Therapeutic Epidural Patch Versus Pain Block in the Midface for Headache

NCT ID: NCT03112720

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2020-09-30

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.

Conditions

Postdural Puncture Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Epidural blood patch

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

Group Type: ACTIVE_COMPARATOR

Epidural Blood Patch

Intervention Type: 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.

Sphenopalatine Ganglion Block

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

Group Type: EXPERIMENTAL

Sphenopalatine Ganglion Block

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 92 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

New Jersey Medical School

OTHER

Sponsor Role: collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

William Grubb, M.D.

Clinical Associate Professor, Anesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

William Grubb, DDS, MD

Role: PRINCIPAL_INVESTIGATOR

Rutgers Robert Wood Johnson Medical School

Locations

New Jersey Pain Center

New Brunswick, New Jersey, United States

RWJUH/Barnabus

New Brunswick, New Jersey, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Pro20140000026

Identifier Type: -

Identifier Source: org_study_id