Expired Study
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Little Rock, Arkansas 72205


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.


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)


Study is Available At:


Original ID:

203684


NCT ID:

NCT02365909


Secondary ID:


Study Acronym:

PDPH


Brief Title:

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


Official Title:

A Prospective Randomized Double-Blind Placebo Controlled Study Evaluating Sphenopalatine Ganglion Block (SPGB) for Treatment of Postdural Puncture Headache (PDPH)


Overall Status:

Terminated


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Arkansas


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

Study stopped due to difficulty recruiting p


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

6


Enrollment Type:

Actual


Study Dates

Start Date:June 29, 2015
Completion Date:August 30, 2016
Completion Type:Actual
Primary Completion Date:August 30, 2016
Primary Completion Type:Actual
Verification Date:September 2017
Last Changed Date:September 15, 2017
First Received Date:February 11, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Headache verbal pain score
Time Frame:1 hour
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:0.5% bupivacaine
Description:This group will receive 0.3 ml of 0.5% bupivacaine per nare, applied with the Tx360®
Arm Name:Acitve
Intervention Type:Drug
Name:normal saline
Description:This group will receive 0.3 ml of normal saline per nare, applied with the Tx360®
Arm Name:Placebo

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Placebo
Description:This group will receive 0.3 ml of normal saline per nare, applied with the Tx360®
Study Arm Type:Active Comparator
Arm Name:Acitve
Description:This group will receive 0.3 ml of 0.5% bupivacaine per nare, applied with the Tx360®

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Arkansas

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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