MedDataX Logo

Sphenopalatine Ganglion Block for Post-Dural Puncture Headache

NCT ID: NCT02181205

Last Updated: 2017-11-08

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postdural Puncture Headache Sphenopalatine Ganglion Block

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

placebo

sphenopalatine ganglion block performed with normal saline as the placebo

Group Type EXPERIMENTAL

placebo

Intervention Type DRUG

bupivacaine

sphenopalatine ganglion block performed with bupivacaine

Group Type ACTIVE_COMPARATOR

bupivacaine

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

bupivacaine

Intervention Type DRUG

placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Peter H Pan, MD, MSEE

Role: PRINCIPAL_INVESTIGATOR

Wake Forest School of Medicine-Anesthesiology

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Novant Health Forsyth Medical Center

Winston-Salem, North Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

14-024

Identifier Type: -

Identifier Source: org_study_id