Therapeutic Epidural Patch Versus Pain Block in the Midface for Headache

Phase 3TerminatedNCT03112720

Rutgers, The State University of New Jersey8 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Postdural Puncture Headache

Interventions

Epidural Blood PatchDEVICE

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 BlockDRUG

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.

Eligibility

Sex: ALLMin age: 13 YearsMax age: 92 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

New Jersey Pain Center

New Brunswick, New Jersey, United States

RWJUH/Barnabus

New Brunswick, New Jersey, United States

Outcomes

Primary Outcomes

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).

Time frame: 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).

Time frame: 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).

Time frame: At 60 minutes following either therapy.

Data from ClinicalTrials.gov

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