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Behavioural Intervention
Smart Pill Bottles for Postoperative Pain (SPB Trial)
N/A
Waitlist Available
Led By Pascal Laferriere-Langlois, MD, MSc
Research Sponsored by Ciusss de L'Est de l'Île de Montréal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
All consenting adult patients (age >17 years) undergoing major abdominal surgery via laparotomy (any open surgery involving the abdominal compartment or its wall, excluding appendectomies, inguinal hernia repairs, abdominal wall hernia repairs, and incisional hernia repairs)
Be older than 18 years old
Must not have
Patients who do not understand French or English
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to12 months
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to see if smart pill bottles can improve data collection in clinical trials by ensuring patients take their medication correctly after surgery. Researchers will compare the data collected from the smart pill bottles to data collected
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves monitoring drug intake rather than testing new drugs, there aren't direct side effects from the intervention itself. However, participants may experience issues related to their ongoing opioid use.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am an adult who will have major surgery on my abdomen, not including simple procedures like appendectomy or hernia repairs.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not understand French or English.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Patient adherence to data collection method
Secondary study objectives
Change in Quality of Life
Prevalence of Chronic post-surgical pain 90 days after surgery
Prevalence of persistent opioid consumption 90 days after surgery
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Smart Pill Bottle Data Collection GroupExperimental Treatment1 Intervention
Group of patients in which data on postoperative opioid medication consumption will be collected through the use of smart pill bottles.
Find a Location
Who is running the clinical trial?
Ciusss de L'Est de l'Île de MontréalLead Sponsor
78 Previous Clinical Trials
6,260 Total Patients Enrolled
Pascal Laferriere-Langlois, MD, MScPrincipal InvestigatorCiusss de L'Est de l'Île de Montréal
1 Previous Clinical Trials
100 Total Patients Enrolled