Ultrasound Guided Trigeminal Nerve Block for Typical or Atypical Facial Pain

Phase 4

Completed

• Conditions: Atypical Facial Pain; Typical Facial Pain
• Interventions: Drug: Bupivacaine; Drug: Dexamethasone; Drug: Triamcinolone

• Registration Number: NCT02024724
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-12-27
• Study First Submitted QC: 2013-12-27
• Study First Posted: 2013-12-31
• Primary Completion: 2016-03
• Study Completion: 2017-03
• Results First Submitted: 2017-05-11
• Results First Submitted QC: 2017-05-11
• Status Verified: 2017-06
• Results First Posted: 2017-06-07
• Last Update Submitted: 2017-06-14
• Last Update Posted: 2017-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexamethasone	Dexamethasone	4 mg of Dexamethasone and 4 mL of 0.25% bupivacaine
Dexamethasone	Bupivacaine	4 mg of Dexamethasone and 4 mL of 0.25% bupivacaine
Triamcinolone	Bupivacaine	40 mg of Triamcinolone and 4 mL of 0.25% bupivacaine
Triamcinolone	Triamcinolone	40 mg of Triamcinolone and 4 mL of 0.25% bupivacaine

Primary Outcome Measures

Name	Time	Method
The Proportion of Subjects Reporting at Least 50% Overall Pain Relief	2 weeks	The number of subjects reporting a minimum of 50% pain relief after receiving the injection.

Trial Locations

Locations (1)

Anesthesiology Pain Medcine Center; 🇺🇸 Chicago, Illinois, United States