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NCT06358040 · ClinicalTrials.gov registry record · NA

Opioid Dispenser for Microdiscectomy/Laminectomy

A NA study of Pain, Postoperative and Opioid Use, sponsored by Hospital for Special Surgery, New York.

Recruiting
Registry status
NA
Development phase
30
Enrollment target
1
Study location

NCT06358040: Recruiting NA study of Pain, Postoperative and Opioid Use, sponsored by Hospital for Special Surgery, New York.

NCT06358040 is a NA study of Pain, Postoperative and Opioid Use that is actively recruiting participants, run by Hospital for Special Surgery, New York. The registered enrollment target is 30 participants, below the 273-participant average among 113 other Pain, Postoperative trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06358040, a NA study of Pain, Postoperative and Opioid Use, is actively recruiting participants, sponsored by Hospital for Special Surgery, New York.

RECRUITING
Registry status
NA
Development phase
30 participants
Enrollment target
1
Study location

Study 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 fu

Primary Outcome

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.

Interventions

  • DEVICE Opioid-Dispensing Device
  • OTHER App
  • OTHER Standard Opioid Pill Bottle

Study Locations (1)

New York

  • Hospital for Special Surgery - New York

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2026-10
Est. Completion 2026-12
Phase NA

What NCT06358040 shows while recruiting

NCT06358040 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 273-participant average among 113 other Pain, Postoperative trials with a reported enrollment target (89% lower).

The record links to 5 conditions, with Pain, Postoperative appearing as the primary indexed condition, and to 3 interventions - of which Opioid-Dispensing Device is the first listed.

NCT06358040 reports a single indexed study location in New York.

Frequently Asked Questions

What is clinical trial NCT06358040 about?

NCT06358040 is a clinical study titled "Opioid Dispenser for Microdiscectomy/Laminectomy". 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 wi...

What is the current status of trial NCT06358040?

This trial is currently recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2026-10. Estimated completion is 2026-12.

What conditions does trial NCT06358040 study?

This clinical trial studies the following conditions: Pain, Postoperative, Opioid Use, Medical Device, Diskectomy, Laminectomy.

What interventions are being tested in trial NCT06358040?

The interventions under investigation include: Opioid-Dispensing Device (DEVICE), App (OTHER), Standard Opioid Pill Bottle (OTHER).

Who is sponsoring clinical trial NCT06358040?

This trial is sponsored by Hospital for Special Surgery, New York, which has 194 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06358040 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Pain, Postoperative

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06358040's enrollment target sits among peer trials

30 104th of 113 higher than 8 of 113 other Pain, Postoperative trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Pain, Postoperative trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06358040, the US trial registry maintained by the National Library of Medicine. NCT06358040 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.