Ignite Creation Date:
2024-05-06 @ 10:11 AM
Last Modification Date:
2024-10-26 @ 12:25 PM
Study NCT ID:
NCT03181464
Status:
WITHDRAWN
Last Update Posted:
2019-02-12
First Post:
2017-06-05
Brief Title:
Sphenopalatine Ganglion Nerve Block for Postdural Puncture Headache in Obstetrics
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
Sphenopalatine Ganglion Nerve Block for Postdural Puncture Headache in Obstetrics
Status:
WITHDRAWN
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to recruit participants
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SNoB
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 andor 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 patients 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
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 andor 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 patients 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None