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

Status: Recruiting
Location: See location...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
New York
Hospital for Special Surgery
RECRUITING
New York
Contact Information
Primary
William Chan, MEng
chanw@hss.edu
917-260-4788
Backup
Alexandra Sideris, PhD
siderisa@hss.edu
212-774-2602
Time Frame
Start Date: 2025-10
Estimated Completion Date: 2026-12
Participants
Target number of participants: 30
Treatments
Active_comparator: Standard Opioid Pill Bottle with App
Experimental: Opioid-Dispensing Device with App
Related Therapeutic Areas
Sponsors
Leads: Hospital for Special Surgery, New York

This content was sourced from clinicaltrials.gov