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Therapeutic Epidural Patch Versus Pain Block in the Midface for Headache

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ClinicalTrials.gov Identifier: NCT03112720
Recruitment Status : Recruiting
First Posted : April 13, 2017
Last Update Posted : April 13, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Postdural Puncture Headache Device: Epidural Blood Patch Drug: Sphenopalatine Ganglion Block

Detailed Description:
The sphenopalitine nerve block has been used to treat headaches. Patients have headaches after epidural access from post dural puncture. We need to know if sphenopalitine nerve block will help the patient with the headache.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2016
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache
Drug Information available for: Lidocaine
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Epidural blood patch
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
A device: 17 gauge Touhy 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 chloroprep. 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.
Experimental: Sphenopalatine Ganglion Block
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
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.


Outcome Measures

Primary Outcome Measures :
  1. Pain Questionnaire prior to initiation of either therapy [ Time Frame: Prior to initiation of therapy (Epidural blood patch vs Sphenopalatine Ganglion Block). ]
    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).

  2. Pain Questionnaire at 30 minutes following either therapy. [ Time Frame: At 30 minutes following either therapy. ]
    Self-reported pain scores to quantify the level of headache pain using the Visual analog scale (as defined withinin 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).

  3. Pain Questionnaire at 60 minutes following either therapy. [ Time Frame: At 60 minutes following either therapy. ]
    Self-reported pain scores to quantify the level of headache pain using the Visual analog scale (as defined withinin 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).

  4. Pain Questionnaire at 24 hours following either therapy. [ Time Frame: At 24 hours following either therapy. ]
    Self-reported pain scores to quantify the level of headache pain using the Visual analog scale (as defined withinin the description of outcome 1 above) by way of telephone based assessment by pain questionnaire at 24 hours following either therapy (Epidural blood patch vs Sphenopalatine Ganglion Block).

  5. Pain Questionnaire at 48 hours following either therapy. [ Time Frame: At 48 hours following either therapy. ]
    Self-reported pain scores to quantify the level of headache pain using the Visual analog scale (as defined withinin the description of outcome 1 above) by way of telephone based assessment by pain questionnaire at 48 hours following either therapy (Epidural blood patch vs Sphenopalatine Ganglion Block).


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 92 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03112720


Contacts
Contact: William Grubb, MD 732-235-7827 wrgrubb@aol.com

Locations
United States, New Jersey
New Jersey Pain Center Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Ann Maire Lozano, RN, MSN    732-235-3526    annmarie.lozano@rwjms.rutgers.edu   
Contact: William Grubb, MD    732-235-7827    wrgrubb@aol.com   
RWJUH/Barnabus Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: william r grubb, md    732-742-6528    wrgrubb@aol.com   
Sponsors and Collaborators
Rutgers, The State University of New Jersey
New Jersey Medical School
Investigators
Principal Investigator: William Grubb, DDS, MD Rutgers Robert Wood Johnson Medical School
More Information

Responsible Party: William Grubb, M.D., Clinical Associate Professor, Anesthesia, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT03112720     History of Changes
Other Study ID Numbers: Pro20140000026
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: April 13, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Headache
Post-Dural Puncture Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action