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Ultrasound Guided Trigeminal Nerve Block for Typical or Atypical Facial Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02024724
Recruitment Status : Completed
First Posted : December 31, 2013
Results First Posted : June 7, 2017
Last Update Posted : July 11, 2017
Information provided by (Responsible Party):
Antoun Nader, Northwestern University

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.

Condition or disease Intervention/treatment Phase
Typical Facial Pain Atypical Facial Pain Drug: Bupivacaine Drug: Triamcinolone Drug: Dexamethasone Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 4 Study Comparing of Dexamethasone to Triamcinolone for Ultrasound-guided Trigeminal Nerve Block: A Randomized Controlled Trial.
Study Start Date : November 2013
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2017

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

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02024724

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United States, Illinois
Anesthesiology Pain Medcine Center
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
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Principal Investigator: Antoun Nader, MD Northwestern University Feinberg School of Medicine

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Responsible Party: Antoun Nader, Professor of Anesthesiology, Northwestern University Identifier: NCT02024724     History of Changes
Other Study ID Numbers: STU00083918
STU00083918 ( Other Identifier: Institutional Review Board (IRB) )
First Posted: December 31, 2013    Key Record Dates
Results First Posted: June 7, 2017
Last Update Posted: July 11, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Facial Pain
Disease Attributes
Pathologic Processes
Neurologic Manifestations
Signs and Symptoms
Dexamethasone acetate
Triamcinolone Acetonide
Triamcinolone hexacetonide
BB 1101
Triamcinolone diacetate
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local