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Can patients safely dispense their own pain medicine after surgery?

NCT ID NCT07765238

Symptom relief Sponsor: Yale University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 14, 2026 · Last updated Sep 04, 2026 · Updated 2 times

Summary

This trial tests a new device that lets patients give themselves liquid acetaminophen (a pain reliever) after total shoulder replacement surgery, instead of waiting for a nurse. The device only releases a dose when it is safe and allowed. The study will see if patients and nurses like using it, and whether it affects pain medicine use and satisfaction.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Patient-Controlled Dispenser and Deactivator (PCDD) Generation 1 system, a device that lets patients self-administer prescribed liquid acetaminophen within a dosing window.
What this could lead to
If successful, this device could offer a more convenient and satisfying way for patients to manage pain after surgery, potentially reducing reliance on nurses and opioids.
What could go wrong
This is a small pilot study, so results may not be conclusive. The device may be difficult for some patients to use, and satisfaction or pain outcomes might not improve compared to standard care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Participants * Admitted to the participating orthopedic service for elective total shoulder replacement * Received a preoperative brachial plexus block * English speaking - as on-site study members are only fluent in English * Able to independently use the PCDD system and follow basic operating instructions Nurses * Registered nurse employed at Yale New Haven Hospital. * Provides clinical care to an enrolled study participant during the participant's hospitalization. * Willing and able to provide informed consent. Exclusion Criteria: Participants * Patient refusal to participate * Pregnancy: all child bearing age patients will receive a urine screening test on the day of surgery and this result will be documented in the EMR epic. This is an elective procedure and the surgery will almost always be cancelled in the case of positive pregnancy test. In the extremely rare event the care proceeds, we will exclude the patient from the study. Emergency surgery * Cognitive impairment preventing informed consent or independent use of the device * Chronic pain requiring ongoing pain management or home opioid use * Substance use disorder * Failed preoperative brachial plexus block, defined as significant postoperative pain in the PACU requiring early escalation of analgesic management Nurses * Declines or is unwilling to provide informed consent.

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Conditions

The condition(s) this trial relates to.

agnosia Pain, Postoperative

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pain management Postoperative pain

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Yale New Haven Hospital SRC

    New Haven, Connecticut, 06520, United States

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