PCDD Generation 1 Oral Liquid Acetaminophen Delivery Evaluation

NCT07765238 | Not Yet Recruiting

• 1 other identifier: 2000043060
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 standard nurse-administered oral acetaminophen delivery.

Conditions

Pain Management; Postoperative Pain

Keywords

total shoulder replacement surgery

Outcome Measures

Primary Outcomes (4)

• Participant enrollment rate

  Percent participants enrolled out of all screened

  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.

  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.

  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.

  Baseline up to Day 3

Secondary Outcomes (7)

• Mean Acetaminophen consumption

  From anesthesia end time to discharge time, up to 48 hours

• Mean Opioid consumption

  From anesthesia end time to discharge time, up to 48 hours

• Mean Pain scores

  From anesthesia end time to discharge time, up to 48 hours

• Mean Time to first opioid request

  From anesthesia end time to discharge time, up to 48 hours

• Mean time to medication delivery

  From anesthesia end time to discharge time, up to 48 hours

Study Arms (2)

Acetaminophen delivery using the PCDD system

EXPERIMENTAL

Patient-controlled oral liquid acetaminophen delivery using the PCDD system in postoperative total shoulder replacement while inpatient.

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.

Interventions

PCDD Generation 1 system DEVICE

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.

Acetaminophen delivery using the PCDD system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale New Haven Hospital SRC

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Agnosia; Pain, Postoperative

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Study Officials

• Jinlei Li, MD PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinlei Li, MD PhD

CONTACT

475-434-4038; jinlei.li@yale.edu

Daniel Wiznia, MD

CONTACT

(203) 785-2579; daniel.wiznia@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: August 14, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 14, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)