Opioid Dispenser for Microdiscectomy/Laminectomy

Part of paid clinical trials in New York, New York.

Sponsor
Hospital for Special Surgery, New York
Study ID
NCT06358040
Status
Recruiting
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Conditions

  • Diskectomy
  • Laminectomy
  • Medical Device
  • Opioid Use
  • Pain, Postoperative

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Opioid-Dispensing Device — DEVICE
    Addinex Opioid-Dispensing Device
  • App — OTHER
    Addinex App
  • Standard Opioid Pill Bottle — OTHER
    Standard Opioid Pill Bottle

Study Details

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.

Key Dates

Start date
Oct 31, 2026
Status verified
Nov 2025
Primary completion
Oct 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Standard Opioid Pill Bottle with App
  • Experimental: Opioid-Dispensing Device with App

Primary Outcome Measure

Cumulative Opioid Consumption at Postoperative Day 14 (POD14) [ Time Frame: Hospital Discharge to Postoperative Day 14 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Hospital for Special SurgeryNew YorkNew York10021
William Chan, MEng
[email protected]
917-260-4788
Alexandra Sideris, PhD
[email protected]
212-774-2602

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