Sphenopalatine Ganglion Nerve Block for Postdural Puncture Headache in Obstetrics

Brief Title

Sphenopalatine Ganglion Nerve Block for Postdural Puncture Headache in Obstetrics

Official Title

Sphenopalatine Ganglion Nerve Block for Postdural Puncture Headache in Obstetrics

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.
    


Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Subject-reported analgesia

Secondary Outcome

 Subject-reported lack of effectiveness

Condition

Postdural Puncture Headache

Intervention

Lidocaine 4%

Study Arms / Comparison Groups

 experimental - lidocaine 4%
Description:  Continuous infusion lidocaine at 3ml/hr for 1 hour bilaterally onto the posterior wall of the nasopharynx.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

0

Start Date

April 17, 2018

Completion Date

January 30, 2019

Primary Completion Date

January 30, 2019

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.
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Yehuda Ginosar, MBBS, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03181464

Organization ID

201703055


Responsible Party

Sponsor

Study Sponsor

Washington University School of Medicine


Study Sponsor

Yehuda Ginosar, MBBS, Principal Investigator, WUDA, Washington University School of Medicine


Verification Date

February 2019