Hospital for Special Surgery
New York, 10021, United States
Location status: Recruiting
Location contact
Alexandra Sideris, PhD
CONTACT
William Chan, MEng
CONTACT
NCT Number: NCT06358040
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
New York, 10021, United States
Location status: Recruiting
Alexandra Sideris, PhD
CONTACT
William Chan, MEng
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Addinex Opioid-Dispensing Device
Other names: Addinex
Addinex App
Other names: Addinex
Standard Opioid Pill Bottle
Time frame: Hospital Discharge to Postoperative Day 14
Cumulative Opioid Consumption at Postoperative Day 14 (POD14) following lumbar decompression (microdiscectomy/laminectomy), expressed as number of tablets and morphine equivalents (MED in mg) and collected via app starting at discharge to 14 days later.
Time frame: PACU; Daily after Hospital Discharge: Postoperative Day 1 up to Postoperative Day 14
Numerical Rating Scale (NRS) Pain Intensity Ratings from 0-10, with 0 being no pain to 10 being the worst pain possible: patient-reported in app
Time frame: Postoperative Day 14
Satisfaction survey - Device group patients will rate statements on a 5-point scale, from 1 (strongly disagree) to 5 (strongly agree)
Time frame: Daily up to Postoperative Day 14
Frequency of reported difficulties using the device assessed via initiation of patient call to study team; activation of device unlocking mechanism.
Time frame: Daily up to Postoperative Day 14
Frequency of reported difficulties using the app assessed via initiation of patient call/email to study team.
Time frame: 6 weeks postoperatively
Opioid prescription refill rates using electronic health records
Time frame: Postoperative Day 14
At Postoperative Day 14, the number of pills consumed as documented via the app, compared to actual pills left over in the device/pill bottle (telemedicine medication reconciliation).
Time frame: Daily up to Postoperative Day 14
Device group: Generation of one-time use over-ride code to dispense one opioid tablet, assessed via email to study team
Contact information is provided by the study sponsor or research team.
Alexandra Sideris, PhD
CONTACT
William Chan, MEng
CONTACT
Hospital for Special Surgery, New York
Other
Use of a Novel Device to Dispense Postoperative Opioids in Patients Undergoing Microdiscectomy/Laminectomy: A Pilot Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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