Ultrasound Guided Trigeminal Nerve Block for Typical or Atypical Facial Pain

Atypical Facial Pain Clinical Trial

Official title:

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Atypical Facial Pain
• Facial Pain
• Facies
• Typical Facial Pain

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