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Twin Block Anesthesia for Acute Pain

Phase 2

Recruiting

Led By Gayathri Subramanian, PhD, DMD

Research Sponsored by Rutgers, The State University of New Jersey

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with no past/recent pain or reduced range of motion in their jaw joint/muscle complex, no trauma or surgery in their jaw region

Patients requiring extraction/s of at least 1 lower wisdom (third) molar that is partially/fully 'impacted', under intravenous sedation

Must not have

Patients with compromised ability to guard their self-interest, e.g., prisoners, children, pregnant women, patients with intellectual/cognitive disability

Patients allergic to/unable to tolerate either the dental local anesthetic or its components, opioids, acetaminophen ('Tylenol') or ibuprofen ('Motrin' or 'Advil')

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one week

Summary

This trial is testing whether using a twin block injection to numb the 'jaw-clencher' muscles can reduce pain and the need for opioids following wisdom tooth removal.

Who is the study for?

This trial is for healthy adults over 18 needing at least one lower wisdom tooth removed, who can use a smart device with internet. They shouldn't have jaw pain or limited motion history, be pregnant, prisoners, children, or intellectually disabled. Allergies to local anesthetics or common pain relievers like Tylenol and Advil are disqualifiers.

What is being tested?

The study tests the Twin Block dental anesthetic injection versus a placebo in managing post-wisdom tooth removal pain. It aims to see if this technique reduces both the intensity of jaw-clencher muscle pain and the need for opioid medication after surgery.

What are the potential side effects?

While not explicitly stated in the provided information, typical side effects from dental anesthesia may include temporary numbness or tingling sensations, minor bruising where injected, slight bleeding around injection sites and rarely allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have not had jaw pain, limited movement, trauma, or surgery recently.

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I need at least one lower wisdom tooth removed and it's partially or fully stuck.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not a prisoner, child, pregnant, or have an intellectual disability.

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I am allergic to or cannot tolerate dental anesthetics, opioids, Tylenol, or Advil.

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I have an infection in my wisdom teeth that will be removed on the day of my procedure.

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I have had long-term jaw joint or muscle pain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one week

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one week

This trial's timeline: 3 weeks for screening, Varies for treatment, and one week for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean NRS pain score

Post-injection muscle pain

Total prescription opioid consumption

Secondary study objectives

Passive mouth opening

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Twin Block with Local AnestheticActive Control1 Intervention

Following lower third molar extraction under intravenous sedation, the patient randomized to this arm with receive the Twin block local anesthetic nerve block using the standard dental local anesthetic, i.e,. 2% lidocaine with 1:100,000 epinephrine, on the day after extraction, if the patient has pain greater than or equal to 5 on 10 in their jaw-closer muscles (Numerical Pain rating scale).

Group II: Twin Block with sterile normal salinePlacebo Group1 Intervention

Following lower third molar extraction under intravenous sedation, the patient randomized to this arm with receive the Twin block using sterile normal saline, on the day after extraction, if the patient has pain greater than or equal to 5 on 10 in their jaw-closer muscles (Numerical Pain rating scale).

0 / 6Eligibility criteria met