Smart opioid dispenser and app for patients having a one-level lumbar discectomy or laminectomy
Use of a Novel Device to Dispense Postoperative Opioids in Patients Undergoing Microdiscectomy/Laminectomy: A Pilot Study
This test tries a locked opioid-dispensing device plus a smartphone app to help adults having a one-level lumbar discectomy or laminectomy who are opioid-naive or occasional users take oxycodone more safely after discharge.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital for Special Surgery, New York Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06358040 on ClinicalTrials.gov |
What this trial studies
This interventional study compares a locked opioid-dispensing device paired with a smartphone app to the standard opioid pill bottle for adults undergoing primary elective one-level posterior lumbar laminectomy or discectomy. Eligible participants who are opioid-naive or intermittent users and planned for same-day or 23-hour discharge will receive oxycodone dispensed either by the device with app-based instructions and telehealth follow-up or by the usual pill bottle. Investigators will monitor opioid consumption, adherence to dosing, side effects, and safe storage and disposal behaviors after surgery. The trial aims to determine whether the device and app reduce unsafe use, leftover pills, and opioid-related adverse events in the postoperative period.
Who should consider this trial
Good fit: Adults 18 or older who are opioid-naive or intermittent users within the past three months, scheduled for a primary elective one-level posterior lumbar laminectomy or discectomy with planned same-day or 23-hour discharge, who have a smartphone and can use the dispensing device are ideal candidates.
Not a fit: Patients who are opioid-tolerant, unable to use a smartphone or the dispensing device, pregnant, allergic to oxycodone, planned for inpatient admission or discharge to a facility, or who require a different opioid are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could reduce unsafe opioid use and leftover pills after spinal surgery while improving adherence to prescribed dosing and patient safety.
How similar studies have performed: Previous smaller studies of locked dispensers and app-based opioid education in other surgical populations have shown reduced leftover pills and improved adherence, but applying this approach specifically after lumbar discectomy/laminectomy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New York, New York
- Hospital for Special Surgery — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Vladimir Kramskiy, MD — Hospital for Special Surgery, New York
- Study coordinator: William Chan, MEng
- Email: chanw@hss.edu
- Phone: 917-260-4788
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.