Ultrasound Guided Trigeminal Nerve Block for Typical or Atypical Facial Pain

NCT ID: NCT02024724

Last Updated: 2017-07-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2017-03-31

Brief Summary

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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

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Conditions

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Typical Facial Pain Atypical Facial Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Dexamethasone

4 mg of Dexamethasone and 4 mL of 0.25% bupivacaine

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

4 mL of 0.25% bupivacaine

Dexamethasone

Intervention Type DRUG

4 mg of Dexamethasone

Triamcinolone

40 mg of Triamcinolone and 4 mL of 0.25% bupivacaine

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

4 mL of 0.25% bupivacaine

Triamcinolone

Intervention Type DRUG

40 mg of Triamcinolone

Interventions

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Bupivacaine

4 mL of 0.25% bupivacaine

Intervention Type DRUG

Triamcinolone

40 mg of Triamcinolone

Intervention Type DRUG

Dexamethasone

4 mg of Dexamethasone

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Antoun Nader

Professor of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Antoun Nader, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University Feinberg School of Medicine

Locations

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Anesthesiology Pain Medcine Center

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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STU00083918

Identifier Type: OTHER

Identifier Source: secondary_id

STU00083918

Identifier Type: -

Identifier Source: org_study_id

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