The Sphenopalatine Ganglion Block for Post-dural Puncture Headache

NCT03385772 | Unknown

• 1 other identifier: 2017P002523
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Post-Dural Puncture Headache

Keywords

sphenopalatine block

Outcome Measures

Primary Outcomes (1)

• Change in VAS scores for headache at 4 hours after the sphenopalatine ganglion block.

  measured VAS for headache

  4 h post-intervention

Secondary Outcomes (4)

• Time to first request of medication for symptom control after the sphenopalatine ganglion block,

  24 h

• Need for blood patch

  24 h

• Presence of nausea, neck pain, visual changes post-intervention

  periodic questioning over 24h

• Symptomatic relief of headache after the block

  24 h

Interventions

Sphenopalatine ganglion block PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: The study is on postpartum women with post dural puncture headache after neuraxial anesthesia for delivery.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Related Publications (2)

• 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.

  PMID: 27687372 BACKGROUND

• 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.

  PMID: 28416992 BACKGROUND

MeSH Terms

Conditions

Post-Dural Puncture Headache

Interventions

Sphenopalatine Ganglion Block

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Autonomic Nerve Block; Nerve Block; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Mihaela Podovei, MD

CONTACT

6176715012; mpodovei@bwh.harvard.edu

Jessica Wrobel, MD

CONTACT

jwrobel@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor, Harvard Medical School, Staff Anesthesiologist, Department of Anesthesia

Model Details: 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.

Study Record Dates

• First Submitted: December 21, 2017
• First Posted: December 28, 2017
• Study Start: January 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: April 1, 2019
• Last Updated: December 28, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share