Therapeutic Epidural Patch Versus Pain Block in the Midface for Headache

Postdural Puncture Headache Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03112720
• Other study ID #: Pro20140000026
• Status: Terminated
• Phase: Phase 3
• Start date: September 2016
• Est. completion date: September 2020

Study information

• Verified date: June 2023
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 92 Years

Eligibility

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

Related Conditions & MeSH terms

• Headache
• Post-Dural Puncture Headache
• Postdural Puncture Headache

Intervention

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.

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.

Locations

Country	Name	City	State
United States	New Jersey Pain Center	New Brunswick	New Jersey
United States	RWJUH/Barnabus	New Brunswick	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	New Jersey Medical School

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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.
Primary	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.