Opioid Dispenser for Microdiscectomy/Laminectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Opioid-Dispensing Device, App, Standard Opioid Pill Bottle.
- Who it may be relevant to
- Registry conditions: Opioid Use, Pain, Postoperative, Medical Device, Laminectomy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Use of a Novel Device to Dispense Postoperative Opioids in Patients Undergoing Microdiscectomy/Laminectomy: A Pilot Study
Overview
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.
Interventions
- Device Opioid-Dispensing Device
Addinex Opioid-Dispensing Device - Other App
Addinex App - Other Standard Opioid Pill Bottle
Standard Opioid Pill Bottle
Primary outcome measures
- Cumulative Opioid Consumption at Postoperative Day 14 (POD14) [Time frame: Hospital Discharge to Postoperative Day 14]
Secondary outcome measures (7)
- NRS pain intensity ratings [Time frame: PACU; Daily after Hospital Discharge: Postoperative Day 1 up to Postoperative Day 14]
- Patient satisfaction with the app and with the dispensing device [Time frame: Postoperative Day 14]
- Frequency of reported difficulties using the device [Time frame: Daily up to Postoperative Day 14]
- Frequency of reported difficulties using the app [Time frame: Daily up to Postoperative Day 14]
- Opioid prescription refill rates [Time frame: 6 weeks postoperatively]
- Concordance of app data and medication left in the device or pill bottle (medication reconciliation) [Time frame: Postoperative Day 14]
- Generation of one-time use over-ride code [Time frame: Daily up to Postoperative Day 14]
Eligibility criteria
Inclusion criteria
- opioid-naive patients or intermittent opioid users within 3 months of scheduled surgery
- At least 18 years old
- presenting for primary elective one-level lumbar laminectomy and/or discectomy via posterior approach with participating surgeon
- planned discharge on day of surgery/23 hour admission
- planned discharge to home
Exclusion criteria
- patients with opioid-tolerance
- patients without a smart-phone or without the ability to perform Telehealth visits
- patients unable to utilize the medication dispensing device
- patients presenting for other surgeries/surgeries with combined anterior/lateral approaches
- patient refusal
- allergy or intolerance to opioids
- planned admission after surgery
- planned discharge disposition to nursing facility or skilled rehabilitation
- planned use of or preference for opioid other than oxycodone
- patients who are pregnant
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Hospital for Special Surgery — New York
Identifiers
NCT: NCT06358040 · 2023-0328