protocolSection identificationModule nctId: NCT06358040, orgStudyIdInfo id: 2023-0328, briefTitle: Opioid Dispenser for Microdiscectomy/Laminectomy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Hospital for Special Surgery, New York, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Opioid Use, conditions: Pain, Postoperative, conditions: Medical Device, conditions: Laminectomy, conditions: Diskectomy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Opioid-Dispensing Device, interventions name: App, interventions name: Standard Opioid Pill Bottle, outcomesModule primaryOutcomes measure: Cumulative Opioid Consumption at Postoperative Day 14 (POD14), secondaryOutcomes measure: NRS pain intensity ratings, secondaryOutcomes measure: Patient satisfaction with the app and with the dispensing device, secondaryOutcomes measure: Frequency of reported difficulties using the device, secondaryOutcomes measure: Frequency of reported difficulties using the app, secondaryOutcomes measure: Opioid prescription refill rates, secondaryOutcomes measure: Concordance of app data and medication left in the device or pill bottle (medication reconciliation), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital for Special Surgery, city: New York, state: New York, zip: 10021, country: United States, contacts name: William Chan, MEng, role: CONTACT, phone: 917-260-4788, email: chanw@hss.edu, contacts name: Alexandra Sideris, PhD, role: CONTACT, phone: 212-774-2602, email: siderisa@hss.edu, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False