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NCT Number: NCT06358040

Opioid Dispenser for Microdiscectomy/Laminectomy

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Opioid-Dispensing Device

Device

Addinex Opioid-Dispensing Device

Other names: Addinex

App

Other

Addinex App

Other names: Addinex

Standard Opioid Pill Bottle

Other

Standard Opioid Pill Bottle

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

  1. NRS pain intensity ratings

    Time frame: PACU; Daily after Hospital Discharge: Postoperative Day 1 up to Postoperative Day 14

    Numerical Rating Scale (NRS) Pain Intensity Ratings from 0-10, with 0 being no pain to 10 being the worst pain possible: patient-reported in app

  2. Patient satisfaction with the app and with the dispensing device

    Time frame: Postoperative Day 14

    Satisfaction survey - Device group patients will rate statements on a 5-point scale, from 1 (strongly disagree) to 5 (strongly agree)

  3. Frequency of reported difficulties using the device

    Time frame: Daily up to Postoperative Day 14

    Frequency of reported difficulties using the device assessed via initiation of patient call to study team; activation of device unlocking mechanism.

  4. Frequency of reported difficulties using the app

    Time frame: Daily up to Postoperative Day 14

    Frequency of reported difficulties using the app assessed via initiation of patient call/email to study team.

  5. Opioid prescription refill rates

    Time frame: 6 weeks postoperatively

    Opioid prescription refill rates using electronic health records

  6. Concordance of app data and medication left in the device or pill bottle (medication reconciliation)

    Time frame: Postoperative Day 14

    At Postoperative Day 14, the number of pills consumed as documented via the app, compared to actual pills left over in the device/pill bottle (telemedicine medication reconciliation).

  7. Generation of one-time use over-ride code

    Time frame: Daily up to Postoperative Day 14

    Device group: Generation of one-time use over-ride code to dispense one opioid tablet, assessed via email to study team

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandra Sideris, PhD

CONTACT

[email protected]

212-774-2602

William Chan, MEng

CONTACT

[email protected]

917-260-4788

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Official study title

Use of a Novel Device to Dispense Postoperative Opioids in Patients Undergoing Microdiscectomy/Laminectomy: A Pilot Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 10, 2024
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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