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

NCT ID: NCT02365909

Last Updated: 2017-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

EARLY_PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-29

Study Completion Date

2016-08-30

Brief Summary

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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.

Detailed Description

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Conditions

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Postdural Puncture Headache

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Acitve

This group will receive 0.3 ml of 0.5% bupivacaine per nare, applied with the Tx360®

Group Type ACTIVE_COMPARATOR

0.5% bupivacaine

Intervention Type DRUG

This group will receive 0.3 ml of 0.5% bupivacaine per nare, applied with the Tx360®

Placebo

This group will receive 0.3 ml of normal saline per nare, applied with the Tx360®

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type DRUG

This group will receive 0.3 ml of normal saline per nare, applied with the Tx360®

Interventions

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0.5% bupivacaine

This group will receive 0.3 ml of 0.5% bupivacaine per nare, applied with the Tx360®

Intervention Type DRUG

normal saline

This group will receive 0.3 ml of normal saline per nare, applied with the Tx360®

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Arkansas

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

Countries

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United States

Other Identifiers

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203684

Identifier Type: -

Identifier Source: org_study_id