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

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. ^{1 2 3 4 5}

Why 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. ^{5 6 7 8 9}

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

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]

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 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

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Effectiveness of Lidocaine with Epinephrine Irrigation in ...

Continuous local anesthetic irrigation appears to be effective in reducing acute postoperative pain in patients with IANB for MA-impacted third molar surgery.

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The twin-mix also significantly reduced pain under local anesthesia, shortened latency and prolonged duration of anesthesia. Conclusion. In conclusion, the use ...

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Effectiveness of Lidocaine with Epinephrine Irrigation in ...

Results: The VAS levels at 3 and 4 h after surgery in the lidocaine group were significantly lower than those of the normal saline group.

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cureus.com/articles/391123-comparative-evaluation-of-the-effectiveness-of-2-lignocaine-mixed-with-dexamethasone-4-mg-vs-2-lignocaine-1200000-epinephrine-for-pain-control-during-the-removal-of-orthodontically-indicated-mandibular-premolars-a-randomized-controlled-trial.pdf?email=

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Notably, the twin‑mix group also required less postoperative analgesia; 86.7% did not need further pain relief compared to 76.7% in the control ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7113948/

Comparative evaluation of efficacy and latency of twin mix ...

[4] This study compares the effectiveness of pterygomandibular nerve block using 2% lignocaine HCL with 1:80,000 adrenaline to twin mix (4 mg of ...

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pmc.ncbi.nlm.nih.gov

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Anesthetic efficacy and safety of 2% lidocaine hydrochloride ...

Therefore the present study was conducted to compare the efficacy and safety of 2% lidocaine HCl with 1:100,000 adrenaline and 4% articaine HCl with 1:100,000 ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT04787731

Efficacy of Two Local Anesthetics on Quality of Life After ...

Subjects' oral health related quality of life and postoperative pain resolution, pain medication use and numbness will be compared in two study groups. Detailed ...

8.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0099239907009934

Anesthetic Efficacy of 1.8 mL and 3.6 mL of 2% Lidocaine ...

The purpose of this prospective, randomized, single-blinded study was to measure the degree of anesthesia obtained with 1.8 mL and 3.6 mL of 2% lidocaine ...

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Comparison of the efficacy and safety of 2% lidocaine HCl...

Local anesthesia is employed for removing the third molar. This study aimed to evaluate the efficacy and safety of 2% lidocaine with 1:80,000 or 1:200,000 ...