Typical Facial PainPhase 4NCT02024724

Ultrasound Guided Trigeminal Nerve Block for Typical or Atypical Facial Pain

A Phase 4 study testing Bupivacaine, Triamcinolone and Dexamethasone in people with Typical Facial Pain and Atypical Facial Pain, run by Northwestern University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Typical Facial Pain, Atypical Facial Pain
What is being tested?: Bupivacaine, Triamcinolone and Dexamethasone
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteUnited States
Study dates: Nov 2013to Mar 2017
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Exclusion is the same for patients who are not eligible for ultrasound guided nerve blocks.

Trial locations and contacts

1 site in 1 country.

United States1 site

Anesthesiology Pain Medcine Center
Chicago, Illinois, 60611

Other trials in United States

About this study

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

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
Being tested: Bupivacaine, Triamcinolone, Dexamethasone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BupivacaineDrug
4 mL of 0.25% bupivacaine
TriamcinoloneDrug
40 mg of Triamcinolone
DexamethasoneDrug
4 mg of Dexamethasone

Study groups in NCT02024724
Study group	Role	What they receive
Dexamethasone	Active comparator	4 mg of Dexamethasone and 4 mL of 0.25% bupivacaine Receives: Drug: Bupivacaine; Drug: Dexamethasone
Triamcinolone	Active comparator	40 mg of Triamcinolone and 4 mL of 0.25% bupivacaine Receives: Drug: Bupivacaine; Drug: Triamcinolone

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2013Mar 2017

First posted31 Dec 2013 (estimated)
Study startNov 2013
Primary completionMar 2016
Study completionMar 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Typical Facial PainStudies of the same condition, open and under way.
More trials run by Northwestern UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02024724
Sponsor's protocol ID: STU00083918
Other IDs: STU00083918
Status last verified: Jun 2017
First submitted: 27 Dec 2013
Last updated: 11 Jul 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 4 Study Comparing of Dexamethasone to Triamcinolone for Ultrasound-guided Trigeminal Nerve Block: A Randomized Controlled Trial.
ClinicalTrials.gov ID: NCT02024724
Acronym / sponsor ID: STU00083918
Conditions: Typical Facial Pain, Atypical Facial Pain
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Northwestern UniversityUniversity, hospital or other
Study start: Nov 2013
Primary completion: Mar 2016 (actual)
Study completion: Mar 2017 (actual)
First posted: 31 Dec 2013 (estimated)
Results: Posted 7 Jun 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Dexamethasone	Active comparator	Drug: Bupivacaine, Drug: Dexamethasone4 mg of Dexamethasone and 4 mL of 0.25% bupivacaine
Triamcinolone	Active comparator	Drug: Bupivacaine, Drug: Triamcinolone40 mg of Triamcinolone and 4 mL of 0.25% bupivacaine

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

Exclusion is the same for patients who are not eligible for ultrasound guided nerve blocks.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Bupivacaine4 mL of 0.25% bupivacaine	Drug	Dexamethasone, Triamcinolone
Triamcinolone40 mg of Triamcinolone	Drug	Triamcinolone
Dexamethasone4 mg of Dexamethasone	Drug	Dexamethasone

Primary outcome

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

Results and safety

Results posted to the registry on 7 Jun 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 2	30	29
Group 1	30	30

Primary outcome: The Proportion of Subjects Reporting at Least 50% Overall Pain Relief

Time frame: 2 weeks. Count of participants. Unit: Participants

Measure	Group 1 n = 29	Group 2 n = 30
Greater than 50% Pain Relief Reported	19	14
Less than 50% Pain Relief Reported	10	16

Group 1 vs Group 2: Median Difference (Final Values): -30 (95% CI -45.00 to 10.00), p = .196, Chi-squared

Population analysed: Subjects reported percent relief at 2 weeks from receiving the ultrasound guided injection.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1	0 of 29 (0%)	0 of 29 (0%)	0 of 29
Group 2	0 of 30 (0%)	1 of 30 (3.3%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Antoun Nader, MD principal investigator

Northwestern University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Bupivacaine, Triamcinolone and Dexamethasone in people with Typical Facial Pain and Atypical Facial Pain, run by Northwestern University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Proportion of Subjects Reporting at Least 50% Overall Pain Relief (time frame: 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02024724.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2017.