Twin Block Anesthesia for Acute Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method to manage pain after wisdom tooth removal without opioids. Researchers are testing the "Twin Block" injection, which numbs the jaw muscles that often cause pain after the procedure. Participants will receive either this anesthetic or a placebo to determine its effectiveness in reducing pain and the need for opioids. The trial seeks healthy individuals experiencing significant jaw pain after the removal of at least one impacted wisdom tooth. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to innovative pain management solutions.
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 prior data suggests that the Twin Block dental anesthetic injection is safe for managing acute pain?
Research shows that local anesthetic nerve blocks, such as the Twin Block, are generally safe and well-tolerated. Previous studies have reported few complications with these anesthetics. Although there is a small risk of nerve damage, it remains rare. The Twin Block uses a common dental anesthetic, known to be safe for most people, and most individuals do not experience serious side effects. This makes the Twin Block a promising option for managing pain after wisdom teeth removal, potentially reducing the need for opioids without significant risk.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about the Twin Block Anesthesia because it could offer a new way to manage acute pain following dental procedures, like wisdom tooth extractions. Most standard treatments rely on oral pain medications, which can take time to work and may have systemic side effects. Unlike these options, the Twin Block approach directly targets the nerve using a local anesthetic, 2% lidocaine with 1:100,000 epinephrine, providing potentially faster and more localized pain relief. This method could mean quicker pain management with fewer side effects, making recovery from dental surgery more comfortable.
What evidence suggests that the Twin Block dental anesthetic injection is effective for reducing pain after wisdom tooth removal?
Research has shown that the Twin Block injection effectively reduces pain in the jaw muscles. In earlier studies, this method provided quick and long-lasting relief for pain in the jaw and nearby muscles. Some reports indicate it also alleviates pain, swelling, and muscle stiffness after wisdom tooth removal. In this trial, participants will be randomized to receive either the Twin Block with a local anesthetic or the Twin Block with sterile normal saline. The Twin Block numbs the nerves controlling the jaw muscles, reducing pain in these areas. This suggests that using the Twin Block could decrease the need for opioids after dental surgery, offering relief without the risk of addiction.14678
Who Is on the Research Team?
Gayathri Subramanian, PhD, DMD
Principal Investigator
Rutgers School of Dental Medicine, Newark NJ
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
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