Sphenopalatine Ganglion Nerve Block for Postdural Puncture Headache in Obstetrics

NCT ID: NCT03181464

Last Updated: 2019-02-12

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-17
• Study Completion Date: 2019-01-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

experimental - lidocaine 4%

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

Group Type: EXPERIMENTAL

Lidocaine 4%

Intervention Type: DRUG

lidocaine solution

placebo comparator

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

saline .9% injection

Interventions

Lidocaine 4%

lidocaine solution

Intervention Type: DRUG

Placebo

saline .9% injection

Intervention Type: DRUG

Other Intervention Names

Xylocaine; saline

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yehuda Ginosar, MBBS

Role: PRINCIPAL_INVESTIGATOR

WUDA, Washington University School of Medicine

Locations

Washington University in St Louis School of Medicine

St Louis, Missouri, United States

Countries

United States

Other Identifiers

201703055

Identifier Type: -

Identifier Source: org_study_id