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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03181464
Other study ID # 201703055
Secondary ID
Status Withdrawn
Phase Phase 4
First received
Last updated
Start date April 17, 2018
Est. completion date January 30, 2019

Study information

Verified date February 2019
Source Washington University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date January 30, 2019
Est. primary completion date January 30, 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Lidocaine 4%
lidocaine solution
Placebo
saline .9% injection

Locations

Country Name City State
United States Washington University in St Louis School of Medicine Saint Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Subject-reported analgesia Number of subjects reporting resolution of headache 1 hour after infusion
Secondary Subject-reported lack of effectiveness Number of subjects reporting no impact of treatment on headache and requesting blood patch 1 hour after infusion
See also
  Status Clinical Trial Phase
Terminated NCT03112720 - Therapeutic Epidural Patch Versus Pain Block in the Midface for Headache Phase 3
Suspended NCT02473276 - 2 Dose Neuraxial Morphine for Prevention of PDPH Phase 4
Completed NCT03652714 - The Effect of Ganglion Sphenopalatine Block (GSP-block) Versus Placebo on Postdural Puncture Headache Phase 3
Completed NCT02859233 - Role of Prophylaxis by Oral Fluid Supplementation in Prevention of Postdural Puncture Headache N/A
Withdrawn NCT02181205 - Sphenopalatine Ganglion Block for Post-Dural Puncture Headache N/A
Completed NCT01977898 - Incidence of Headache Following an Unintentional Dural Puncture N/A
Completed NCT06394024 - Examination of Postdural Puncture Headache Frequency, Predisposing Factors and Treatment
Withdrawn NCT03966547 - Changes in Cerebral Blood Flow (CBF) in Prone and Sitting Position Before and After GSP-block and Before and After Epidural Blood-patch: A Substudy of NCT03652714 N/A
Completed NCT06380764 - Greater Occipital Nerve Block Value in Management of Postdural Puncture Headache N/A
Terminated NCT02365909 - Study Evaluating Sphenopalatine Ganglion Block (SPGB) for Treatment of Postdural Puncture Headache (PDPH) Early Phase 1
Completed NCT04910477 - Nebulized Dexmedetomidine Versus Neostigmine/Atropine in Postdural Puncture Headache Phase 3
Completed NCT05969119 - Addition of Pyridostigmine to Conventional Management of Postdural Puncture Headache Phase 4
Completed NCT02150304 - Aminophylline Prophylaxis For Postdural Puncture Headache N/A
Not yet recruiting NCT04709029 - Effect of Intravenous Versus Intrathecal Dexamethazone on Postdural Puncture Headache N/A
Withdrawn NCT02517931 - Sphenopalatine Ganglion Block for Postdural Puncture Headache in the Emergency Department N/A
Recruiting NCT06271486 - Pregabalin in Treatment of Postdural Puncture Headache Phase 3
Completed NCT00465166 - Lumbar Spine Ultrasound of Patients With Previous Accidental Dural Puncture During Labour Epidural N/A
Not yet recruiting NCT05212194 - The Relationship Between Post Dural Puncture Headache and Joint Laxity N/A
Completed NCT05777694 - Postdural Punction Headache After Ceserian Section N/A
Withdrawn NCT04515901 - Spenopalatine Ganglion Block for Treatment of Post-dural Puncture Headaches N/A