Opioid Dispenser for Microdiscectomy/Laminectomy

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pain, Postoperative; Opioid Use; Medical Device; Laminectomy; Diskectomy
• Intervention / Treatment: Other: App; Other: Standard Opioid Pill Bottle; Device: Opioid-Dispensing Device

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: William Chan, MEng; Phone Number: 917-260-4788; Email: chanw@hss.edu
• Study Contact Backup: Name: Alexandra Sideris, PhD; Phone Number: 212-774-2602; Email: siderisa@hss.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Recruiting
      • Hospital for Special Surgery
      • Contact: William Chan, MEng; Phone Number: 917-260-4788; Email: chanw@hss.edu
      • Contact: Alexandra Sideris, PhD; Phone Number: 212-774-2602; Email: siderisa@hss.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Opioid Pill Bottle with App	Other: App; Addinex App; Other Names: Addinex; Other: Standard Opioid Pill Bottle; Standard Opioid Pill Bottle
Experimental: Opioid-Dispensing Device with App	Other: App; Addinex App; Other Names: Addinex; Device: Opioid-Dispensing Device; Addinex Opioid-Dispensing Device; Other Names: Addinex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative Opioid Consumption at Postoperative Day 14 (POD14)	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.	Hospital Discharge to Postoperative Day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid prescription refill rates	Opioid prescription refill rates using electronic health records	6 weeks postoperatively
Frequency of reported difficulties using the device	Frequency of reported difficulties using the device assessed via initiation of patient call to study team; activation of device unlocking mechanism.	Daily up to Postoperative Day 14
Frequency of reported difficulties using the app	Frequency of reported difficulties using the app assessed via initiation of patient call/email to study team.	Daily up to Postoperative Day 14
Concordance of app data and medication left in the device or pill bottle (medication reconciliation)	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).	Postoperative Day 14
NRS pain intensity ratings	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	PACU; Daily after Hospital Discharge: Postoperative Day 1 up to Postoperative Day 14
Patient satisfaction with the app and with the dispensing device	Satisfaction survey - Device group patients will rate statements on a 5-point scale, from 1 (strongly disagree) to 5 (strongly agree)	Postoperative Day 14
Generation of one-time use over-ride code	Device group: Generation of one-time use over-ride code to dispense one opioid tablet, assessed via email to study team	Daily up to Postoperative Day 14

Collaborators and Investigators

• Sponsor: Hospital for Special Surgery, New York
• Investigators: Principal Investigator: Vladimir Kramskiy, MD, Hospital for Special Surgery, New York

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: April 5, 2024
• First Submitted That Met QC Criteria: April 5, 2024
• First Posted (Actual): April 10, 2024

Study Record Updates

• Last Update Posted (Actual): December 8, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Amino Acids, Peptides, and Proteins; Proteins; Macromolecular Substances; Multiprotein Complexes; Amyloid
• Other Study ID Numbers: 2023-0328

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication
• IPD Sharing Access Criteria: For researchers who provide a methodologically sound proposal and analyses to achieve aims in the approved proposal. Proposals should be directed to siderisa@hss.edu. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No