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Ultrasound Guided Trigeminal Nerve Block for Typical or Atypical Facial Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Antoun Nader, Northwestern University
ClinicalTrials.gov Identifier:
NCT02024724
First received: December 27, 2013
Last updated: June 14, 2017
Last verified: June 2017
  Purpose

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 Intervention Phase
Typical Facial Pain Atypical Facial Pain Drug: Bupivacaine Drug: Triamcinolone Drug: Dexamethasone Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Antoun Nader, Northwestern University:

Primary Outcome Measures:
  • 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.


Enrollment: 60
Study Start Date: November 2013
Study Completion Date: March 2017
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02024724

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

Responsible Party: Antoun Nader, Professor of Anesthesiology, Northwestern University
ClinicalTrials.gov Identifier: NCT02024724     History of Changes
Other Study ID Numbers: STU00083918
STU00083918 ( Other Identifier: Institutional Review Board (IRB) )
Study First Received: December 27, 2013
Results First Received: May 11, 2017
Last Updated: June 14, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Facies
Facial Pain
Disease Attributes
Pathologic Processes
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Dexamethasone acetate
Triamcinolone hexacetonide
Dexamethasone
Triamcinolone
Triamcinolone Acetonide
BB 1101
Triamcinolone diacetate
Bupivacaine
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 16, 2017