Opioid Management Strategies for Postoperative Pain
Trial Summary
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.
What data supports the effectiveness of the treatment iPill Dispenser, Twin block for managing postoperative pain?
The research suggests that regional nerve blocks, which are part of multimodal pain management strategies, can effectively reduce pain and opioid use after surgery. This indicates that similar treatments, like the iPill Dispenser and Twin block, may also help manage postoperative pain by potentially reducing the need for opioids.12345
Is the opioid management strategy for postoperative pain generally safe for humans?
How does the Twin block treatment differ from other treatments for postoperative pain management?
The Twin block treatment is unique because it likely involves a combination of regional anesthesia techniques, such as transversus abdominis plane (TAP) blocks, which are known to reduce the need for opioids by providing targeted pain relief. This approach is part of a multimodal strategy that aims to manage pain effectively while minimizing opioid use, which is crucial in addressing the opioid crisis.111121314
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
Exclusion Criteria
Timeline
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
Treatment Details
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