There is a brand new study on treatment of Post-Dural Puncture Headaches utilizing Sphenopalatine Ganglion Blocks being sponsored by Brigham and Women’s Hospital.

Previous studies have shown success with SPG Blocks on Post-Dural Puncture Headaches.

The study is utilizing cotton tipped nasal applicators similar to what I use for teaching patients to self-administer SPG Blocks.  I prefer the nasal catheters that have continual capillary feed and usually leave them in for a minimum of 20 minutes but often for much longer periods of time.

The link to study information is on ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT03385772

Febuary 2, 2018 update:   Ropivacaine use in transnasal sphenopalatine ganglion block for post dural puncture headache in obstetric patients -case series. This is a new study (abstract below) just published in Brazil.   Rev Bras Anestesiol. 2018 Feb 2. pii: S0034-7094(17)30134-4. doi: 10.1016/j.bjan.2017.11.007.

The conclusion was “The average duration of analgesic effect of the block remains poorly defined. In the cases reported, blocking with ropivacaine was a simple, safe and effective technique, with immediate and sustained pain relief for at least 12-24h.”

****There are several additional studies on this same topic at ClinicalTrials.gov. ***

Sphenoaplatine Ganglion Block Versus Occipital Nerve Block in Treatment of Post Dural Headache (PDPH)

https://clinicaltrials.gov/ct2/show/NCT03156049?cond=sphenopalatine+ganglion+blocks&rank=6

Sphenopalatine Ganglion Block for Postdural Puncture Headache in the Emergency Department.

https://clinicaltrials.gov/ct2/show/NCT02517931?cond=sphenopalatine+ganglion+blocks&rank=7

Treatment of Post-Dural Puncture Headache in Postpartum Patient:  Sphenopalatine Ganglion Block to Epidural Blood Patch

https://clinicaltrials.gov/ct2/show/NCT02962427?cond=sphenopalatine+ganglion+blocks&rank=11

Sphenopalatine Ganglion Nerve Block for Postdural Puncture Headache in Obstetrics (SNoB)     Therapeutic Epidural Patch Versus Pain Block in the Midface for Headache

https://clinicaltrials.gov/ct2/show/NCT03112720?cond=sphenopalatine+ganglion+blocks&rank=21

 

There are patient videos on SPG Blocks at:

The link to study information is on ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT03385772
This information is copied below;
The Sphenopalatine Ganglion Block for Post-dural Puncture 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03385772
Recruitment Status : Not yet recruiting
First Posted : December 28, 2017
Last Update Posted : December 28, 2017
See Contacts and Locations
Sponsor:
Brigham and Women’s Hospital
Information provided by (Responsible Party):
Mihaela Podovei, Brigham and Women’s Hospital

Study Details Tabular ViewNo Results PostedDisclaimerHow to Read a Study Record
Study Description
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Brief Summary:
This study aims to determine the efficacy of the sphenopalatine ganglion block in the treatment of post-dural puncture headache in post-partum women at the Brigham and Women’s Hospital by measuring VAS scores at times between 0 and 24 hours after the block. We hypothesize that there will be at least a 50% reduction in VAS scores at 4 hours after performing the sphenopalatine block as compared to baseline VAS scores.

Condition or disease Intervention/treatment
Post-Dural Puncture Headache
Procedure: Sphenopalatine ganglion block

