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Sphenopalatine Ganglion Block for Postdural Puncture Headache in the Emergency Department

This study is not yet open for participant recruitment.
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Verified September 2016 by University of Arkansas
Sponsor:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT02517931
First received: August 5, 2015
Last updated: September 26, 2016
Last verified: September 2016
  Purpose
This study evaluates sphenopalatine ganglion block (SPGB) for the treatment of postdural puncture headache (PDPH) in the emergency department (ED). Half of the patients will receive a true nerve block with lidocaine and bupivacaine. The other half will receive a placebo nerve block.

Condition Intervention Phase
Postdural Puncture Headache Procedure: Sphenopalatine Ganglion Block Procedure: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Sphenopalatine Ganglion Block for Treatment of Postdural Puncture Headache in the Emergency Department: A Prospective, Randomized, Double-Blind Placebo Controlled Study

Resource links provided by NLM:


Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • Pain level with Verbal Rating Scale [ Time Frame: 5 days ]
    Patients will be asked to self rate their pain with 0 as no pain at all up to 10 being the worst pain imaginable.


Estimated Enrollment: 30
Study Start Date: October 2016
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sphenopalatine Ganglion Block
Subjects will be asked to blow out each nostril. They will then be laid supine with a small shoulder roll and intranasal phenylephrine 0.25% (RhinallⓇ) will be sprayed once into each nostril to preemptively minimize bleeding. Sphenopalatine ganglion block will be performed by inserting long cotton tipped applicators saturated in 2% viscous lidocaine into nostril until properly seated in the posterior nasopharynx. These will be left in place for 10 minutes and then 1 mililiter of 0.5% bupivacaine will be administered down the plastic hollow shaft of each applicator via an 18g angiocatheter. The applicators will remain in place for 10 more minutes and then be removed.
Procedure: Sphenopalatine Ganglion Block
Subjects will be asked to blow out each nostril. They will then be laid supine with a small shoulder roll and intranasal phenylephrine 0.25% (RhinallⓇ) will be sprayed once into each nostril to preemptively minimize bleeding. SPGB will be performed by inserting long cotton tipped applicators saturated in 2% viscous lidocaine into nostril until properly seated in the posterior nasopharynx. These will be left in place for 10 minutes and then 1mL of 0.5% bupivacaine will be administered down the plastic hollow shaft of each applicator via an 18g angiocatheter. The applicators will remain in place for 10 more minutes and then be removed.
Placebo Comparator: Placebo
Subjects will be asked to blow out each nostril. They will then be laid supine with a small shoulder roll and intranasal phenylephrine 0.25% (RhinallⓇ) will be sprayed once into each nostril to preemptively minimize bleeding. SPGB will be performed by inserting long cotton tipped applicators saturated in carboxymethylcellulose based lubricant (i.e. K-Y Jelly®) into nostril until properly seated in the posterior nasopharynx. These will be left in place for 10 minutes and then 1 mililiter of normal saline will be administered down the plastic hollow shaft of each applicator via an 18g angiocatheter. The applicators will remain in place for 10 more minutes and then be removed.
Procedure: Placebo
Subjects will be asked to blow out each nostril. They will then be laid supine with a small shoulder roll and intranasal phenylephrine 0.25% (RhinallⓇ) will be sprayed once into each nostril to preemptively minimize bleeding. SPGB will be performed by inserting long cotton tipped applicators saturated in carboxymethylcellulose based lubricant (i.e. K-Y Jelly®) into nostril until properly seated in the posterior nasopharynx. These will be left in place for 10 minutes and then 1 mililiter of normal saline will be administered down the plastic hollow shaft of each applicator via an 18g angiocatheter. The applicators will remain in place for 10 more minutes and then be removed.

Detailed Description:
Postdural puncture headaches (PDPH) are a common consequence of diagnostic lumbar puncture. The gold standard treatment for a PDPH is currently an autologous epidural blood patch (AEBP), which involves placing a needle into the epidural space of the spine and then injecting 20 ml of the patients own blood through the needle and into the epidural space to form a clot over the tear in the tissue layer that causes the headache. This is an invasive procedure that carries risks of pain, bleeding, infection, and in rare cases, neurological complications. We want to test the efficacy of using a less invasive procedure, called a sphenopalatine ganglion 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. We hope that the SPGB will reduce the number of PDPH patients that require an AEBP.
  Eligibility

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

Inclusion Criteria:

  • Active postdural puncture headache within 7 days after diagnostic lumbar puncture
  • Age ≥ 18 years.
  • American Society of Anesthesiologists (ASA) physical status ≤ 3

Exclusion Criteria:

  • Known coagulopathy
  • Known nasal septal deviation or abnormalities
  • Medical conditions contraindicated to lidocaine or bupivacaine
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT02517931     History of Changes
Other Study ID Numbers: 204502
Study First Received: August 5, 2015
Last Updated: September 26, 2016

Additional relevant MeSH terms:
Emergencies
Headache
Post-Dural Puncture Headache
Disease Attributes
Pathologic Processes
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Phenylephrine
Oxymetazoline
Carboxymethylcellulose Sodium
Cardiotonic Agents
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sympathomimetics
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on September 19, 2017