Opioid-Dispensing Device for Postoperative Pain

Overseen By Alexandra Sideris, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Hospital for Special Surgery, New York

Disqualifiers: Opioid-tolerance, No smartphone, Pregnancy, others

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

Compensation: Varies

Number of Visits: 1

Duration: 2 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new opioid-dispensing device can help patients safely manage pain after spine surgery. The device releases medication only at specific times through a mobile app, potentially reducing misuse and promoting proper use. Participants will use either this new device or a standard pill bottle, and researchers will monitor their opioid use and pain levels for two weeks post-surgery. Those who have had spine surgery and do not regularly use opioids may be suitable candidates. The goal is to assess whether this device better assists patients in managing pain responsibly compared to regular pill bottles. As an unphased trial, this study offers patients an opportunity to contribute to innovative pain management solutions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that participants should be opioid-naive or intermittent opioid users, which suggests that regular opioid users may need to stop or adjust their usage before participating.

What prior data suggests that this opioid-dispensing device is safe for postoperative pain management?

Research has shown that opioids can relieve pain after surgery, but they may also cause side effects. Common issues include constipation, nausea, and vomiting. More serious side effects can include extreme drowsiness and breathing difficulties, which can be dangerous. Long-term opioid use can also lead to addiction.

The new device in this study aims to make opioid use safer by controlling when pills can be taken. This approach seeks to prevent misuse and improve pain management. Although specific studies on this device have not yet been conducted, the goal is to reduce the risks associated with opioids. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Opioid-Dispensing Device for postoperative pain because it offers a new way to manage pain with greater control and safety. Unlike traditional opioid pill bottles, this device is paired with an app that helps track usage and ensures the patient receives the correct dose at the right time. This approach aims to reduce the risk of overuse and addiction, which are significant concerns with standard opioid treatments. By improving monitoring and dosing precision, the device could lead to safer pain management after surgery.

What evidence suggests that this opioid-dispensing device is effective for postoperative pain management?

Research has shown that using opioids after surgery can sometimes lead to long-term addiction. One study found that 9.1% of patients who had never used opioids before experienced negative effects after surgery. This highlights the need for safer opioid management strategies. In this trial, participants will join one of two groups: one using a standard opioid pill bottle with an app, and the other using an opioid-dispensing device with an app. The opioid-dispensing device controls when patients can take their medication, potentially reducing misuse and enhancing patient safety. ^{1 2 6 7 8}

Who Is on the Research Team?

Vladimir Kramskiy, MD

Principal Investigator

Hospital for Special Surgery, New York

Are You a Good Fit for This Trial?

This trial is for patients who have undergone spine surgery (microdiscectomy or laminectomy) and require pain management. Participants should be willing to use an app to track their pain and opioid usage post-surgery. Those with a history of opioid misuse or conditions that might interfere with the study are likely excluded.

Inclusion Criteria

I haven't regularly used opioids in the last 3 months.

I will be discharged the same day as my surgery or within 23 hours.

I am scheduled for a specific spine surgery (lumbar laminectomy or discectomy) with a participating surgeon.

Exclusion Criteria

I prefer or need to use a painkiller that is not oxycodone.

I have chosen not to participate in certain treatments or procedures.

I will be staying in the hospital after my surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a standard pill bottle with opioids or an opioid-dispensing device, and track their opioid use and pain scores for two weeks after surgery

2 weeks

Daily tracking via app

Follow-up

Participants are monitored for opioid use, pain scores, and satisfaction with the device or app, with a telehealth session to count remaining pills

2 weeks

1 telehealth session

Extended Follow-up

Opioid prescription refill rates are monitored using electronic health records

6 weeks postoperatively

What Are the Treatments Tested in This Trial?

Interventions

• Opioid-Dispensing Device

Trial Overview The study tests an innovative opioid-dispensing device against standard pill bottles in managing postoperative pain. Half the participants will receive opioids via a new dispenser that works with an app providing timed access, while the other half will use traditional bottles and manually log intake.

How Is the Trial Designed?

