Opioid Management Strategies for Postoperative Pain

Overseen By Gayathri Subramanian, PhD, DMD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Rutgers, The State University of New Jersey

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

Reducing opioid prescription related use and misuse is a major focus for countering the national epidemic of opioid overdose and death. Annually, over 3.5 million predominantly young and healthy individuals undergo outpatient third molar ('wisdom tooth') tooth extractions under sedation and routinely receive postoperative opioid prescriptions. This procedure is among the most prevalent instances of opioid prescriptions dispensed to adolescents, a vulnerable population. This overuse can be minimized by bringing about immediate and sustained pain relief following extractions and by proper monitoring to regulate post-operative opioid usage. The investigators developed the Twin block, a local anesthetic nerve block that rapidly eases pain from the 'closer' muscles of the jaw and showed its long-term effectiveness in patients with chronic jaw muscle pain. Administering the Twin block immediately following third molar extractions will be an innovative and effective modality to alleviate acute post-procedure pain experienced by the patient and hence reduce the need for post-operative opioid pain medication. In order to tightly regulate when, how many and to whom the prescribed opioid pill is accessible, this study will utilize the iPill Dispenser®, an active pill dispenser. The iPill device, designated as a Class I 510(k) exempt device by the FDA, includes an App that utilizes biometric user authentication to operate a portable tamper-resistant, pre-calibrated device to regulate, deliver, and monitor opioid usage for pain, preventing overconsumption and diversion. The investigators further plan to 'track' pill swallowing by encapsulating the medication with an ingestible event marker (IEMs, FDA approved Class II device). The hypothesis of this study is that reduction in opioid prescription and its unwarranted use following third molar extractions can be achieved by a combination of Twin block, an active pill dispenser and ingestion tracking. The Specific Aims are: Specific Aim 1. Compare highest pain after third molar tooth extractions, in patients with and without the twin block. Specific Aim 2. Compare postoperative opioid consumption during the first 4 days following third molar tooth extractions between patients who got the twin block, with those who do not. Using the iPill dispenser and app and the IEM, the investigators will track opioid consumption for severe pain.

Research Team

Anayo Adachie, DMD, MD

Principal Investigator

Rutgers School of Dental Medicine

Gayathri Subramanian, PhD DMD

Principal Investigator

Rutgers School of Dental Medicine

Eligibility Criteria

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

I am getting at least one lower wisdom tooth removed under sedation.

You are classified as being in good health by the American Society of Anesthesiologists.

I have never had symptoms of jaw joint (TMD) problems.

Exclusion Criteria

You have been prescribed opioid medication for pain in the past.

I regularly use medication like NSAIDs or muscle relaxants for pain or inflammation.

I am allergic to certain local anesthetics, epinephrine, or opioids.

Treatment Details

Interventions

• iPill Dispenser (Other)
• Twin block (Local Anesthetic Nerve Block)

Trial Overview The study tests if using Twin block anesthesia can reduce pain after wisdom tooth removal and decrease opioid use when paired with an iPill dispenser that controls pill access. Pain levels and opioid consumption will be compared between patients with and without Twin block.

Participant Groups

Group I: Twin Block local anesthetic Experimental Treatment 2 Interventions

Patients undergoing extractions of lower wisdom molar/s under intravenous sedation will receive the Twin block local anesthetic (using the standard dental anesthetic 1.8 cc 2% lidocaine with 1:100,000 epinephrine), once, on the side/s of their extraction/s

Group II: Control Placebo Group 1 Intervention

Patients undergoing extractions of lower wisdom molar/s under intravenous sedation will receive the Twin block injection but with no medication administered/dispensed from the syringe, on the side/s of their extraction/s

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

iPill Dispenser

Collaborator

Trials

1

Recruited

130+