Sphenopalatine Ganglion Block for Post-Dural Puncture Hea... | NCT02181205

Studies
Sphenopalatine Ganglion Block for Post-Dural Puncture Headache

NCT02181205

Sponsor

Wake Forest University Health Sciences

Status

Withdrawn

Last Update Posted

Nov 8, 2017Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Postdural Puncture Headache
Sphenopalatine Ganglion Block

Interventions

bupivacaine
placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

no eligible participant , technical difficulty, feasiblity

Expanded Access Info

Start Date

Nov 2014

Primary Completion Date

Dec 31, 2016Estimated

Completion Date

Dec 31, 2016Estimated

First Submitted Date

Jul 1, 2014

First Submission Date that Met QC Criteria

Jul 2, 2014

First Posted Date

Jul 3, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 6, 2017

Last Update Posted Date

Nov 8, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
placebo	Experimental	sphenopalatine ganglion block performed with normal saline as the placebo	Drug: placebo
bupivacaine	Active Comparator	sphenopalatine ganglion block performed with bupivacaine	Drug: bupivacaine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
bupivacaine	Drug		bupivacaine
placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
verbal pain score	a reduction in headache verbal pain score by 3	1 hour

Secondary Outcomes

Measure	Description	Time Frame
epidural blood patch	evaluating the decrease in the necessity of an epidural blood patch to treat the postdural puncture headache	7 days
patient satisfaction	patient satisfaction with headache pain relief at 1 hour post treatment

Other Outcomes

Not provided

Eligibility Module

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 \

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter H Pan, MD, MSEE	Wake Forest School of Medicine-Anesthesiology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novant Health Forsyth Medical Center		Winston-Salem	North Carolina	27103	United States

Condition Browse Module

MeSH Terms

ID	Term
D051299	Post-Dural Puncture Headache

Ancestor Terms

ID	Term
D051271	Headache Disorders, Secondary
D020773	Headache Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002045	Bupivacaine

Ancestor Terms

ID	Term
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814	Aniline Compounds

Browse Leaves

Not provided

Browse Branches

Not provided