Ultrasound Guided Trigeminal Nerve Block for Typical or Atypical Facial Pain

June 14, 2017 updated by: Antoun Nader, Northwestern University

Phase 4 Study Comparing of Dexamethasone to Triamcinolone for Ultrasound-guided Trigeminal Nerve Block: A Randomized Controlled Trial.

Trigeminal neuralgia is a craniofacial pain syndrome that is typically characterized by unilateral severe, recurrent, electrical pain in one or more distributions of the trigeminal nerve. Current treatment strategies include oral medications as first line therapy with surgical interventions reserved for those patients who are refractory to medications or unable to tolerate medication side effects. Despite these current treatment options, many patients continue to have symptoms. Ultrasound-guided trigeminal nerve block allows for fine adjustment of the needle tip and direct observation of the medicine.

Local anesthetic and steroids have been successfully used for diagnostic and or therapeutic nerve pain with great success. Steroids can be short or long acting in duration with varying side effects. If there exists a difference in duration of action, using the longer acting drug will provide a greater period of symptom relief for the patient and may allow the patient to undergo fewer interventional procedures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Anesthesiology Pain Medcine Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients presenting to the Northwestern Pain Center who are eligible and scheduled to receive a ultrasound-guided trigeminal nerve block.

Exclusion Criteria:

  • Exclusion is the same for patients who are not eligible for ultrasound guided nerve blocks.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dexamethasone
4 mg of Dexamethasone and 4 mL of 0.25% bupivacaine
Drug: Bupivacaine
4 mL of 0.25% bupivacaine
Drug: Dexamethasone
4 mg of Dexamethasone
Active Comparator: Triamcinolone
40 mg of Triamcinolone and 4 mL of 0.25% bupivacaine
Drug: Bupivacaine
4 mL of 0.25% bupivacaine
Drug: Triamcinolone
40 mg of Triamcinolone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Proportion of Subjects Reporting at Least 50% Overall Pain Relief
Time Frame: 2 weeks
The number of subjects reporting a minimum of 50% pain relief after receiving the injection.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Investigators

  • Principal Investigator: Antoun Nader, MD, Northwestern University Feinberg School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

December 27, 2013

First Submitted That Met QC Criteria

December 27, 2013

First Posted (Estimate)

December 31, 2013

Study Record Updates

Last Update Posted (Actual)

July 11, 2017

Last Update Submitted That Met QC Criteria

June 14, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00083918 (Other Identifier: Institutional Review Board (IRB))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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