Opioid Management Strategies for Postoperative Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial seeks better ways to manage pain after wisdom teeth removal while reducing opioid reliance. The focus is on a new pain relief method called the Twin block, a type of local anesthetic, to alleviate jaw pain after tooth extractions. Additionally, the trial uses an iPill Dispenser® to control and track opioid use, ensuring patients only use what they need. Individuals having wisdom teeth removed, with no history of jaw disorders or surgeries, and who own a smartphone are suitable candidates for this trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to benefit from innovative pain management methods.
Will I have to stop taking my current medications?
The trial requires that participants do not have a history of chronic use of certain medications like NSAIDs (non-steroidal anti-inflammatory drugs) or muscle relaxants. If you are using these regularly, you may need to stop before participating.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the Twin block, which uses lidocaine as a local numbing medicine, is generally safe. Studies have found that 2% lidocaine with epinephrine (a medicine that narrows blood vessels) works effectively and is usually well-tolerated. For instance, one study found this combination safe for dental procedures like wisdom tooth removal.
Most people do not experience serious side effects from lidocaine. Some might feel temporary numbness or a slight tingling sensation, which are normal and usually not a concern. In rare cases, an allergic reaction may occur, but this is uncommon.
Overall, the Twin block appears to be a safe method for managing pain after dental surgery. It may help reduce the need for opioid painkillers, which can have more serious side effects and potential for misuse.12345Why are researchers excited about this trial?
Researchers are excited about the Twin block local anesthetic because it offers a targeted approach to managing postoperative pain after wisdom tooth extractions. Unlike standard treatments, which often rely on systemic opioids that affect the whole body, the Twin block method delivers local anesthesia directly to the surgical site. This approach uses a standard dental anesthetic, 2% lidocaine with epinephrine, to effectively numb the area, potentially reducing the need for opioids and minimizing their associated side effects. By focusing on local pain management, the Twin block may offer quicker recovery times and a safer, more comfortable experience for patients.
What evidence suggests that the Twin block and iPill Dispenser could be effective for managing postoperative pain and reducing opioid use?
Research has shown that the Twin block, a type of local anesthetic, effectively reduces pain after dental surgeries like wisdom tooth extractions. In this trial, participants will receive either the Twin block local anesthetic or a control treatment. One study found that using lidocaine with epinephrine, components of the Twin block, significantly lowered pain levels just hours after surgery compared to other methods. Another study found that patients who received the Twin block needed less pain medication afterward, with 86.7% not requiring extra pain pills. These findings suggest that the Twin block provides quick and lasting pain relief, potentially reducing the need for opioids after surgery.56789
Who Is on the Research Team?
Anayo Adachie, DMD, MD
Principal Investigator
Rutgers School of Dental Medicine
Gayathri Subramanian, PhD DMD
Principal Investigator
Rutgers School of Dental Medicine
Are You a Good Fit for This Trial?
Adults over 18 without a history of jaw disorders, trauma, or surgery in the maxillofacial area who are getting at least one 'wisdom' tooth removed. Participants must be healthy (ASA I), able to consent, not part of a vulnerable population, and have a compatible smartphone for the iPill App.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 extractions and receive either the Twin block or a sham injection, with opioid usage monitored using the iPill Dispenser and IEM
Monitoring
Opioid consumption and pain levels are tracked using the iPill Dispenser and IEM for 96 hours post-procedure
Follow-up
Participants are monitored for safety and effectiveness after treatment, including adverse events and dispenser performance
What Are the Treatments Tested in This Trial?
Interventions
- iPill Dispenser
- Twin block
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rutgers, The State University of New Jersey
Lead Sponsor
iPill Dispenser
Collaborator