PCDD System for Postoperative Pain

JL
DW
Overseen ByDaniel Wiznia, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

JL

Jinlei Li, MD PhD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for adults recovering in the hospital after total shoulder replacement surgery who need acetaminophen for pain. Participants must be able to use a patient-controlled device and follow instructions.

Inclusion Criteria

Participants English speaking as on-site study members are only fluent in English
I am scheduled for a planned total shoulder replacement surgery.
Nurses registered nurse employed at Yale New Haven Hospital
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Exclusion Criteria

Participants chronic pain requiring ongoing pain management or home opioid use
Participants substance use disorder
I do not wish to take part in this study.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-7 days

Treatment

Participants receive either patient-controlled oral liquid acetaminophen using the PCDD system or standard nurse-administered acetaminophen during their inpatient stay post-surgery

Up to 3 days
Inpatient stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including satisfaction and pain management assessments

Up to 48 hours post-treatment

What Are the Treatments Tested in This Trial?

Interventions

  • PCDD Generation 1 system

Trial Overview

The study compares a new system that lets patients control their own doses of liquid acetaminophen with the usual method where nurses give the medicine, to see which works better and is more acceptable.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Acetaminophen delivery using the PCDD systemExperimental Treatment1 Intervention
Group II: Standard nurse-administered acetaminophenActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials
1,963
Recruited
3,046,000+