Group I: Opioid-Dispensing Device with App Experimental Treatment 2 Interventions

Group II: Standard Opioid Pill Bottle with App Active Control 2 Interventions

Who Is Running the Clinical Trial?

Hospital for Special Surgery, New York

Lead Sponsor

Trials

257

Recruited

61,800+

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 systematic review of 34 trials involving 5,546 patients found that oral opioids used for non-cancer pain resulted in higher rates of adverse events compared to placebo, with common issues including dry mouth (25%), nausea (21%), and constipation (15%).

Approximately 22% of patients discontinued opioid treatment due to adverse events, highlighting the potential safety concerns associated with opioid use in non-cancer pain management, especially since most trials lasted less than four weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of opioid adverse events in chronic non-malignant pain: systematic review of randomised trials of oral opioids. Moore, RA., McQuay, HJ.[2022]

Acute postoperative pain is often not managed effectively worldwide, highlighting a significant gap in patient care that can impact recovery and overall health.

The article discusses new analgesics and advanced delivery methods that could enhance pain management strategies for patients experiencing moderate-to-severe postoperative pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative pain management: new, convenient analgesic therapies. Power, I., McCormack, J.[2019]

Opioid-related adverse drug events (ADEs) significantly increase hospital costs by 7.4% and length of stay (LOS) by 10.3% in surgical patients, indicating a substantial financial impact on healthcare systems.

Patients receiving higher doses of opioids are at a greater risk of experiencing ADEs, suggesting that careful management of opioid dosages is crucial to minimize complications and associated costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opioid-related adverse drug events in surgical hospitalizations: impact on costs and length of stay. Oderda, GM., Said, Q., Evans, RS., et al.[2022]

Opioid medications, particularly those targeting the μ-opioid receptor (μOR), are the most effective for pain management but come with serious side effects like respiratory depression and dependence.

There is a critical need for the development of new μOR analgesics that maintain pain relief properties while minimizing or eliminating adverse effects, as highlighted by recent research advancements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Designing Safer Analgesics via μ-Opioid Receptor Pathways. Chan, HCS., McCarthy, D., Li, J., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7440649/

Postsurgical Opioid Prescriptions and Risk of Long-term Use Overall, 55.5% received an opioid for postoperative pain, with median days supply =5 and median total MME = 240. The proportion of patients receiving ...

2. withpower.com withpower.com/trial/phase-pain-postoperative-4-2024-804e4

Opioid-Dispensing Device for Postoperative Pain In a study of 13,389 opioid-free patients who underwent surgery, 9.1% experienced opioid-related adverse drug events (ORADEs) after receiving postoperative ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2820373

Epidemiology of Opioid Prescribing After Discharge From ... In the context of surgical care, numerous studies have demonstrated an association between opioid prescribing for postoperative pain and opioid- ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11290948/

Predicting Postoperative Pain and Opioid Use with Machine ... The present study explored the potential for ML models to predict postoperative acute pain and chronic opioid use. Our modeling strategy integrated preoperative ...

5. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(19)30732-5/fulltext

Postoperative opioid prescription patterns and new ... Postoperative opioid prescription rate after CIED procedures was 20.2%, with most patients being opioid naïve. Among opioid naïve patients who ...

6. cdc.gov cdc.gov/mmwr/volumes/71/rr/rr7103a1.htm

CDC Clinical Practice Guideline for Prescribing Opioids ... This guideline provides recommendations for clinicians providing pain care, including those prescribing opioids, for outpatients aged ≥18 years.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S002248042300450X

Adherence to Opioid Prescribing Guidelines in a Statewide ... Postoperative patients who receive an opioid prescription have a 3%-7% risk of developing a chronic opioid abuse problem,1,14, 15, 16 and up to 70% of chronic ...

8. journals.lww.com journals.lww.com/aosopen/fulltext/2024/12000/postoperative_opioid_consumption_after_discharge_.18.aspx

Postoperative Opioid Consumption After Discharge Opioids remain a common treatment for postoperative pain of moderate-to-severe intensity not adequately addressed by nonopioid analgesics, but excessive ...