Therapeutic Epidural Patch Versus Pain Block in the Midface for Headache

NCT03112720 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: Pro20140000026
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

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

Conditions

Postdural Puncture Headache

Outcome Measures

Primary Outcomes (3)

• 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.

Study Arms (2)

Epidural blood patch

ACTIVE COMPARATOR

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

Sphenopalatine Ganglion Block

EXPERIMENTAL

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

Interventions

Epidural Blood Patch DEVICE

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.

Epidural blood patch

Sphenopalatine Ganglion Block DRUG

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.

Sphenopalatine Ganglion Block

Eligibility Criteria

• Age: 13 Years - 92 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females ages 13-92
• Subjects have medical diagnosis of PDPH and require treatment
• Subjects who signed consent/assent

You may not qualify if:

• \<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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• New Jersey Medical School: collaborator

Study Sites (2)

New Jersey Pain Center

New Brunswick, New Jersey, 08901, United States

Location

RWJUH/Barnabus

New Brunswick, New Jersey, 08901, United States

Location

MeSH Terms

Conditions

Post-Dural Puncture Headache

Interventions

Blood Patch, Epidural; Sphenopalatine Ganglion Block

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics; Injections, Epidural; Injections, Spinal; Injections; Drug Administration Routes; Drug Therapy; Autonomic Nerve Block; Nerve Block; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative

Results Point of Contact

• Title: william grubb md
• Organization: RWJMS/Rutgers Health

grubbwr@rwjms.rutgers.edu

732 235 7827

Study Officials

• William Grubb, DDS, MD

  Rutgers Robert Wood Johnson Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor, Anesthesia

Study Record Dates

• First Submitted: September 3, 2014
• First Posted: April 13, 2017
• Study Start: September 1, 2016
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: June 22, 2023
• Results First Posted: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)