Ultrasound Guided Trigeminal Nerve Block for Typical or Atypical Facial Pain

NCT02024724 | Completed Phase 4 Results

• 1 other identifier: STU00083918
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Typical Facial Pain; Atypical Facial Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  2 weeks

Study Arms (2)

Dexamethasone

ACTIVE COMPARATOR

4 mg of Dexamethasone and 4 mL of 0.25% bupivacaine

Drug: Bupivacaine; Drug: Dexamethasone

Triamcinolone

ACTIVE COMPARATOR

40 mg of Triamcinolone and 4 mL of 0.25% bupivacaine

Drug: Bupivacaine; Drug: Triamcinolone

Interventions

Bupivacaine DRUG

4 mL of 0.25% bupivacaine

Dexamethasone; Triamcinolone

Triamcinolone DRUG

40 mg of Triamcinolone

Triamcinolone

Dexamethasone DRUG

4 mg of Dexamethasone

Dexamethasone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients presenting to the Northwestern Pain Center who are eligible and scheduled to receive a ultrasound-guided trigeminal nerve block.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Anesthesiology Pain Medcine Center

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Interventions

Bupivacaine; Triamcinolone; Dexamethasone

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Pregnadienetriols

Results Point of Contact

• Title: Antoun Nader, M.D.
• Organization: Northwestern University, Feinberg School of Medicine

a-nader2@northwestern.edu

312-695-4814

Study Officials

• Antoun Nader, MD

  Northwestern University Feinberg School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Study Record Dates

• First Submitted: December 27, 2013
• First Posted: December 31, 2013
• Study Start: November 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2017
• Last Updated: July 11, 2017
• Results First Posted: June 7, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)