133 Participants Needed

Opioid Management Strategies for Postoperative Pain

AA
GS
Overseen ByGayathri Subramanian, PhD, DMD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Rutgers, The State University of New Jersey
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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?

Research shows that using opioids for postoperative pain can lead to adverse drug events (unwanted side effects) and may increase the risk of continued opioid use after surgery. It's important to consider alternative pain management strategies to minimize these risks.678910

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

AA

Anayo Adachie, DMD, MD

Principal Investigator

Rutgers School of Dental Medicine

GS

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.
See 7 more

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.
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

1 week
1 visit (in-person)

Monitoring

Opioid consumption and pain levels are tracked using the iPill Dispenser and IEM for 96 hours post-procedure

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse events and dispenser performance

4 weeks

Treatment Details

Interventions

  • iPill Dispenser
  • Twin 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
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Twin Block local anestheticExperimental Treatment2 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: ControlPlacebo Group1 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

Find a Clinic Near You

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+

Findings from Research

A study of 32,511 opioid-naïve surgical patients showed that the use of multimodal analgesia increased significantly from 2012 to 2018, leading to a decrease in high-risk opioid prescriptions at discharge from 34.1% to 17.7%.
Despite improvements in pain management, about 20% of patients still received high-risk opioid prescriptions, indicating that careful consideration of pre-discharge opioid use and multimodal analgesia is essential for safe prescribing practices.
The association of multimodal analgesia and high-risk opioid discharge prescriptions in opioid-naive surgical patients.Langnas, E., Rodriguez-Monguio, R., Luo, Y., et al.[2023]
In a study of 13,389 opioid-free patients who underwent surgery, 9.1% experienced opioid-related adverse drug events (ORADEs) after receiving postoperative opioids, highlighting a significant risk in this population.
Patients with ORADEs faced severe consequences, including 32% higher hospitalization costs, 45% longer hospital stays, and 2.2 times the odds of mortality, emphasizing the need for careful management of opioid use post-surgery.
The Burden of Opioid-Related Adverse Drug Events on Hospitalized Previously Opioid-Free Surgical Patients.Urman, RD., Seger, DL., Fiskio, JM., et al.[2023]
In a study of 6,285 patients undergoing surgery, 11.5% experienced opioid-related adverse drug events (ORADEs), highlighting a significant risk associated with postsurgical opioid use.
Patients with multiple risk factors for ORADEs, such as older age and prior opioid use, faced much higher hospitalization costs and longer stays, indicating the need for careful management of opioid prescriptions in at-risk populations.
Adverse drug events among patients receiving postsurgical opioids in a large health system: risk factors and outcomes.Minkowitz, HS., Gruschkus, SK., Shah, M., et al.[2022]

References

Preoperative transversus abdominis plane block decreases intraoperative opiate use during pancreatoduodenectomy. [2022]
The association of multimodal analgesia and high-risk opioid discharge prescriptions in opioid-naive surgical patients. [2023]
Development and Implementation of a Neonatal Pain Management Guideline for Minor Surgeries. [2023]
Persistent Postoperative Opioid Prescription Fulfillment and Peripheral Nerve Blocks for Ambulatory Shoulder Surgery: A Retrospective Cohort Study. [2021]
Comparison of Regional Anesthesia Timing on Pain, Opioid Use, and Postanesthesia Care Unit Length of Stay in Patients Undergoing Open Reduction and Internal Fixation of Ankle Fractures. [2021]
The Burden of Opioid-Related Adverse Drug Events on Hospitalized Previously Opioid-Free Surgical Patients. [2023]
Opioid versus opioid-free analgesia after surgical discharge: protocol for a systematic review and meta-analysis. [2023]
Adverse drug events among patients receiving postsurgical opioids in a large health system: risk factors and outcomes. [2022]
In the Arms of Morpheus without Morphia; Mitigating the United States Opioid Epidemic by Decreasing the Surgical Use of Opioids. [2021]
Postoperative recovery after breast cancer surgery: A randomised controlled trial of opioid-based versus opioid-free anaesthesia with thoracic paravertebral block. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
The Role of Exparel Plus Meloxicam for Postoperative Pain Management. [2020]
12.United Statespubmed.ncbi.nlm.nih.gov
Comparison of Liposomal Bupivacaine to a Local Analgesic Cocktail for Transversus Abdominis Plane Blocks in Abdominally Based Microvascular Breast Reconstruction. [2022]
13.United Statespubmed.ncbi.nlm.nih.gov
The Effects of Perioperative Peripheral Nerve Blocks on Peri- and Postoperative Opioid Use and Pain Management. [2022]
14.United Statespubmed.ncbi.nlm.nih.gov
A Review of Opioid-Sparing Modalities in Perioperative Pain Management: Methods to Decrease Opioid Use Postoperatively. [2022]
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