Opioid Dispenser for Microdiscectomy/Laminectomy

Launched by HOSPITAL FOR SPECIAL SURGERY, NEW YORK · Apr 5, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new device designed to help patients manage their use of opioid medications safely after spine surgery, specifically procedures called laminectomy and discectomy. The goal is to find out if this device can help patients take their pain medications in a way that reduces the risk of addiction and side effects. In the study, 30 patients who are having this type of surgery will be divided into two groups. One group will receive their opioids in a standard pill bottle, while the other group will get the new opioid dispenser, which only allows access to the medication at certain times through a mobile app. Participants will track their pain and medication use for two weeks after surgery.

To be eligible for this trial, participants must be at least 18 years old and not have used opioids regularly in the past three months. They should be planning to have a specific type of spine surgery and be discharged home the same day. Patients who are allergic to opioids, pregnant, or have certain other conditions will not be included in the study. Throughout the trial, participants will share their experiences using the device and provide information about their pain and leftover pills during telehealth sessions. This research aims to see if the new device can help patients manage pain more effectively and safely after surgery.

Gender

ALL

Eligibility criteria

• 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