Opioid Dispenser for Microdiscectomy/Laminectomy

NCT06358040 | Recruiting FDA Device

• 1 other identifier: 2023-0328
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• NRS pain intensity ratings

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

• Patient satisfaction with the app and with the dispensing device

  Postoperative Day 14

• Frequency of reported difficulties using the device

  Daily up to Postoperative Day 14

• Frequency of reported difficulties using the app

  Daily up to Postoperative Day 14

• Opioid prescription refill rates

  6 weeks postoperatively

Study Arms (2)

Standard Opioid Pill Bottle with App

ACTIVE COMPARATOR

Other: App; Other: Standard Opioid Pill Bottle

Opioid-Dispensing Device with App

EXPERIMENTAL

Device: Opioid-Dispensing Device; Other: App

Interventions

Opioid-Dispensing Device DEVICE

Addinex Opioid-Dispensing Device

Also known as: Addinex

Opioid-Dispensing Device with App

App OTHER

Addinex App

Also known as: Addinex

Opioid-Dispensing Device with App; Standard Opioid Pill Bottle with App

Standard Opioid Pill Bottle OTHER

Standard Opioid Pill Bottle

Standard Opioid Pill Bottle with App

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Amyloid

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Multiprotein Complexes; Macromolecular Substances; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Vladimir Kramskiy, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Central Study Contacts

William Chan, MEng

CONTACT

917-260-4788; chanw@hss.edu

Alexandra Sideris, PhD

CONTACT

212-774-2602; siderisa@hss.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2024
• First Posted: April 10, 2024
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 8, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication
• 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.

Locations

US (1)