Smart opioid dispenser and app for patients having a one-level lumbar discectomy or laminectomy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.