Detailed Description:
Post-dural puncture headache (PDPH) is a major cause of morbidity in postpartum patients who received neuraxial anesthesia for labor analgesia or cesarean delivery. The headache in PDPH is thought to be due to loss of cerebrospinal fluid causing downward traction on the meninges with parasympathetic ally mediated reflex vasodilation of the meningeal vessels. The epidural blood patch is currently the gold-standard treatment for postdural puncture headache, however it is an invasive procedure with possible risks and complications including bleeding, infection, pain, hematoma, neurologic complications, and repeat dural puncture. Patients are often offered conservative treatment including medications, bed rest, abdominal binders, and fluids for at least 24 hours prior to being offered an epidural blood patch. Once the decision is made to proceed with a blood patch, it may take several hours before the procedure is performed due to staffing issues. We propose that the sphenopalatine ganglion block, a relatively noninvasive procedure which has been used by neurologists as a treatment for a variety of types of headaches, may play a role in the treatment of postdural puncture headache in the obstetric population.The sphenopalatine ganglion is a parasympathetic ganglion located in the pterygopalatine fossa which can be accessed topically through the nose. The proposed mechanism of the sphenopalatine ganglion block is parasympathetic blockade preventing the profound vasodilation associated with the headache after a dural puncture, thus providing the patient with symptomatic relief. While the sphenopalatine ganglion block has been used by neurologists for the treatment of migraines and cluster headaches for years, little is known about its effectiveness in the treatment of post-dural puncture headache in post-partum women. A small case series by Kent et al demonstrated that offering the sphenopalatine ganglion block as a first-line treatment for post-dural puncture headache provided symptomatic relief and reduced the need for epidural blood patch. If the sphenopalatine ganglion block is found to be an effective treatment for post-dural puncture headache in the obstetric population, the block could be offered to patients as a firstline treatment as a way to improve VAS scores, reduce the need for medications with potential side effects, and possibly reduce the need for epidural blood patch.The primary outcome will be change in VAS scores at 4 hours after the sphenopalatine ganglion block. Secondary outcomes will include time to first Fioricet dose after the sphenopalatine ganglion block, presence of nausea at 4 hours, presence of neck pain at 4 hours, presence of visual changes at 4 hours, change in VAS scores at 12 hours, change in VAS scores at 24 hours, and need for epidural blood patch.

Study Design
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Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: This is a prospective interventional pilot study of the efficacy of the sphenopalatine ganglion block for treatment of post-dural puncture headache in post-partum women.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Sphenopalatine Ganglion Block as a Treatment Modality for Post-dural Puncture Headache in the Post-partum Patient
Anticipated Study Start Date : January 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : April 2019
Resource links provided by the National Library of Medicine
MedlinePlus related topics: Headache
U.S. FDA Resources

Arms and Interventions
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Intervention Details:
Procedure: Sphenopalatine ganglion block
The patient will be placed supine, with head in sniffing position. Two long cotton-tipped applicators will be soaked in 4% lidocaine for 30 seconds. An anesthesia provider, after visually inspecting each nostril for any sign of deformity or blockage, will perform the block. A cotton tipped applicator will be inserted into one nostril at an angle perpendicular to the face, and will be advanced to the back of the nasopharynx until resistance is met. The procedure will be repeated in the other nostril. If the patient experiences any pain or discomfort, the physician will stop and redirect the applicator. The applicators will be left in place for 10 minutes, and then removed by the anesthesia provider.

Outcome Measures
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Primary Outcome Measures :
Change in VAS scores for headache at 4 hours after the sphenopalatine ganglion block. [ Time Frame: 4 h post-intervention ] measured VAS for headache

Secondary Outcome Measures :
Time to first request of medication for symptom control after the sphenopalatine ganglion block, [ Time Frame: 24 h ] Need for blood patch [ Time Frame: 24 h ] performance of epidural blood patch for treatment of PDPH

Presence of nausea, neck pain, visual changes post-intervention [ Time Frame: periodic questioning over 24h ] yes/no questions

Symptomatic relief of headache after the block [ Time Frame: 24 h ] VAS scores at different time points via pain diaries

Eligibility Criteria
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Information from the National Library of Medicine
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, Learn About Clinical Studies.

