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RCT of SPG Blocks for Post-dural Headache

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03560349
Recruitment Status : Enrolling by invitation
First Posted : June 18, 2018
Last Update Posted : August 11, 2020
Sponsor:
Collaborators:
University of Colorado, Denver
University of California, San Francisco
Duke University
Mayo Clinic
Harvard University
Information provided by (Responsible Party):
University of Utah

Brief Summary:
The purpose of the study is to assess the effectiveness of the SPG block with lidocaine vs. SPG block with placebo on preventing the need for EBP in women who develop PDPH after accidental dural puncture during placement of LEA for labor.

Condition or disease Intervention/treatment Phase
Post-Dural Puncture Headache Drug: Lidocaine HCl Gel 2% Drug: placebo gel Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: A Multicenter Double Blinded Randomized Controlled Trial of the Efficacy of the Sphenopalatine Ganglion Block for the Treatment of the Postdural Puncture Headache After Labor Epidural
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arm Intervention/treatment
Experimental: Lidocaine
Transnasal blockade of SPG approach involving the application of 2 cc (approximately the size of a pea) of 2% lidocaine jelly on a cotton swab directed posteriorly towards the SPG in the nasal passage bilaterally. Cotton swab will be inserted to the back of the nasal passage until it can no longer be inserted any further. The cotton swab should remain in place for 15 minutes on both sides simultaneously. The patient will be instructed on how to perform this procedure on themselves, and they will be given supplies for a 7-day supply of medication to be administered two times per day at approximately 12 hour intervals.
Drug: Lidocaine HCl Gel 2%

Patients will be prescribed a regimen of 1 g acetaminophen q 8hrs alternating with 600 mg ibuprofen q 6 hours. In addition they will be instructed to continue oral fluid hydration and minimal activity for 24 hours.

At 2-hours following the SPG blockade an EBP will be offered to patients. Patient will also be informed that they can request an EBP at any time. The SPG blockade will be performed twice daily in the hospital and twice daily at home, by the patient. The patient will also be informed, if that at anytime, they would like an EBP, it can be provided.

While the study is being conducted, patients will not be offered a SPG block unless enrolled in the study.


Placebo Comparator: Placebo
Transnasal blockade of SPG approach involving the application of 2 cc (approximately the size of a pea) of nasal saline jelly on a cotton swab directed posteriorly towards the SPG in the nasal passage bilaterally. Cotton swab will be inserted to the back of the nasal passage until it can no longer be inserted any further. The cotton swab should remain in place for 15 minutes. The patient will be instructed on how to perform this procedure on themselves, and they will be given supplies for a 7-day supply of medication to be administered up to two times per day at approximately 12 hour intervals.
Drug: placebo gel

Patients will be prescribed a regimen of 1 g acetaminophen q 8hrs alternating with 600 mg ibuprofen q 6 hours. In addition they will be instructed to continue oral fluid hydration and minimal activity for 24 hours.

At 2-hours following the SPG blockade an EBP will be offered to patients. Patient will also be informed that they can request an EBP at any time. The SPG blockade will be performed twice daily in the hospital and twice daily at home, by the patient. The patient will also be informed, if that at anytime, they would like an EBP, it can be provided.

While the study is being conducted, patients will not be offered a SPG block unless enrolled in the study.





Primary Outcome Measures :
  1. Epidural Blood Patch [ Time Frame: 7 days after treatment with lidocaine or placebo block ]
    Proportion of postpartum women with a postdural puncture headache (PDPH) requesting epidural blood patch (EBP)


Secondary Outcome Measures :
  1. Verbal Numerical Pain [ Time Frame: 30 minutes, 1 hour, 2, hour, 1 day, 2, days, 3 days, 4 days, 5 days, 6 days, and 7 days after treatment with lidocaine or placebo block ]
    Verbal Numerical Pain score (0-10)

  2. Verbal Functionality Score [ Time Frame: 1 day, 2, days, 3 days, 4 days, 5 days, 6 days, and 7 days after treatment with lidocaine or placebo block ]
    Daily Questionnaire regarding functionality



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Studying post partum women
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Females
  • age 18-50
  • Post Dural Puncture Headache after documented accidental dural puncture during placement of LEA for labor and no better explanation for headache
  • onset of HA within 72 hours of delivery.

Exclusion Criteria:

  • true allergy to local anesthesia
  • Hereditary Hemorrhagic Telangiectasia
  • inability to understand pain scores and other questionnaires
  • inability to speak English
  • contraindication to acetaminophen or NSAIDs
  • temperature >38.5 C
  • prior Epidural Blood Patch done for this headache

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03560349


Locations
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United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
University of Colorado, Denver
University of California, San Francisco
Duke University
Mayo Clinic
Harvard University
Publications:

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Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT03560349    
Other Study ID Numbers: 110257
First Posted: June 18, 2018    Key Record Dates
Last Update Posted: August 11, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Post-Dural Puncture Headache
Headache
Pain
Neurologic Manifestations
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action