Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06358040

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

Led by Hospital for Special Surgery, New York · Updated on 2025-12-08

30

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The opioid crisis in the United States remains a major concern, especially regarding the safe and responsible use of opioid medications after surgery. This trial focuses on patients undergoing spine surgery who often receive opioids for pain relief. While opioids can effectively manage pain, they may cause side effects ranging from minor issues like nausea to severe problems such as abnormal breathing or addiction. This study aims to evaluate a new device designed to help patients take opioids more safely after surgery. Participants in this randomized trial will be divided into two groups. One group will receive a standard opioid pill bottle along with a mobile app to record daily pain scores and opioid use for two weeks after surgery. The other group will use a new opioid-dispensing device that requires a passcode generated by the app after entering their pain score, controlling when they can access their medication. The study will track opioid use and pain scores daily and assess patient satisfaction with the device after 14 days. Throughout the study, researchers will monitor opioid consumption, pain intensity, and any difficulties using the app or device. On day 14, they will conduct a telehealth session to count leftover pills and gather feedback. Additional assessments include tracking prescription refills up to six weeks post-surgery and verifying medication records. The study's total duration for participants is two weeks, focusing on postoperative opioid use and patient experience with these technologies.

CONDITIONS

Brief Title

Opioid Dispenser for Microdiscectomy/Laminectomy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Opioid-naive patients or intermittent opioid users within 3 months before surgery
  • At least 18 years old
  • Scheduled for primary elective one-level lumbar laminectomy and/or discectomy via posterior approach with participating surgeon
  • Planned discharge on day of surgery or after up to 23 hours admission
  • Planned discharge to home
Not Eligible

You will not qualify if you...

  • Patients with opioid tolerance
  • Patients without a smartphone or unable to participate in telehealth visits
  • Patients unable to use the medication dispensing device
  • Patients scheduled for other surgeries or surgeries with combined anterior/lateral approaches
  • Patient refusal to participate
  • Allergy or intolerance to opioids
  • Planned admission after surgery
  • Planned discharge to nursing facility or skilled rehabilitation
  • Planned use or preference for opioids other than oxycodone
  • Pregnant patients

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Surgery and Immediate Post-operative Care

Duration - Up to 23 hours admission or day of surgery discharge

Participants undergo microdiscectomy or laminectomy surgery and receive immediate post-operative care.

1 surgical visit (in-person)

Post-operative Follow-up

Duration - 14 days after hospital discharge

Participants use either the opioid-dispensing device with app or standard opioid pill bottle with app to manage their opioid medications and report on pain and device/app usage.

Daily visits for up to 14 days

Follow-up

Duration - 6 weeks postoperatively

Participants are monitored for opioid prescription refill rates and overall recovery after the initial 14-day post-operative period.

1 visit (in-person or remote)

Trial Site Locations

Total: 1 location

1

Hospital for Special Surgery

New York, New York, United States, 10021

Actively Recruiting

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Research Team

W

William Chan, MEng

A

Alexandra Sideris, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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