NCT03181464: SNoB

Sphenopalatine Ganglion Nerve Block for Postdural Puncture Headache in Obstetrics

Withdrawn Phase 4 Last updated 12 February 2019

What this trial tests

Phase 4 trial testing Lidocaine 4% in Postdural Puncture Headache. Withdrawn.

Timeline

17 April 2018

Primary endpoint
30 January 2019

30 January 2019

Quick facts

Lead sponsor	Washington University School of Medicine
Phase	Phase 4
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Start date	17 April 2018
Primary completion	30 January 2019
Estimated completion	30 January 2019
Sites	1 location across United States

Drugs / interventions tested

• Lidocaine 4% — full drug profile →
• Placebo

Conditions studied

• Postdural Puncture Headache — all drugs for Postdural Puncture Headache →
• Cerebrospinal Fluid Leak — all drugs for Cerebrospinal Fluid Leak →
• Spinal; Puncture, Complications, Headache — all drugs for Spinal; Puncture, Complications, Headache →

Sponsor

Washington University School of Medicine

Who can join

18 and older, female only, with Postdural Puncture Headache or Cerebrospinal Fluid Leak. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.