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Effectiveness of Sphenopalatine Ganglion Block for Post-Dural Puncture Headache

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ClinicalTrials.gov Identifier: NCT03430531
Recruitment Status : Recruiting
First Posted : February 13, 2018
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
Verghese T Cherian, MD, Milton S. Hershey Medical Center

Brief Summary:
The objective of the study is to determine the effectiveness of Spheno-Palatine (SP) ganglion block to alleviate the pain of post-dural puncture headache (PDPH).

Condition or disease Intervention/treatment Phase
Post-Dural Puncture Headache Sphenopalatine Ganglion Block Drug: Lidocaine Phase 2

Detailed Description:

The primary objectives of the study are to study the effectiveness of SP ganglion block in relieving post-dural puncture headache in terms of :

  1. Number of subjects who get relief of pain
  2. The onset time to pain relief after application of block
  3. The duration of pain relief
  4. The incidence of recurrence of post-dural puncture headache

Secondary objectives are to:

  1. Monitor any complications due to SP ganglion block
  2. Measure patient satisfaction
  3. Monitor any residual effects at 1 months after the SP block

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Open-label, single arm, pilot study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Sphenopalatine Ganglion Block for Post-Dural Puncture Headache; A Pilot Study
Actual Study Start Date : May 31, 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arm Intervention/treatment
Experimental: Sphenopalatine ganglion block
Sphenopalatine ganglion block: this block will be performed by inserting swabs, with lidocaine squirted on them, into each nostril and reaching the nasopharyngeal wall.
Drug: Lidocaine
Lidocaine 2% viscous (0.5ml) will be squirted on two cotton swab sticks and one will be gently inserted into each nostril, along the floor of the nose. Slight rotatory motion of the stick will be used to insert it as far as it goes with the intention to reach the nasopharyngeal wall (posterior wall of the nose). At that position the swab sticks will be left undisturbed for 5 minutes. The swabs will be taken out and this will be repeated twice more, using fresh swabs and 0.5ml of 2% lidocaine. The block would take about 30 minutes.




Primary Outcome Measures :
  1. Relief of pain [ Time Frame: 15 minutes before the SP block to 30 days post SP block ]
    Patient reported pain scores will be recorded at the following times and positions: Baseline (before SP block)-supine, baseline-sitting, during SP block, 5 min post SP block-supine, 5 min post SP block-sitting, 60 min post SP block-supine, 60 min post SP block-sitting, and for days 1, 2, 7, 30 days post SP block


Secondary Outcome Measures :
  1. Time to onset of pain relief after application of block [ Time Frame: 15 minutes before the SP block to 30 days post SP block ]
    The time between the performance of the SP block and the time the patient reported pain score decreases from the baseline level.

  2. Duration of pain relief [ Time Frame: 15 minutes before the SP block to 30 days post SP block ]
    Patient reported pain scores, recorded at the times listed for Outcome 1, will be used to determine for how long after the SP block the patient reported pain scores that were decreased form the baseline measures (also describes for Outcome 1).

  3. Incidence of recurrence of post-dural puncture headache [ Time Frame: 15 minutes before the SP block to 30 days post SP block ]
    Patient reported recurrence of post dural puncture headache will be recorded.

  4. Complications due to SP ganglion block [ Time Frame: 15 minutes before the SP block to 30 days post SP block ]
    Patients will be asked to report any side effects, including: allergic reaction to lidocaine, nose irritation and nose-bleed.

  5. Patient satisfaction with SP ganglion block [ Time Frame: 15 minutes before the SP block to 30 days post SP block ]
    Patients will report (yes/no) whether they are satisfied with the management of their headache.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Complains of symptoms suggestive of post-dural puncture headache
  2. Has a history of dural puncture (lumbar puncture or accidental dural puncture during epidural placement) within the previous 7 days
  3. Fluent in written and spoken English

Exclusion Criteria:

  1. Those with a known history of hypersensitivity to local anesthetics of the amide type or to other components of GLYDO
  2. Those with any congenital or acquired, anatomical deformity of the nostril, which preclude performing the block
  3. Those who refuse to consent to participate in the study
  4. Patients who have had a failed epidural blood patch
  5. Cognitive Impairment
  6. Prisoner

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): NCT03430531


Contacts
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Contact: Verghese Cherian, MD 7175316926 vcherian@pennstatehealth.psu.edu
Contact: Abid Kazi, PhD 717-531-0003 ext 282465 akazi@pennstatehealth.psu.edu

Locations
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United States, Pennsylvania
Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Verghese Cherian, MD    717-531-6926    vcherian@pennstatehealth.psu.edu   
Contact: Diane McCloskey, PhD    717-531-0003 ext 280359    dmccloskey@pennstatehealth.psu.edu   
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
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Principal Investigator: Verghese Cherian, MD Milton S. Hershey Medical Center

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Responsible Party: Verghese T Cherian, MD, Associate Professor of Anesthesiology & Perioperative Medicine, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT03430531     History of Changes
Other Study ID Numbers: 8426
First Posted: February 13, 2018    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019

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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
Headache Disorders, Secondary
Headache Disorders
Ganglion Cysts
Synovial Cyst
Pain
Neurologic Manifestations
Signs and Symptoms
Cysts
Neoplasms
Mucinoses
Connective Tissue Diseases
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