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

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.

Study Overview

• Status: Withdrawn
• Conditions: Postdural Puncture Headache; Cerebrospinal Fluid Leak; Spinal; Puncture, Complications, Headache
• Intervention / Treatment: Drug: Lidocaine 4%; Drug: Placebo

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University in St Louis School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject-reported analgesia	Number of subjects reporting resolution of headache	1 hour after infusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject-reported lack of effectiveness	Number of subjects reporting no impact of treatment on headache and requesting blood patch	1 hour after infusion

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Yehuda Ginosar, MBBS, WUDA, Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2018
• Primary Completion (Actual): January 30, 2019
• Study Completion (Actual): January 30, 2019

Study Registration Dates

• First Submitted: June 5, 2017
• First Submitted That Met QC Criteria: June 7, 2017
• First Posted (Actual): June 8, 2017

Study Record Updates

• Last Update Posted (Actual): February 12, 2019
• Last Update Submitted That Met QC Criteria: February 8, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Craniocerebral Trauma; Trauma, Nervous System; Headache Disorders; Headache Disorders, Secondary; Wounds and Injuries; Headache; Post-Dural Puncture Headache; Cerebrospinal Fluid Leak; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 201703055

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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