Twin Block Anesthesia for Acute Pain
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have used opioid pain medications in the past or are on long-term anti-inflammatory pain medication.
What data supports the effectiveness of the Twin Block Anesthesia treatment for acute pain?
The Twin Block Injection has been shown to be effective in managing masticatory myofascial pain, which suggests it may help with other types of acute pain. Additionally, regional anesthesia, like nerve blocks used in dental procedures, is becoming a standard for pain management, indicating its potential effectiveness.12345
Is Twin Block Anesthesia generally safe for humans?
How is the Twin Block local anesthetic nerve block treatment different from other treatments for acute pain?
The Twin Block local anesthetic nerve block is unique because it targets specific branches of the trigeminal nerve, which may provide more effective pain relief for conditions like masticatory myofascial pain compared to other nerve blocks. It is a novel approach that has shown promise in managing pain associated with the temporomandibular joint (TMJ) and differs from standard dental anesthetic techniques by its specific nerve targeting.211121314
What is the purpose of this trial?
Each year, over 3.5 million, mostly, healthy young adults, have their third molar teeth ('wisdom teeth') removed under sedation and are often given opioid prescriptions for managing their pain. Wisdom molar removal is one of the most common reasons for opioid prescriptions to be given to adolescents. There is a national thrust to reduce both the dose and the duration of such opioid prescriptions because even short-term opioid exposures increase risk for narcotic addiction and misuse. Non-opioid options to manage pain will still allow for sufficient pain control without risking addiction, and hence, a fundamental component of our response to combat the current national opioid crisis.The investigators are going to study a promising option- the Twin Block dental anesthetic injection. The Twin block involves injecting the standard dental numbing medication in a way that 'numbs' the 'jaw-clencher' muscles on the side of the face. The investigators found that the Twin block relieved jaw pain stemming from these muscles, in a quick and sustained manner, even in patients whose pain following wisdom tooth removal primarily came from 'taut' and tender jaw-clencher muscles. However, what is not known is- how often do patients who have their wisdom teeth removed under sedation, end up in significant pain from taut and tender jaw-clencher muscles? Will using the twin block effectively reduce pain in such patients? In this pilot study, the investigators will examine wisdom molar extraction patients one day after their procedure. Those with significant pain (pain rated ≥ 5 on a 0-10 scale) in their jaw-clencher muscles, will get either the Twin block injection or a placebo. The investigators will track both 1) pain before and after the injection, and 2) pain medication usage over a 7-day period to see if both pain and opioid dosage come down with the Twin block. This study can support a simple, safe and inexpensive means to reduce pain after a common procedure.
Research Team
Gayathri Subramanian, PhD, DMD
Principal Investigator
Rutgers School of Dental Medicine, Newark NJ
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo third molar extraction under intravenous sedation and receive either the Twin block or placebo injection based on randomization
Follow-up
Participants are monitored for pain levels and opioid consumption over a 7-day period
Treatment Details
Interventions
- Twin Block local anesthetic nerve block using standard dental anesthetic
- Twin block with placebo
Twin Block local anesthetic nerve block using standard dental anesthetic is already approved in United States, European Union for the following indications:
- Pain management for third molar extractions
- Pain management for dental procedures
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rutgers, The State University of New Jersey
Lead Sponsor
New Jersey Health Foundation
Collaborator
New Jersey Health Foundation
Collaborator