Smart Pill Bottles for Postoperative Pain

(SPB Trial)

Not yet recruiting at 1 trial location

Overseen By Pascal Laferriere-Langlois, MD, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ciusss de L'Est de l'Île de Montréal

Must be taking: Opioids

Disqualifiers: Cognitive impairment, Others

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

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether smart pill bottles can improve data collection during clinical research. It tracks how often patients take pain medication after major abdominal surgery. The researchers aim to determine if these bottles provide better quality data than traditional methods and reduce trial costs. Participants who have undergone major open abdominal surgery and understand English or French are suitable candidates. As an unphased trial, this study allows participants to contribute to innovative research that could enhance future clinical trials.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on using a smart pill bottle for opioid medication after surgery.

What prior data suggests that the use of smart pill bottles is safe for data collection in clinical trials?

Research has shown that smart pill bottles are designed to safely track medication usage. One study found that these bottles can send alerts if they detect tampering or unsafe storage, helping to prevent misuse. Another study confirmed that monitoring opioid use with smart pill bottles is both practical and safe. No major safety issues have been reported with these bottles. They serve as a tool to track when and how medication is taken. Overall, smart pill bottles are considered a safe way to help manage medication use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about smart pill bottles for managing postoperative pain because they offer a new way to track and manage medication use. Unlike traditional pill bottles, these smart bottles automatically record when the bottle is opened, providing real-time data on opioid consumption. This helps doctors ensure patients are taking their medications correctly and can lead to more personalized pain management, potentially reducing the risk of opioid misuse. By using technology to monitor medication adherence, these smart bottles could revolutionize postoperative care and improve patient outcomes.

What evidence suggests that smart pill bottles are effective for data collection in clinical trials?

Research shows that smart pill bottles can improve tracking of medication use after surgery. In this trial, participants will join the Smart Pill Bottle Data Collection Group, where these devices will collect data on postoperative opioid medication consumption. Studies have found that smart pill bottles often gather more accurate information than traditional methods, such as patient self-reporting. For instance, smart pill bottles automatically log when a pill is taken, reducing reporting errors. Early results suggest that these bottles may help patients adhere more closely to their medication schedule. They might also save money by reducing the need for extra staff to collect data. Overall, smart pill bottles appear promising for collecting reliable information about pain medication use after surgery. ^{1 2 6 7 8}

Who Is on the Research Team?

Pascal Laferriere-Langlois, MD, MSc

Principal Investigator

Ciusss de L'Est de l'Île de Montréal

Are You a Good Fit for This Trial?

This trial is for individuals who have undergone surgery and are using opioid medication to manage postoperative pain. Participants will use a smart pill bottle for 3 months to track their medication usage. The study aims to include people who can adhere to the protocol and provide accurate data.

Inclusion Criteria

I am an adult who will have major surgery on my abdomen, not including simple procedures like appendectomy or hernia repairs.

Exclusion Criteria

Patients with diagnosed cognitive impairment

Patients enrolled in the historical cohort (POCAS study)

Patients currently participating in another study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the smart pill bottle to consume opioid medication following surgery

12 weeks

1 visit (in-person) at the start, ongoing monitoring via smart pill bottle

Follow-up

Participants are monitored for safety and effectiveness after treatment, including surveys on opioid consumption and surgical pain

4 weeks

1 visit (in-person) at the end of the 90-day period

What Are the Treatments Tested in This Trial?

Interventions

• Smart Pill Bottle

Trial Overview The trial is testing whether smart pill bottles are an effective way of collecting high-quality data on opioid consumption after surgery, while also looking at how they might reduce costs in clinical trials. Patients' adherence and the impact on cost-efficiency are key focuses.

How Is the Trial Designed?

Group I: Smart Pill Bottle Data Collection Group Experimental Treatment 1 Intervention

Group of patients in which data on postoperative opioid medication consumption will be collected through the use of smart pill bottles.

Who Is Running the Clinical Trial?

Ciusss de L'Est de l'Île de Montréal

Lead Sponsor

Trials

81

Recruited

6,400+

Published Research Related to This Trial

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]

A new cell phone application was developed to help monitor pain, medication use, and quality of life in patients with neurogenic pain, including those with limb loss, which could improve postoperative pain management.

Pilot testing with 21 participants showed that the app is quick to complete (averaging 158 seconds) and user-friendly, indicating its potential as a valuable tool for tracking pain and medication in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cell Phone Application to Monitor Pain and Quality of Life in Neurogenic Pain Patients. Sood, R., Stoehr, JR., Janes, LE., et al.[2020]

Multimechanistic approaches to postoperative pain relief, including the use of acetaminophen, can improve pain management, reduce the need for opioids, and lower the risk of opioid-related side effects, enhancing overall surgical outcomes.

Oral acetaminophen, especially when combined with opioids, has been shown to be safe and effective for managing postsurgical pain, and transitioning from intravenous to oral formulations is a reasonable strategy for continued pain control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous multimechanistic postoperative analgesia: a rationale for transitioning from intravenous acetaminophen and opioids to oral formulations. Pergolizzi, JV., Raffa, RB., Tallarida, R., et al.[2013]

The PCoA Acute patient-controlled analgesic dispenser was found to be safe and effective, with no severe adverse events reported during the study involving 70 patients across three medical centers.

Patients using the PCoA Acute took their pain medication significantly faster and reported lower pain scores compared to those receiving traditional nurse-dispensed opioids, indicating improved compliance and satisfaction with the new system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Evaluation of a Novel Technology for Oral Patient-Controlled Analgesia, the PCoA® Acute Device, for Hospitalized Patients with Postoperative Pain, in Pilot Feasibility Study. Wirz, S., Conrad, S., Shtrichman, R., et al.[2018]

A quality improvement initiative that included shared decision-making and preoperative education led to a significant reduction in opioid prescriptions, decreasing the average number of oxycodone pills prescribed from 12.29 to 6.80 per surgery (p < 0.001).

The initiative also resulted in a decrease in unused pills from 70.5% to 48.5% (p < 0.001), and increased patient satisfaction with their surgical experience, highlighting the effectiveness of personalized pain management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shared decision-making for postoperative opioid prescribing and preoperative pain management education decreases excess opioid burden. Ciampa, ML., Liang, J., O'Hara, TA., et al.[2023]

Effective management of postoperative pain is crucial as it can lead to benefits such as reduced hospital stays, lower costs, and increased patient satisfaction, but it must be personalized based on individual patient needs.

Despite the importance of pain management, it remains underutilized due to challenges like insufficient education, fear of complications from analgesics, and inadequate pain assessment methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical aspects of acute post-operative pain management & its assessment. Gupta, A., Kaur, K., Sharma, S., et al.[2022]

Citations

1. medrxiv.org medrxiv.org/content/10.1101/2024.10.23.24315929v1.full-text

Optimizing Research Data Acquisition with Smart Pill ... The primary outcome will be the percentage of patients who successfully use the SPB throughout the study period. Secondary outcomes will include ...

2. withpower.com withpower.com/trial/phase-pain-postoperative-8-2024-11282

Smart Pill Bottles for Postoperative Pain (SPB Trial) Trial Overview The trial is testing whether smart pill bottles are an effective way of collecting high-quality data on opioid consumption after surgery, while ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8328952/

Accuracy of patient-reported versus real-time electronic ... Of the 132 patients, 8 (6.1%) indicated taking more than 1 pill at a time, and 13 (9.6%) reported taking 0.5 pill between 2 and 5 times. Patient-reported use ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002961022008285

Remote smart pill cap monitoring of post-surgical pain ... Remote patient monitoring with smart pill caps is a novel way of tracking postoperative pain medication usage. •. After thyroid and parathyroid surgery, pain ...

5. researchgate.net researchgate.net/publication/385213904_Optimizing_Research_Data_Acquisition_with_Smart_Pill_Bottles_SPBs_the_ORDAS_Trial_A_Feasibility_and_Implementation_Study_Protocol

(PDF) Optimizing Research Data Acquisition with Smart Pill ... The primary outcome will be the percentage of patients who successfully use the SPB throughout the study period. Secondary outcomes will include ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8851821/

The Opioid Analgesic Reduction Study (OARS)—a ... Previous study weaknesses. Ibuprofen/acetaminophen and opioid/acetaminophen analgesic combinations are commonly prescribed after dental surgery [17–29].

7. news-medical.net news-medical.net/news/20190506/Researchers-develop-smart-pill-bottle-to-keep-drugs-safe.aspx

Researchers develop smart pill bottle to keep drugs safe A smart pill bottle that sends wireless alerts when it detects tampering, overdose or unsafe storage conditions is just one of many potential health ...

8. biospace.com biospace.com/introducing-pillsafe-r-the-new-smart-pill-bottle-for-prescription-medication

Introducing PillSafe(R), the New 'Smart' Pill Bottle for ... PillSafe is a revolutionary update, smart bottle system that secures addictive medications from the pharmacy to the patient.