Ultrasound Guided Trigeminal Nerve Block for Typical or Atypical Facial Pain
Primary Purpose
Typical Facial Pain, Atypical Facial Pain
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine
Triamcinolone
Dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Typical Facial Pain
Eligibility Criteria
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.
Sites / Locations
- Anesthesiology Pain Medcine Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Dexamethasone
Triamcinolone
Arm Description
4 mg of Dexamethasone and 4 mL of 0.25% bupivacaine
40 mg of Triamcinolone and 4 mL of 0.25% bupivacaine
Outcomes
Primary Outcome Measures
The Proportion of Subjects Reporting at Least 50% Overall Pain Relief
The number of subjects reporting a minimum of 50% pain relief after receiving the injection.
Secondary Outcome Measures
Full Information
NCT ID
NCT02024724
First Posted
December 27, 2013
Last Updated
June 14, 2017
Sponsor
Northwestern University
1. Study Identification
Unique Protocol Identification Number
NCT02024724
Brief Title
Ultrasound Guided Trigeminal Nerve Block for Typical or Atypical Facial Pain
Official Title
Phase 4 Study Comparing of Dexamethasone to Triamcinolone for Ultrasound-guided Trigeminal Nerve Block: A Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Typical Facial Pain, Atypical Facial Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dexamethasone
Arm Type
Active Comparator
Arm Description
4 mg of Dexamethasone and 4 mL of 0.25% bupivacaine
Arm Title
Triamcinolone
Arm Type
Active Comparator
Arm Description
40 mg of Triamcinolone and 4 mL of 0.25% bupivacaine
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
4 mL of 0.25% bupivacaine
Intervention Type
Drug
Intervention Name(s)
Triamcinolone
Intervention Description
40 mg of Triamcinolone
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
4 mg of Dexamethasone
Primary Outcome Measure Information:
Title
The Proportion of Subjects Reporting at Least 50% Overall Pain Relief
Description
The number of subjects reporting a minimum of 50% pain relief after receiving the injection.
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoun Nader, MD
Organizational Affiliation
Northwestern University Feinberg School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anesthesiology Pain Medcine Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Ultrasound Guided Trigeminal Nerve Block for Typical or Atypical Facial Pain
We'll reach out to this number within 24 hrs