Opioid Dispenser for Microdiscectomy/Laminectomy

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06358040
• Other study ID #: 2023-0328
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: September 2025

Study information

• Verified date: May 2024
• Source: Hospital for Special Surgery, New York
• Contact: William Chan, MEng
• Phone: 917-260-4788
• Email: chanw[@]hss.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Opioid-Dispensing Device
Addinex Opioid-Dispensing Device

Other:
• App
Addinex App
• Standard Opioid Pill Bottle
Standard Opioid Pill Bottle

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	NRS pain intensity ratings	Numerical Rating Scale (NRS) Pain Intensity Ratings from 0-10, with 0 being no pain to 10 being the worst pain possible: patient-reported in app	PACU; Daily after Hospital Discharge: Postoperative Day 1 up to Postoperative Day 14
Secondary	Patient satisfaction with the app and with the dispensing device	Satisfaction survey - Device group patients will rate statements on a 5-point scale, from 1 (strongly disagree) to 5 (strongly agree)	Postoperative Day 14
Secondary	Frequency of reported difficulties using the device	Frequency of reported difficulties using the device assessed via initiation of patient call to study team; activation of device unlocking mechanism.	Daily up to Postoperative Day 14
Secondary	Frequency of reported difficulties using the app	Frequency of reported difficulties using the app assessed via initiation of patient call/email to study team.	Daily up to Postoperative Day 14
Secondary	Opioid prescription refill rates	Opioid prescription refill rates using electronic health records	6 weeks postoperatively
Secondary	Concordance of app data and medication left in the device or pill bottle (medication reconciliation)	At Postoperative Day 14, the number of pills consumed as documented via the app, compared to actual pills left over in the device/pill bottle (telemedicine medication reconciliation).	Postoperative Day 14
Secondary	Generation of one-time use over-ride code	Device group: Generation of one-time use over-ride code to dispense one opioid tablet, assessed via email to study team	Daily up to Postoperative Day 14