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

Trial Summary

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 data supports the effectiveness of the Opioid-Dispensing Device treatment for postoperative pain?

The research suggests that techniques allowing patients to control their own pain medication, like Patient Controlled Analgesia, can improve pain management after surgery. This implies that an Opioid-Dispensing Device, which may offer similar control, could be effective in managing postoperative pain. ^{1 2 3 4 5}

Is the Opioid-Dispensing Device generally safe for humans?

Opioid medications, which may be used in devices like the Opioid-Dispensing Device, can cause side effects such as constipation, nausea, and sedation. They are also associated with more serious risks like respiratory depression (slowed breathing) and dependence. While efforts are being made to develop safer opioids, these side effects are common in both short-term and long-term use. ^{6 7 8 9 10}

How does the opioid-dispensing device for postoperative pain differ from other treatments?

The opioid-dispensing device for postoperative pain is unique because it offers a novel drug delivery method that could improve pain management by providing a more controlled and potentially safer way to administer opioids compared to traditional methods like intravenous or oral administration. ^{11 12 13 14 15}

What is the purpose of this trial?

The opioid crisis continues to plague the United States. While great strides have been made nationwide to decrease overprescribing, improvements are still needed to appropriately educate patients on the safe and responsible use, storage and disposal of opioids. Pain after surgery is often treated with opioid medications. Opioid medications can have side effects. Some side effects are relatively minor (constipation, nausea, vomiting), while others are more severe (sedation, abnormal breathing, etc.) and can lead to serious illness or death. Opioid pain medications when used the wrong way may also be addictive. Due to theses side effects, sometimes patients feel uncomfortable about taking these medications, and doctors prescribe them very cautiously. However, when used properly and safely, opioid pain medications are excellent pain relievers. Addinex, a technology company, has developed a device to help patients take opioids more safely. In this study the investigators aim to enroll a total of 30 patients who undergo spine surgery. Half will be randomly assigned to receive a standard pill bottle with opioids at discharge and will download a mobile app so that they can record their daily pain scores and the number of opioids they take for two weeks after surgery. The other half will receive the new opioid dispenser filled with opioids and a mobile app that generates a passcode that opens that device only at designated times. For this group of patients, every time the patient wants to take an opioid, they need to go to the app, enter their pain score before the app generates a passcode. The investigators will be tracking all study patients' opioid use and pain scores for the two weeks after surgery, will count how many pills they have left over 14 days after their surgery during a live telehealth session, and ask patients how they liked using the device. Results from this study will help understand if the Addinex device could potentially be useful to patients in the future after surgeries as opposed to typical pill bottles.

Research Team

Vladimir Kramskiy, MD

Principal Investigator

Hospital for Special Surgery, New York

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

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

An Interactive Pain Application (MServ) Improves Postoperative Pain Management. [2021]

2. France pubmed.ncbi.nlm.nih.gov

[Optimal use of the administration of morphine derivatives]. [2006]

3. England pubmed.ncbi.nlm.nih.gov

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

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

Opioid Consumption After Urogynecologic Surgery: A Prospective Multicenter Observational Study Using a Text-Messaging Survey Tool. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Geospatial Analyses of Pain Intensity and Opioid Unit Doses Prescribed on the Day of Discharge Following Orthopedic Surgery. [2021]

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

Reduced cognitive and psychomotor impairment with extended-release oxymorphone versus controlled-release oxycodone. [2013]

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

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

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

Opioid-related adverse drug events in surgical hospitalizations: impact on costs and length of stay. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Designing Safer Analgesics via μ-Opioid Receptor Pathways. [2018]

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

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

11. England pubmed.ncbi.nlm.nih.gov

Postoperative pain management: new, convenient analgesic therapies. [2019]

12. England pubmed.ncbi.nlm.nih.gov

Intravenous morphine and droperidol after caesarean delivery under subarachnoid anaesthesia has no effect on postoperative pain or analgesic requirements. [2013]

13. England pubmed.ncbi.nlm.nih.gov

Opioid prescribing for acute postoperative pain: an overview of systematic reviews related to two consensus statements relevant at patient, prescriber, system and public health levels. [2023]

14. New Zealand pubmed.ncbi.nlm.nih.gov

Opioid analgesics: comparative features and prescribing guidelines. [2022]

15. England pubmed.ncbi.nlm.nih.gov

Analgesic efficacy and safety of morphine-chitosan nasal solution in patients with moderate to severe pain following orthopedic surgery. [2013]