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Opioid Dispenser for Microdiscectomy/Laminectomy

RecruitingNAAges 18 Years - anyAllHospital for Special Surgery, New York
NCT06358040 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Opioid-Dispensing Device
  • App
  • Standard Opioid Pill Bottle
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Where

1 site
Hospital for Special Surgery
New York, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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