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

Primary Purpose

Postdural Puncture Headache

Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
0.5% bupivacaine
normal saline
Sponsored by
University of Arkansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postdural Puncture Headache

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • University of Arkansas for Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Acitve

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Headache verbal pain score

Secondary Outcome Measures

Full Information

First Posted
February 11, 2015
Last Updated
September 15, 2017
Sponsor
University of Arkansas
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1. Study Identification

Unique Protocol Identification Number
NCT02365909
Brief Title
Study Evaluating Sphenopalatine Ganglion Block (SPGB) for Treatment of Postdural Puncture Headache (PDPH)
Acronym
PDPH
Official Title
A Prospective Randomized Double-Blind Placebo Controlled Study Evaluating Sphenopalatine Ganglion Block (SPGB) for Treatment of Postdural Puncture Headache (PDPH)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Terminated
Why Stopped
Study stopped due to difficulty recruiting patients
Study Start Date
June 29, 2015 (Actual)
Primary Completion Date
August 30, 2016 (Actual)
Study Completion Date
August 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postdural Puncture Headache

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acitve
Arm Type
Active Comparator
Arm Description
This group will receive 0.3 ml of 0.5% bupivacaine per nare, applied with the Tx360®
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
This group will receive 0.3 ml of normal saline per nare, applied with the Tx360®
Intervention Type
Drug
Intervention Name(s)
0.5% bupivacaine
Intervention Description
This group will receive 0.3 ml of 0.5% bupivacaine per nare, applied with the Tx360®
Intervention Type
Drug
Intervention Name(s)
normal saline
Intervention Description
This group will receive 0.3 ml of normal saline per nare, applied with the Tx360®
Primary Outcome Measure Information:
Title
Headache verbal pain score
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States

12. IPD Sharing Statement

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

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