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Opioid Dispenser for Back Surgery Pain

This study is testing a new device, the Addinex Opioid-Dispensing Device, along with a related app, to help manage pain after back surgery (laminectomy and/or discectomy). Researchers want to see if this device can help patients use less opioid medication compared to a standard pill bottle. They will measure how much opioid medication you use up to 14 days after your surgery. You may be able to join if you are at least 18 years old, are having a specific type of elective back surgery, and are either new to opioids or use them only sometimes. The study is currently unclear about its recruitment status.

Study design
This study plans to enroll 30 participants. It is an interventional study, meaning participants will receive a specific treatment.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your opioid consumption will be measured from hospital discharge up to 14 days after surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06358040

Opioid Dispenser for Microdiscectomy/Laminectomy

Recruiting
NAAges 18+InterventionalPrevention
Hospital for Special Surgery, New York
~30 participants
Updated 2025-12-08 on ClinicalTrials.gov
What's tested:Opioid-Dispensing DeviceAppStandard Opioid Pill Bottle

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cumulative Opioid Consumption at Postoperative Day 14 (POD14)
Measured over Hospital Discharge to Postoperative Day 14

Conditions

Opioid Use
Pain, Postoperative
Medical Device
Laminectomy
Diskectomy

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Lumbar Spinal StenosisProlapsed lumbar intervertebral disc

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Vladimir Kramskiy, MD · PRINCIPAL_INVESTIGATOR · Hospital for Special Surgery, New York

Who to contact

William Chan, MEng
[email protected]
917-260-4788
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Cumulative Opioid Consumption at Postoperative Day 14 (POD14)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.