MedTrace Logo

Sphenopalatine Nerve Block for Headache Tx360

NCT01939314 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2015-07-27

Study results available
· View outcomes & findings →

Summary

The primary objective of this study is to evaluate the efficacy of sphenopalatine nerve block utilizing the Tx360 (device) to deliver an anesthetic agent (bupivacaine) and to assess the duration of the analgesia.

Conditions

Interventions

DRUG

Bupivacaine

Bupivavaine Delivered by the Tx 360 Device to the Sphenopalatine Ganglion

DRUG

Placebo

Normal Saline Delivered by the Tx 360 Device to the Sphenopalatine Ganglion

Sponsors & Collaborators

  • Indiana University

    lead OTHER

Principal Investigators

  • Jason T Schaffer, MD · Indiana University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01939314 on ClinicalTrials.gov