Clinical trial NCT03181464: Sphenopalatine Ganglion Nerve Block for Postdural Puncture Headache in Obstetrics
Official title: Sphenopalatine Ganglion Nerve Block for Postdural Puncture Headache in Obstetrics
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Postdural Puncture Headache
Cerebrospinal Fluid Leak
Spinal; Puncture, Complications, Headache
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2017-06-08
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, double-blind, placebo-controlled cross-over trial
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Subject-reported analgesia
timeFrame: 1 hour after infusion
Secondary outcomes:
measure: Subject-reported lack of effectiveness
timeFrame: 1 hour after infusion
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University in St Louis School of Medicine
state: Missouri
Study officials:
affiliation: WUDA, Washington University School of Medicine
name: Yehuda Ginosar, MBBS
role: PRINCIPAL_INVESTIGATOR
References: