Smart Pill Bottles for Postoperative Pain

(SPB Trial)

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

155 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. It focuses on using a smart pill bottle for opioid medication after surgery.

What data supports the effectiveness of the Smart Pill Bottle treatment for postoperative pain?

The research on a cell phone application for monitoring pain and medication use in neurogenic pain patients suggests that technology can help manage pain and medication effectively. This implies that Smart Pill Bottles, which likely use similar technology, could also be effective in managing postoperative pain by ensuring proper medication use. ^{1 2 3 4 5}

Is the Smart Pill Bottle safe for use in humans?

The safety of patient-controlled analgesia devices, similar to Smart Pill Bottles, has been well-documented in studies, showing they are generally safe for managing postoperative pain. Some side effects like dizziness and nausea were noted, but these devices are considered safe when used properly. ^{6 7 8 9 10}

How does the Smart Pill Bottle treatment for postoperative pain differ from other treatments?

The Smart Pill Bottle treatment is unique because it likely involves a device that provides extended pain relief through controlled release, which can improve patient comfort and compliance compared to traditional methods. This approach may reduce the need for opioids by offering a flexible and reliable way to manage pain after surgery. ^{6 11 12 13 14}

What is the purpose of this trial?

The goal of this clinical trial is to learn if smart pill bottles can be used as a tool to optimize data collection in clinical trials by increasing the quality of data collected and limiting the associated cost. The main questions it aims to answer are: Is the use of smart pill bottles a feasible method of data collection in clinical trials in terms of patient adherence. Is the data collected by the smart pill bottles of higher quality than that collected through human resources? What is the impact of the use of smart pill bottles on the costs involved in clinical trials ? Researchers will collect data on postoperative opioid medication consumption with the smart pill bottle and assess the adherence of patients to the device along with the quality of data collected and the costs involved in the process. Participants will: Use the smart pill bottle to consume opioid medication following surgery for 3 months At the end of the 3 month period, the group will have filled out surveys detailing their opioid consumption, surgical pain and other relevant information.

Research Team

Pascal Laferriere-Langlois, MD, MSc

Principal Investigator

Ciusss de L'Est de l'Île de Montréal

Eligibility Criteria

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 enrolled in the historical cohort (POCAS study)

Patients with diagnosed cognitive impairment

Patients currently participating in another study

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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&#174; Acute Device, for Hospitalized Patients with Postoperative Pain, in Pilot Feasibility Study. Wirz, S., Conrad, S., Shtrichman, R., et al.[2018]

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]

References

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

Cell Phone Application to Monitor Pain and Quality of Life in Neurogenic Pain Patients. [2020]

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

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

3. France pubmed.ncbi.nlm.nih.gov

[Current trends of postoperative analgesia]. [2006]

4. Germany pubmed.ncbi.nlm.nih.gov

Shared decision-making for postoperative opioid prescribing and preoperative pain management education decreases excess opioid burden. [2023]

5. Spain pubmed.ncbi.nlm.nih.gov

Dexmedetomidine implementation in pain management in the immediate postoperative period of cardiac surgery. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Degradable polymeric vehicles for postoperative pain management. [2023]

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

Continuous multimechanistic postoperative analgesia: a rationale for transitioning from intravenous acetaminophen and opioids to oral formulations. [2013]

8. Germany pubmed.ncbi.nlm.nih.gov

[Long-term experiences with mechanical patient-controlled analgesia pumps for therapy of postoperative pain in general surgery]. [2019]

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

Clinical Evaluation of a Novel Technology for Oral Patient-Controlled Analgesia, the PCoA&#174; Acute Device, for Hospitalized Patients with Postoperative Pain, in Pilot Feasibility Study. [2018]

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

The traditional method of oral as-needed pain medication delivery compared to an oral patient-controlled analgesia device following total knee arthroplasty. [2014]

11. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Novel Targets and Drug Delivery System in the Treatment of Postoperative Pain: Recent Studies and Clinical Advancement. [2023]

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

Pain relief after major gynaecological surgery. [2019]

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

Novel pharmaceuticals in the management of postoperative pain. [2015]

14. India pubmed.ncbi.nlm.nih.gov

Clinical aspects of acute post-operative pain management & its assessment. [2022]