Sphenopalatine Ganglion Nerve Block for Postdural Puncture Headache in Obstetrics

ID: NCT03181464
Status: Recruiting
Phase: Phase 4
Start Date: June 15, 2018
First Submitted: June 05, 2017
Last Updated: February 08, 2018
Results: N/A
Sponsors & Collaborators: Washington University School of Medicine
Location: United States
Conditions: Postdural Puncture Headache, Cerebrospinal Fluid Leak, Spinal; Puncture, Complications, Headache
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Study Description

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.

Detailed Description

Condition or disease Intervention/treatment Phase

Cerebrospinal Fluid Leak

Postdural Puncture Headache

Spinal; Puncture, Complications, Headache

Drug: Lidocaine 4%
Other Names
Xylocaine
Drug: Placebo
Other Names
saline
Phase 4

Tracking Information

First Submitted DateJune 05, 2017
Last Update Posted DateFebruary 08, 2018
Anticipated Start DateJune 15, 2018
Anticipated Completion DateMay 01, 2019
Anticipated Primary Completion DateDecember 01, 2018
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Subject-reported analgesia [Time Frame: 1 hour after infusion]

    Number of subjects reporting resolution of headache

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Subject-reported lack of effectiveness [Time Frame: 1 hour after infusion]

    Number of subjects reporting no impact of treatment on headache and requesting blood patch

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleSphenopalatine Ganglion Nerve Block for Postdural Puncture Headache in Obstetrics
Official TitleSphenopalatine Ganglion Nerve Block for Postdural Puncture Headache in Obstetrics
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.

Detailed Description

Study TypeInterventional
Study PhasePhase 4
Estimated Enrollment
50
Allocation
Randomized
Interventional Model
Crossover Assignment
Masking
Double
Primary Purpose
Treatment
Conditions
Cerebrospinal Fluid Leak
Postdural Puncture Headache
Spinal; Puncture, Complications, Headache
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: Lidocaine 4%

lidocaine solution

Other Names
Xylocaine
Drug: Placebo

saline .9% injection

Other Names
saline
Study Groups/Cohorts
experimental - lidocaine 4%
Continuous infusion lidocaine at 3ml/hr for 1 hour bilaterally onto the posterior wall of the nasopharynx.

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

Study Arms
Experimental experimental - lidocaine 4%
Continuous infusion lidocaine at 3ml/hr for 1 hour bilaterally onto the posterior wall of the nasopharynx.
Drug : Lidocaine 4%
lidocaine solution

Placebo Comparator placebo comparator
Continuous infusion saline at 3ml/hr for 1 hour bilaterally onto the posterior wall of the nasopharynx
Drug : Placebo
saline .9% injection

Arm Intervention/Treatment
Experimental experimental - lidocaine 4%
Continuous infusion lidocaine at 3ml/hr for 1 hour bilaterally onto the posterior wall of the nasopharynx.
Drug : Lidocaine 4%
Placebo Comparator placebo comparator
Continuous infusion saline at 3ml/hr for 1 hour bilaterally onto the posterior wall of the nasopharynx
Drug : Placebo

Recruitment Information

Recruitment Status:Recruiting
Enrollment50
Completion DateMay 01, 2019
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.
GenderFemale
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
United States

Administrative Information

NCT Number:NCT03181464
Other Study ID Numbers
201703055
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Washington University School of Medicine
Collaborators
Not Available
Investigators
Principal Investigator
Yehuda Ginosar, MBBS
WUDA, Washington University School of Medicine