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Sphenopalatine Ganglion Nerve Block for Postdural Puncture Headache in Obstetrics (SNoB)

This study is currently recruiting participants.
Verified July 2017 by Washington University School of Medicine
Sponsor:
ClinicalTrials.gov Identifier:
NCT03181464
First Posted: June 8, 2017
Last Update Posted: July 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Washington University School of Medicine
  Purpose

During labor and delivery, pregnant women may choose to receive pain relief called epidural analgesia, which is the delivery of a numbing agent through the back and into a body space around the spinal column. This numbs the area of the stomach and the pelvis. Typically the numbing agent is lidocaine, which is a local anesthetic like your dentist uses. Some times the numbing agent is combined with another medication that causes drowsiness and relieves pain called a narcotic. One of the risks associated with having this kind of pain relief is unintentional puncture of a sheath of tissue that surrounds and protects the spinal cord when inserting the needle. This sheath is called the dura. This would cause the fluid surrounding the spinal cord to leak out and this would cause a headache. This headache is called a post-dural puncture headache [PDPH]. The headache can be mild or severe. Rarely, PDPH can be serious and cause bleeding or small clots in the brain and damage to nerves that come out of the brain.

The purpose of this study is to test the use of a technique that uses a hollow cotton swab [no needles] to numb a nerve cell cluster that sits at the very back of the nasal cavity. The anatomical name for this nerve cell cluster is the sphenopalatine ganglion. This has been done before at BJH and other hospitals with positive results, but no formal studies have been conducted here. Also, the sphenopalatine ganglion [SPG] has been the treatment target for other kinds of headaches. To numb the SPG, a hollow tip cotton swab [like a long Q-Tip] is inserted through the nose to the back of the nasal cavity and a solution of numbing agent is slowly pumped through the hollow Q-tip. This study will include a group that will receive a salt solution through the swab instead of a numbing agent. Subjects will be offered BJH standard care for their headache if they do not have relief from the study procedures. Standard care would be decided by their treating physician and may include oral pain medications and/or medications like ibuprofen [Motrin] or they could have a procedure called an epidural blood patch. This is performed by injecting a small amount of the patient's own blood into the areas of the spinal column where the original epidural anesthesia was injected in order to "patch" the leaks in the dura.


Condition Intervention Phase
Postdural Puncture Headache Cerebrospinal Fluid Leak Spinal; Puncture, Complications, Headache Drug: Lidocaine 4% Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Randomized, double-blind, placebo-controlled cross-over trial
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Sphenopalatine Ganglion Nerve Block for Postdural Puncture Headache in Obstetrics

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Subject-reported analgesia [ Time Frame: 1 hour after infusion ]
    Number of subjects reporting resolution of headache


Secondary Outcome Measures:
  • Subject-reported lack of effectiveness [ Time Frame: 1 hour after infusion ]
    Number of subjects reporting no impact of treatment on headache and requesting blood patch


Estimated Enrollment: 50
Anticipated Study Start Date: August 15, 2017
Estimated Study Completion Date: May 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: experimental - lidocaine 4%
Continuous infusion lidocaine at 3ml/hr for 1 hour bilaterally onto the posterior wall of the nasopharynx.
Drug: Lidocaine 4%
lidocaine solution
Other Name: Xylocaine
Placebo Comparator: placebo comparator
Continuous infusion saline at 3ml/hr for 1 hour bilaterally onto the posterior wall of the nasopharynx
Drug: Placebo
saline .9% injection
Other Name: saline

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women, 1 day postpartum
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A parturient who received an epidural or CSE for either labor or cesarean delivery - including attempted epidural; irrespective of whether a diagnosis of inadvertent spinal was noted at the time.
  • A patient complaining of symptoms of postural headache consistent with postdural puncture headache. This is defined by the ICHD-II (International Classification of Headache Disorders-II) as one of the following symptoms to be present: headache, neck stiffness, tinnitus, hypoacusis (auditory deficit), photophobia, or nausea - symptoms which occur within 15 minutes of moving to an upright position (sitting or standing) and resolving within 15 minutes of moving to the supine position.

Exclusion Criteria:

  • Single-shot spinal anesthesia (unless an epidural was attempted).
  • Epidural performed for non-obstetric indications.
  • Patient with a clinically suspected diagnosis of meningitis, intracranial hemorrhage or venous thrombosis - unless these have been excluded by neurological assessment and/or imaging as appropriate for normal clinical management.
  • Symptoms or signs of cranial nerve palsy: e.g., diplopia.
  • Contraindication to performance of epidural blood patch.
  • Patient refusal or inability to understand consent.
  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): NCT03181464


Contacts
Contact: Yehuda Ginosar, MBBS (314) 362-2264 ginosary@wustl.edu
Contact: Allison Mitchell, MD 314-294-5711 mitchela@wustl.edu

Locations
United States, Missouri
Washington University in St Louis School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Yehuda Ginosar, MBBS    314-362-2264    ginasary@wustl.edu   
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Yehuda Ginosar, MBBS WUDA, Washington University School of Medicine
  More Information

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03181464     History of Changes
Other Study ID Numbers: 201703055
First Submitted: June 5, 2017
First Posted: June 8, 2017
Last Update Posted: July 31, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Headache
Wounds and Injuries
Post-Dural Puncture Headache
Cerebrospinal Fluid Leak
Cerebrospinal Fluid Rhinorrhea
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
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