Sphenopalatine Ganglion Nerve Block for Postdural Puncture Headache in Obstetrics (SNoB)
Primary Purpose
Postdural Puncture Headache, Cerebrospinal Fluid Leak, Spinal; Puncture, Complications, Headache
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Lidocaine 4%
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Postdural Puncture Headache
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.
Sites / Locations
- Washington University in St Louis School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
experimental - lidocaine 4%
placebo comparator
Arm Description
Continuous infusion lidocaine at 3ml/hr for 1 hour bilaterally onto the posterior wall of the nasopharynx.
Continuous infusion saline at 3ml/hr for 1 hour bilaterally onto the posterior wall of the nasopharynx
Outcomes
Primary Outcome Measures
Subject-reported analgesia
Number of subjects reporting resolution of headache
Secondary Outcome Measures
Subject-reported lack of effectiveness
Number of subjects reporting no impact of treatment on headache and requesting blood patch
Full Information
NCT ID
NCT03181464
First Posted
June 5, 2017
Last Updated
February 8, 2019
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03181464
Brief Title
Sphenopalatine Ganglion Nerve Block for Postdural Puncture Headache in Obstetrics
Acronym
SNoB
Official Title
Sphenopalatine Ganglion Nerve Block for Postdural Puncture Headache in Obstetrics
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Unable to recruit participants
Study Start Date
April 17, 2018 (Actual)
Primary Completion Date
January 30, 2019 (Actual)
Study Completion Date
January 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postdural Puncture Headache, Cerebrospinal Fluid Leak, Spinal; Puncture, Complications, Headache
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Model Description
Randomized, double-blind, placebo-controlled cross-over trial
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
experimental - lidocaine 4%
Arm Type
Experimental
Arm Description
Continuous infusion lidocaine at 3ml/hr for 1 hour bilaterally onto the posterior wall of the nasopharynx.
Arm Title
placebo comparator
Arm Type
Placebo Comparator
Arm Description
Continuous infusion saline at 3ml/hr for 1 hour bilaterally onto the posterior wall of the nasopharynx
Intervention Type
Drug
Intervention Name(s)
Lidocaine 4%
Other Intervention Name(s)
Xylocaine
Intervention Description
lidocaine solution
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
saline
Intervention Description
saline .9% injection
Primary Outcome Measure Information:
Title
Subject-reported analgesia
Description
Number of subjects reporting resolution of headache
Time Frame
1 hour after infusion
Secondary Outcome Measure Information:
Title
Subject-reported lack of effectiveness
Description
Number of subjects reporting no impact of treatment on headache and requesting blood patch
Time Frame
1 hour after infusion
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women, 1 day postpartum
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yehuda Ginosar, MBBS
Organizational Affiliation
WUDA, Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University in St Louis School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Sphenopalatine Ganglion Nerve Block for Postdural Puncture Headache in Obstetrics
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