Back to resultsSphenopalatine Ganglion Block for Post-Dural Puncture Headache
Primary Purpose
Postdural Puncture Headache, Sphenopalatine Ganglion Block
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
bupivacaine
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Postdural Puncture Headache
Eligibility Criteria
Inclusion Criteria:
- American Society of Anesthesiologists assigned class I-III
- age >/= 18 years
- experiencing a postdural puncture headache within 7 days of neuraxial analgesia rated >3/10 pain score
Exclusion Criteria:
- allergy to study medications <18 years of age pain score on presentation </=3/10 for headache
Sites / Locations
- Novant Health Forsyth Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
placebo
bupivacaine
Arm Description
sphenopalatine ganglion block performed with normal saline as the placebo
sphenopalatine ganglion block performed with bupivacaine
Outcomes
Primary Outcome Measures
verbal pain score
a reduction in headache verbal pain score by 3
Secondary Outcome Measures
epidural blood patch
evaluating the decrease in the necessity of an epidural blood patch to treat the postdural puncture headache
patient satisfaction
patient satisfaction with headache pain relief at 1 hour post treatment
pain score
verbal pain score 30 minutes post study treatment
pain score
verbal pain score 7 days post study treatment
Full Information
NCT ID
NCT02181205
First Posted
July 1, 2014
Last Updated
November 6, 2017
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02181205
Brief Title
Sphenopalatine Ganglion Block for Post-Dural Puncture Headache
Official Title
Sphenopalatine Ganglion Block for Treatment of Postdural Puncture Headache: A Prospective Randomized Double Blind Placebo Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Withdrawn
Why Stopped
no eligible participant , technical difficulty, feasiblity
Study Start Date
November 2014 (undefined)
Primary Completion Date
December 31, 2016 (Anticipated)
Study Completion Date
December 31, 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators are attempting to determine a less invasive method of treatment for postdural puncture headaches that can occur after regional anesthesia. The investigators will be evaluating the relief of headache with those subjects receiving treatment with a sphenopalatine ganglion block with bupivacaine versus placebo, evaluating the incidence of epidural blood patch, pain score of headache at 1 hour, then 24, 48, and 72 hours lower with post study treatment versus placebo, and potential side effects of those patients receiving study therapy as well as epidural blood patch.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postdural Puncture Headache, Sphenopalatine Ganglion Block
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
Experimental
Arm Description
sphenopalatine ganglion block performed with normal saline as the placebo
Arm Title
bupivacaine
Arm Type
Active Comparator
Arm Description
sphenopalatine ganglion block performed with bupivacaine
Intervention Type
Drug
Intervention Name(s)
bupivacaine
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
verbal pain score
Description
a reduction in headache verbal pain score by 3
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
epidural blood patch
Description
evaluating the decrease in the necessity of an epidural blood patch to treat the postdural puncture headache
Time Frame
7 days
Title
patient satisfaction
Description
patient satisfaction with headache pain relief at 1 hour post treatment
Time Frame
1 hour
Title
pain score
Description
verbal pain score 30 minutes post study treatment
Time Frame
30 minutes
Title
pain score
Description
verbal pain score 7 days post study treatment
Time Frame
7 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
American Society of Anesthesiologists assigned class I-III
age >/= 18 years
experiencing a postdural puncture headache within 7 days of neuraxial analgesia rated >3/10 pain score
Exclusion Criteria:
allergy to study medications <18 years of age pain score on presentation </=3/10 for headache
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter H Pan, MD, MSEE
Organizational Affiliation
Wake Forest School of Medicine-Anesthesiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Novant Health Forsyth Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Sphenopalatine Ganglion Block for Post-Dural Puncture Headache
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