood patch vs Sphenopalatine Ganglion Block).
Title
Number of Participants With a Headache Vas 8/10 at 30 Minutes Following Either Therapy.
Description
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).
Time Frame
At 30 minutes following either therapy.
Title
Number of Participants With a Headache Vas 8/10 at 60 Minutes Following Either Therapy.
Description
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).
Time Frame
At 60 minutes following either therapy.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
92 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Grubb, DDS, MD
Organizational Affiliation
Rutgers Robert Wood Johnson Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
New Jersey Pain Center
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
RWJUH/Barnabus
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Therapeutic Epidural Patch Versus Pain Block in the Midface for Headache

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