Pain ManagementNCT07765238
PCDD Generation 1 Oral Liquid Acetaminophen Delivery Evaluation
A study testing PCDD Generation 1 system in people with Pain Management and Postoperative Pain, run by Yale University at 1 site in United States.
Trial summary
This prospective randomized pilot study evaluates the feasibility, acceptability, and preliminary efficacy of the Patient-Controlled Dispenser and Deactivator (PCDD) Generation 1 system for patient-controlled oral liquid acetaminophen administration in postoperative total shoulder replacement inpatients compared with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain Management, Postoperative Pain
- What is being tested?
- PCDD Generation 1 system
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Yale New Haven Hospital SRC
New Haven, Connecticut, 06520
About this study
Official title: Evaluation of the Patient-Controlled Dispenser & Deactivator (PCDD) Generation 1 System for Oral Liquid Acetaminophen Delivery
This prospective randomized pilot study evaluates the feasibility, acceptability, and preliminary efficacy of the Patient-Controlled Dispenser and Deactivator (PCDD) Generation 1 system for patient-controlled oral liquid acetaminophen administration in postoperative total shoulder replacement inpatients compared with standard nurse-administered oral acetaminophen delivery.
Read the detailed description
The primary objective of this prospective pilot study is to determine the feasibility of patient-controlled administration of liquid oral acetaminophen using the Patient-Controlled Dispenser and Deactivator (PCDD) system, using recruitment rate and cross-over rates as surrogate markers.
The secondary objective of this study is to determine the preliminary efficacy of patient-controlled delivery of oral acetaminophen administration using the PCDD system.
- Conditions
- Pain Management, Postoperative Pain
- Being tested
- PCDD Generation 1 system
- Keywords
- total shoulder replacement surgery
- Medical subject headings
- Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCDD Generation 1 systemDevice
Dispenses prescribed oral liquid medication through a secure, patient-activated mechanism . The system provides access to as needed oral liquid doses only within the prescribed dosing eligibility window.
| Study group | Role | What they receive |
|---|---|---|
| Acetaminophen delivery using the PCDD system | Experimental | Patient-controlled oral liquid acetaminophen delivery using the PCDD system in postoperative total shoulder replacement while inpatient. Receives: Device: PCDD Generation 1 system |
| Standard nurse-administered acetaminophen | No intervention | Participants will receive standard nurse-administered as-needed acetaminophen pills in postoperative total shoulder replacement while inpatient. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant enrollment rate
Percent participants enrolled out of all screened
Measured: 1-7 days prior to surgery
Retention in assigned treatment group
Percentage of participants who remain in their assigned treatment group for the duration of study participation.
Measured: From enrollment to discharge, up to 3 days
Mean score Patient Questionnaire
Patient satisfaction with PCDD system. Total score range 0-10 with higher scores indicating more satisfaction.
Measured: Baseline up to Day 3
Mean score Nurse Questionnaire
Nurse satisfaction with PCDD system. Total score range 0-10 with higher scores indicating more satisfaction.
Measured: Baseline up to Day 3
Secondary outcomes (7)
Mean Acetaminophen consumption
Postoperative acetaminophen consumption in milligrams will be monitored between anesthesia end time and discharge time.
Measured: From anesthesia end time to discharge time, up to 48 hours
Mean Opioid consumption
Postoperative opioid consumption in oral milligram morphine equivalent (OME) will be monitored between anesthesia end time and discharge time.
Measured: From anesthesia end time to discharge time, up to 48 hours
Mean Pain scores
Participants will be asked via Pain Diary to rate their pain using numeric pain scores from 0 to 10, 0 as no pain, 10 is the worst possible.
