Pain Management, Postoperative Pain
Conditions
Keywords
total shoulder replacement surgery
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.
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.
Interventions
DEVICEPCDD Generation 1 system
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.
Sponsors
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean score Nurse Questionnaire | Baseline up to Day 3 | Nurse satisfaction with PCDD system. Total score range 0-10 with higher scores indicating more satisfaction. |
| Participant enrollment rate | 1-7 days prior to surgery | Percent participants enrolled out of all screened |
| Retention in assigned treatment group | 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 | Baseline up to Day 3 | Patient satisfaction with PCDD system. Total score range 0-10 with higher scores indicating more satisfaction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Acetaminophen consumption | From anesthesia end time to discharge time, up to 48 hours | Postoperative acetaminophen consumption in milligrams will be monitored between anesthesia end time and discharge time. |
| Mean Opioid consumption | From anesthesia end time to discharge time, up to 48 hours | Postoperative opioid consumption in oral milligram morphine equivalent (OME) will be monitored between anesthesia end time and discharge time. |
| Mean Time to first opioid request | From anesthesia end time to discharge time, up to 48 hours | Mean time in minutes from the time when opioid medication requested by the participant to the time opioid medication is delivered |
| Mean Pain scores | From anesthesia end time to discharge time, up to 48 hours | 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. |
| Mean time to medication delivery | From anesthesia end time to discharge time, up to 48 hours | Mean time in minutes from the time when pain medication requested by the participant to the time pain medication is delivered |
| Mean awake time to assess sleep disruption related to pain control | From anesthesia end time to discharge time, up to 48 hours | Awake time (hours) at night/Sleep loss due to poor pain control |
| Mean number of pain-related nursing calls | From anesthesia end time to discharge time, up to 48 hours | Mean number of postoperative pain-related nursing calls |
Countries
United States
Contacts
CONTACTJinlei Li, MD PhD
CONTACTDaniel Wiznia, MD
PRINCIPAL_INVESTIGATORJinlei Li, MD PhD
Yale University
Outcome results
None listed