- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03185117
Opioid Consumption After Hospital Discharge in Orthopedic Surgery
Study Overview
Status
Conditions
Detailed Description
After being discharged from the hospital, opioids are major source of pain relief for patients. Previous studies show that 71% of patients prescribed opioid medications after thoracic surgery admitted to taking half or less of their prescribed opioid medications. The analysis showed a correlation between the amount of opioids consumed during the patient hospitalization and after discharge. Goesling et al. surveyed patients with or without previous history of opioid use who underwent total knee arthroplasty (TKA) or total hip arthroplasty (THA). Both groups were followed for 6 months to document the "natural history" of opioid use postoperatively and post discharge. For patients with preoperative opioid use undergoing TKA, 88.5% were shown to be using opioids after 1 month, 48.2% after 3 months and 53.5% after 6 months. For patients considered opioid naïve undergoing TKA, 66.5% were shown to be using opioids after 1 month, 16.6% after 3 months and 8.2% after 6 months. For patients with preoperative opioid use undergoing THA, 63.9% were shown to be using opioids after 1 month, 37.8% after 3 months and 34.7% after 6 months. For patients considered opioid naïve undergoing THA, 22.5% were shown to be using opioids after 1 month, 4.4% after 3 months and 4.3% after 6 months.
This study is observational and involves consenting adult patients undergoing major orthopedic surgery to pre-operative assessments including the Self Administered Gerocognitive Exam (SAGE) questionnaire, a cognitive test to identify mild-moderate cognitive impairment, and collection of demographic data and medical history. Phone call follow-ups include assessments of post-discharge pain and opioid consumption, and completing verbally an adapted Activities of Daily Living questionnaire. No additional risks have been identified by participating in this study. Participants may not directly benefit from participating in this trial, but the data collected could provide valuable insight into the discrepancy between required opioid pain medications and opioid pain medication prescription for adequate pain management. This insight could then be applied to reevaluate post-discharge pain management procedures and standards of care, therefore curbing opioid use and abuse trends.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ohio
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Columbus, Ohio, United States, 43210
- The Ohio State University Wexner Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
opioid consumption over time
Time Frame: once per week, up to six weeks after surgery
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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
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once per week, up to six weeks after surgery
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nicoleta Stoicea, MD, PhD, Ohio State University
Publications and helpful links
General Publications
- Goesling 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016H0219
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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