Measured: From anesthesia end time to discharge time, up to 48 hours
Mean Time to first opioid request
Mean time in minutes from the time when opioid medication requested by the participant to the time opioid medication is delivered
Measured: From anesthesia end time to discharge time, up to 48 hours
Mean time to medication delivery
Mean time in minutes from the time when pain medication requested by the participant to the time pain medication is delivered
Measured: From anesthesia end time to discharge time, up to 48 hours
Mean awake time to assess sleep disruption related to pain control
Awake time (hours) at night/Sleep loss due to poor pain control
Measured: From anesthesia end time to discharge time, up to 48 hours
Mean number of pain-related nursing calls
Mean number of postoperative pain-related nursing calls
Measured: From anesthesia end time to discharge time, up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jinlei Li, MD PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07765238
- Sponsor's protocol ID
- 2000043060
- Status last verified
- Sep 2026
- First submitted
- 10 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Patient-Controlled Dispenser & Deactivator (PCDD) Generation 1 System for Oral Liquid Acetaminophen Delivery
- ClinicalTrials.gov ID
- NCT07765238
- Acronym / sponsor ID
- 2000043060
- Conditions
- Pain Management, Postoperative Pain
- Keywords
- total shoulder replacement surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 14 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective randomized pilot study evaluates the feasibility, acceptability, and preliminary efficacy of the Patient-Controlled Dispenser and Deactivator (PCDD) Generation 1 system for patient-controlled oral liquid acetaminophen administration in postoperative total shoulder replacement inpatients compared with standard nurse-administered oral acetaminophen delivery.
Detailed description
The primary objective of this prospective pilot study is to determine the feasibility of patient-controlled administration of liquid oral acetaminophen using the Patient-Controlled Dispenser and Deactivator (PCDD) system, using recruitment rate and cross-over rates as surrogate markers.
The secondary objective of this study is to determine the preliminary efficacy of patient-controlled delivery of oral acetaminophen administration using the PCDD system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acetaminophen delivery using the PCDD system | Experimental | Device: PCDD Generation 1 systemPatient-controlled oral liquid acetaminophen delivery using the PCDD system in postoperative total shoulder replacement while inpatient. |
| Standard nurse-administered acetaminophen | No intervention | –Participants will receive standard nurse-administered as-needed acetaminophen pills in postoperative total shoulder replacement while inpatient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCDD Generation 1 systemDispenses prescribed oral liquid medication through a secure, patient-activated mechanism . The system provides access to as needed oral liquid doses only within the prescribed dosing eligibility window. | Device | Acetaminophen delivery using the PCDD system |
Primary outcome
Participant enrollment rate
Time frame: 1-7 days prior to surgery
Percent participants enrolled out of all screened
Retention in assigned treatment group
Time frame: From enrollment to discharge, up to 3 days
Percentage of participants who remain in their assigned treatment group for the duration of study participation.
Mean score Patient Questionnaire
Time frame: Baseline up to Day 3
Patient satisfaction with PCDD system. Total score range 0-10 with higher scores indicating more satisfaction.
Mean score Nurse Questionnaire
Time frame: Baseline up to Day 3
Nurse satisfaction with PCDD system. Total score range 0-10 with higher scores indicating more satisfaction.
7 secondary outcomes
Mean Acetaminophen consumption
Time frame: From anesthesia end time to discharge time, up to 48 hours
Mean Opioid consumption
Time frame: From anesthesia end time to discharge time, up to 48 hours
Mean Pain scores
Time frame: From anesthesia end time to discharge time, up to 48 hours
Mean Time to first opioid request
Time frame: From anesthesia end time to discharge time, up to 48 hours
Mean time to medication delivery
Time frame: From anesthesia end time to discharge time, up to 48 hours
Mean awake time to assess sleep disruption related to pain control
Time frame: From anesthesia end time to discharge time, up to 48 hours
Mean number of pain-related nursing calls
Time frame: From anesthesia end time to discharge time, up to 48 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jinlei Li, MD PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PCDD Generation 1 system in people with Pain Management and Postoperative Pain, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jinlei Li, MD PhD (475-434-4038, jinlei.li@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant enrollment rate (time frame: 1-7 days prior to surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.