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Study Evaluating Sphenopalatine Ganglion Block (SPGB) for Treatment of Postdural Puncture Headache (PDPH) (PDPH)

This study has been terminated.
(Study stopped due to difficulty recruiting patients)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02365909
First Posted: February 19, 2015
Last Update Posted: September 18, 2017
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.
Information provided by (Responsible Party):
University of Arkansas
  Purpose
Postdural puncture headaches (PDPH) are a consequence of spinal and epidural anesthesia in approximately 1% of cases when performed in obstetric patients. The gold standard treatment for a PDPH is currently an epidural blood patch (EBP), which involves placing a needle back into the epidural space of the neuraxium and then injecting 20 ml of the patient's own blood through the needle and into the epidural space to form a clot over the insult in the tissue layer that causes the headaches. The investigators want to test the efficacy of using a less invasive procedure, called a sphenopalatine block (SPGB), for treatment of PDPH. SPGB has been used for many years in the treatment of migraines and cluster headaches, and there are several case reports of its use to successfully treat PDPH as well. SPGB simply involves applying a local anesthetic to the mucosa in the back of each nostril to numb the nerves that cause the headache. The investigators hope that the SPGB will reduce the number of PDPH patients that require and EBP.

Condition Intervention Phase
Postdural Puncture Headache Drug: 0.5% bupivacaine Drug: normal saline Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Double-Blind Placebo Controlled Study Evaluating Sphenopalatine Ganglion Block (SPGB) for Treatment of Postdural Puncture Headache (PDPH)

Resource links provided by NLM:


Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • Headache verbal pain score [ Time Frame: 1 hour ]

Enrollment: 6
Actual Study Start Date: June 29, 2015
Study Completion Date: August 30, 2016
Primary Completion Date: August 30, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Acitve
This group will receive 0.3 ml of 0.5% bupivacaine per nare, applied with the Tx360®
Drug: 0.5% bupivacaine
This group will receive 0.3 ml of 0.5% bupivacaine per nare, applied with the Tx360®
Placebo Comparator: Placebo
This group will receive 0.3 ml of normal saline per nare, applied with the Tx360®
Drug: normal saline
This group will receive 0.3 ml of normal saline per nare, applied with the Tx360®

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • Active postdural puncture headache within 7 days after neuraxial analgesia/anesthesia
  • Age ≥ 18 years.
  • ASA physical status ≤ 3

Exclusion Criteria

  • Known coagulopathy
  • Known nasal septal deviation or abnormalities
  • Medical conditions contraindicated to bupivacaine or the nasal applicator (according to the product labeling)
  Contacts and Locations
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): NCT02365909


Locations
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
  More Information

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT02365909     History of Changes
Other Study ID Numbers: 203684
First Submitted: February 11, 2015
First Posted: February 19, 2015
Last Update Posted: September 18, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Headache
Post-Dural Puncture Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents