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

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. Read our disclaimer for details. Identifier: NCT03181464
Recruitment Status : Withdrawn (Unable to recruit participants)
First Posted : June 8, 2017
Last Update Posted : February 12, 2019
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:

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 or disease Intervention/treatment Phase
Postdural Puncture Headache Cerebrospinal Fluid Leak Spinal; Puncture, Complications, Headache Drug: Lidocaine 4% Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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
Actual Study Start Date : April 17, 2018
Actual Primary Completion Date : January 30, 2019
Actual Study Completion Date : January 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arm Intervention/treatment
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

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

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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.

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 identifier (NCT number): NCT03181464

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United States, Missouri
Washington University in St Louis School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
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Principal Investigator: Yehuda Ginosar, MBBS WUDA, Washington University School of Medicine
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Responsible Party: Washington University School of Medicine Identifier: NCT03181464    
Other Study ID Numbers: 201703055
First Posted: June 8, 2017    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Post-Dural Puncture Headache
Cerebrospinal Fluid Leak
Wounds and Injuries
Neurologic Manifestations
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Anesthetics, Local
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