Ages Eligible for Study: 18 Years to 50 Years (Adult)
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: The study is on postpartum women with post dural puncture headache after neuraxial anesthesia for delivery.
Accepts Healthy Volunteers: Yes
Criteria
Inclusion Criteria:

All postpartum women aged 18-50 who received neuraxial anesthesia for labor or cesarean delivery and are diagnosed with a post-dural puncture headache within 72 hours post-partum will be eligible to participate.
Exclusion Criteria:

Patients with a history of migraines, chronic headaches, chronic narcotic use, chronic neurological disorder, bleeding disorder, deformity of nasal septum, allergy to local anesthetics, nasal polyps, frequent nosebleeds, those with a diagnosis of pregnancy induced hypertension or pre-eclampsia in the most recent pregnancy, and those with nasal or sinus surgery within the past year will be ineligible to participate.
Contacts and Locations
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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): NCT03385772

Contacts
Contact: Mihaela Podovei, MD 6176715012 [email protected]
Contact: Jessica Wrobel, MD [email protected]

Sponsors and Collaborators
Brigham and Women’s Hospital
More Information
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Publications:
Kent S, Mehaffey G. Transnasal sphenopalatine ganglion block for the treatment of postdural puncture headache in obstetric patients. J Clin Anesth. 2016 Nov;34:194-6. doi: 10.1016/j.jclinane.2016.04.009. Epub 2016 May 11.
Nair AS, Rayani BK. Sphenopalatine ganglion block for relieving postdural puncture headache: technique and mechanism of action of block with a narrative review of efficacy. Korean J Pain. 2017 Apr;30(2):93-97. doi: 10.3344/kjp.2017.30.2.93. Epub 2017 Mar 31. Review.

Responsible Party: Mihaela Podovei, Instructor, Harvard Medical School, Staff Anesthesiologist, Department of Anesthesia, Brigham and Women’s Hospital
ClinicalTrials.gov Identifier: NCT03385772 History of Changes
Other Study ID Numbers: 2017P002523
First Posted: December 28, 2017 Key Record Dates
Last Update Posted: December 28, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All data obtained during this study, both clinical and other data including pain diaries, will be kept confidential. Participants will be de-identified using codes so that the names of the study participants will be known only to the study investigators. No information about the identity of individual subjects will be used for publication. The pain diaries and consent forms will be kept in a locked file cabinet. All study data will be kept on a password-protected computer and only the research investigators will have access to the database.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mihaela Podovei, Brigham and Women’s Hospital:
sphenopalatine block

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

 

pubmed abstract below:

Rev Bras Anestesiol. 2018 Feb 2. pii: S0034-7094(17)30134-4. doi: 10.1016/j.bjan.2017.11.007. [Epub ahead of print]

[Ropivacaine use in transnasal sphenopalatine ganglion block for post dural puncture headache in obstetric patients – case series].

[Article in Portuguese]

Abstract

PURPOSE:

Sphenopalatine ganglion block is widely accepted in chronic pain; however it has been underestimated in post dural puncture headache treatment. The ganglion block does not restore normal cerebrospinal fluid dynamics but effectively reduces symptoms associated with resultant hypotension. When correctly applied it may avoid performance of epidural blood patch. The transnasal approach is a simple and minimally invasive technique. In the cases presented, we attempted to perform and report the ganglion blockeffectiveness and duration, using ropivacaine.

CLINICAL FEATURES:

We present four obstetrics patients with post dural puncture headache, after epidural or combined techniques, with Tuohy needle 18G that underwent a safe and successful Sphenopalatine ganglion block. We performed the block 24-48h after duralpuncture, with 4mL of ropivacaine 0.75% in each nostril. In three cases pain recurred within 12-48h, although less intense. In one patient a second block was performed with complete relief and without further recurrence. In the other two patients a blood patch was performed without success. All patients were asymptomatic within 7 days.

CONCLUSION:

The average duration of analgesic effect of the block remains poorly defined. In the cases reported, blocking with ropivacaine was a simple, safe and effective technique, with immediate and sustained pain relief for at least 12-24h.

KEYWORDS:

Bloqueio do gânglio esfenopalatino; Cefaleia pós‐punção dural; Cuidados pós‐parto; Postdural puncture headache; Postpartum care; Sphenopalatine ganglion block





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