Opioid Dispenser for Microdiscectomy/Laminectomy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital for Special Surgery, New York

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Opioid-Dispensing Device

    Device

    Addinex Opioid-Dispensing Device

  • App

    Other intervention

    Addinex App

  • Standard Opioid Pill Bottle

    Other intervention

    Standard Opioid Pill Bottle

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Standard Opioid Pill Bottle with AppActive comparator 2 interventions
Group B: Opioid-Dispensing Device with AppExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Hospital Discharge to Postoperative Day 14

Secondary outcomes

1

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

Time frame
PACU; Daily after Hospital Discharge: Postoperative Day 1 up to Postoperative Day 14
2

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)

Time frame
Postoperative Day 14
3

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.

Time frame
Daily up to Postoperative Day 14
4

Frequency of reported difficulties using the app

Frequency of reported difficulties using the app assessed via initiation of patient call/email to study team.

Time frame
Daily up to Postoperative Day 14

Other outcomes

Sponsors and contacts

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