Clinical trial NCT06358040: Opioid Dispenser for Microdiscectomy/Laminectomy
Official title: Use of a Novel Device to Dispense Postoperative Opioids in Patients Undergoing Microdiscectomy/Laminectomy: A Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Opioid Use
Pain, Postoperative
Medical Device
Laminectomy
Diskectomy
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Cumulative Opioid Consumption at Postoperative Day 14 (POD14)
timeFrame: Hospital Discharge to Postoperative Day 14
Secondary outcomes:
measure: NRS pain intensity ratings
timeFrame: PACU; Daily after Hospital Discharge: Postoperative Day 1 up to Postoperative Day 14
measure: Patient satisfaction with the app and with the dispensing device
timeFrame: Postoperative Day 14
measure: Frequency of reported difficulties using the device
timeFrame: Daily up to Postoperative Day 14
measure: Frequency of reported difficulties using the app
timeFrame: Daily up to Postoperative Day 14
measure: Opioid prescription refill rates
timeFrame: 6 weeks postoperatively
measure: Concordance of app data and medication left in the device or pill bottle (medication reconciliation)
timeFrame: Postoperative Day 14
measure: Generation of one-time use over-ride code
timeFrame: Daily up to Postoperative Day 14
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Vladimir Kramskiy, MD
role: PRINCIPAL_INVESTIGATOR
References: