Opioid Management Strategies for Postoperative Pain

Overseen By Gayathri Subramanian, PhD, DMD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Rutgers, The State University of New Jersey

Must not be taking: Opioids, NSAIDs

Disqualifiers: Acute infection, Cognitive disability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 week

133 Participants Needed

What You Need to Know Before You Apply

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.

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 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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{6 11 12 13 14}

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

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Preoperative transversus abdominis plane block decreases intraoperative opiate use during pancreatoduodenectomy. [2022]

2. England pubmed.ncbi.nlm.nih.gov

The association of multimodal analgesia and high-risk opioid discharge prescriptions in opioid-naive surgical patients. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Development and Implementation of a Neonatal Pain Management Guideline for Minor Surgeries. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Persistent Postoperative Opioid Prescription Fulfillment and Peripheral Nerve Blocks for Ambulatory Shoulder Surgery: A Retrospective Cohort Study. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

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]

6. United States pubmed.ncbi.nlm.nih.gov

The Burden of Opioid-Related Adverse Drug Events on Hospitalized Previously Opioid-Free Surgical Patients. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Opioid versus opioid-free analgesia after surgical discharge: protocol for a systematic review and meta-analysis. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Adverse drug events among patients receiving postsurgical opioids in a large health system: risk factors and outcomes. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

In the Arms of Morpheus without Morphia; Mitigating the United States Opioid Epidemic by Decreasing the Surgical Use of Opioids. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Postoperative recovery after breast cancer surgery: A randomised controlled trial of opioid-based versus opioid-free anaesthesia with thoracic paravertebral block. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

The Role of Exparel Plus Meloxicam for Postoperative Pain Management. [2020]

12. United States pubmed.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 States pubmed.ncbi.nlm.nih.gov

The Effects of Perioperative Peripheral Nerve Blocks on Peri- and Postoperative Opioid Use and Pain Management. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

A Review of Opioid-Sparing Modalities in Perioperative Pain Management: Methods to Decrease Opioid Use Postoperatively. [2022]