Study Stopped
Low patient retention rate
Opioid Consumption After Hospital Discharge in Orthopedic Surgery
1 other identifier
observational
70
1 country
1
Brief Summary
At the Ohio State University, and across the country, surgical patients admitted to the hospital are over-prescribed a significant amount of opioid medications upon discharge to home. Recent studies reveal that a large percentage of patients prescribed opioid medications after surgery have approximately half of the prescribed medication left over. This study aims to evaluate reported opioid use after surgery in patients undergoing major orthopedic surgery in order to better approach the issue with current opioid use and abuse trends while still providing adequate medical care and pain management to patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2016
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 9, 2017
CompletedFirst Posted
Study publicly available on registry
June 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 24, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 24, 2019
CompletedOctober 29, 2021
October 1, 2021
2.9 years
June 9, 2017
October 22, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
opioid consumption over time
The opioid medication (oral morphine equivalent) taken by the patients will be assessed every week until the sixth postoperative week, to compare it with the amount prescribed by the physicians
once per week, up to six weeks after surgery
Study Arms (1)
All patients
Adult patients scheduled to undergo a total knee arthroplasty or total hip arthroplasty, who give written informed consent to participate in the study.
Eligibility Criteria
Adult patients at the OSUMC, 18 years of age and older scheduled to undergo a total knee arthroplasty or total hip arthroplasty, who give written informed consent to participate in the study and who meet all inclusion and no exclusion criteria.
You may qualify if:
- Male or female, 18 years of age and older, undergoing orthopedic procedures (hip or knee arthroplasty)
- Capable and willing to consent
- Participants literate in English language
You may not qualify if:
- History of drug and /or alcohol abuse/ dependency
- Ketamine use during hospitalization
- Illiteracy
- Presence of a clinically diagnosed major psychiatric condition such as bipolar disorder, uncontrolled major depression, schizophrenia
- Any condition that the principle investigator may disqualify the patient
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
Related Publications (2)
Bartels K, Mayes LM, Dingmann C, Bullard KJ, Hopfer CJ, Binswanger IA. Opioid Use and Storage Patterns by Patients after Hospital Discharge following Surgery. PLoS One. 2016 Jan 29;11(1):e0147972. doi: 10.1371/journal.pone.0147972. eCollection 2016.
PMID: 26824844BACKGROUNDGoesling J, Moser SE, Zaidi B, Hassett AL, Hilliard P, Hallstrom B, Clauw DJ, Brummett CM. Trends and predictors of opioid use after total knee and total hip arthroplasty. Pain. 2016 Jun;157(6):1259-1265. doi: 10.1097/j.pain.0000000000000516.
PMID: 26871536BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Nicoleta Stoicea, MD, PhD
Ohio State University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Scientist/ Adj. Assistant Professor
Study Record Dates
First Submitted
June 9, 2017
First Posted
June 14, 2017
Study Start
September 1, 2016
Primary Completion
July 24, 2019
Study Completion
July 24, 2019
Last Updated
October 29, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share
Efforts will be made to keep patient information confidential. individual participant data will only be available to researchers who are approved by the Institutional Review Board (IRB) to participate in study enrollment, follow up and data analysis