Sphenopalatine Ganglion Nerve Block for Postdural Puncture Headache in Obstetrics

NCT03181464 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 201703055
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Postdural Puncture Headache; Cerebrospinal Fluid Leak; Spinal; Puncture, Complications, Headache

Outcome Measures

Primary Outcomes (1)

• Subject-reported analgesia

  Number of subjects reporting resolution of headache

  1 hour after infusion

Secondary Outcomes (1)

• Subject-reported lack of effectiveness

  1 hour after infusion

Study Arms (2)

experimental - lidocaine 4%

EXPERIMENTAL

Continuous infusion lidocaine at 3ml/hr for 1 hour bilaterally onto the posterior wall of the nasopharynx.

Drug: Lidocaine 4%

placebo comparator

PLACEBO COMPARATOR

Continuous infusion saline at 3ml/hr for 1 hour bilaterally onto the posterior wall of the nasopharynx

Drug: Placebo

Interventions

Lidocaine 4% DRUG

lidocaine solution

Also known as: Xylocaine

experimental - lidocaine 4%

Placebo DRUG

saline .9% injection

Also known as: saline

placebo comparator

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women, 1 day postpartum
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University in St Louis School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Post-Dural Puncture Headache; Cerebrospinal Fluid Leak; Headache

Interventions

Lidocaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Craniocerebral Trauma; Trauma, Nervous System; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Pain

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Yehuda Ginosar, MBBS

  WUDA, Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled cross-over trial

Study Record Dates

• First Submitted: June 5, 2017
• First Posted: June 8, 2017
• Study Start: April 17, 2018
• Primary Completion: January 30, 2019
• Study Completion: January 30, 2019
• Last Updated: February 12, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)