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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02024724
Other study ID # STU00083918
Secondary ID STU00083918
Status Completed
Phase Phase 4
First received December 27, 2013
Last updated December 9, 2016
Start date November 2013

Study information

Verified date December 2016
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Drug:
Bupivacaine
4 mL of 0.25% bupivacaine
Triamcinolone
40 mg of Triamcinolone
Dexamethasone
4 mg of Dexamethasone

Locations

Country Name City State
United States Anesthesiology Pain Medcine Center Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The proportion of subjects reporting at least 50% overall pain relief 2 weeks No
Secondary block satisfaction 2 weeks No
See also
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