NCT02181205

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 3, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
Last Updated

November 8, 2017

Status Verified

February 1, 2017

Enrollment Period

2.2 years

First QC Date

July 1, 2014

Last Update Submit

November 6, 2017

Conditions

Postdural Puncture HeadacheSphenopalatine Ganglion Block

Outcome Measures

Primary Outcomes (1)

  • verbal pain score

    a reduction in headache verbal pain score by 3

    1 hour

Secondary Outcomes (4)

  • epidural blood patch

    7 days

  • patient satisfaction

    1 hour

  • pain score

    30 minutes

  • pain score

    7 days

Study Arms (2)

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

bupivacaineDRUG
bupivacaine
placeboDRUG
placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • allergy to study medications \<18 years of age pain score on presentation \</=3/10 for headache

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novant Health Forsyth Medical Center

Winston-Salem, North Carolina, 27103, United States

Location

MeSH Terms

Conditions

Post-Dural Puncture Headache

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Peter H Pan, MD, MSEE

    Wake Forest School of Medicine-Anesthesiology

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2014

First Posted

July 3, 2014

Study Start

November 1, 2014

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

November 8, 2017

Record last verified: 2017-02

Locations

US(1)