Opioid UseNCT03185117
Opioid Consumption After Hospital Discharge in Orthopedic Surgery
An observational study of Opioid Use and Arthropathy of Knee, run by Ohio State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use, Arthropathy of Knee, Arthropathy of Hip
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2016to 24 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
About this study
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
Read the 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.
- Conditions
- Opioid Use, Arthropathy of Knee, Arthropathy of Hip
- Keywords
- opioid consumption, postdischarge, major orthopedic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: once per week, up to six weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start1 Sep 2016
- Primary completion24 Jul 2019
- Study completion24 Jul 2019
Why it stopped: Low patient retention rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicoleta Stoicea, Ohio State University
- Investigators
- Nicoleta Stoicea, MD, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03185117
- Sponsor's protocol ID
- 2016H0219
- Status last verified
- Oct 2021
- First submitted
- 9 Jun 2017
- Last updated
- 29 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Publications
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.
PubMed 26824844Goesling 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.
PubMed 26871536
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid Consumption After Hospital Discharge in Orthopedic Surgery
- ClinicalTrials.gov ID
- NCT03185117
- Acronym / sponsor ID
- 2016H0219
- Conditions
- Opioid Use, Arthropathy of Knee, Arthropathy of Hip
- Keywords
- opioid consumption, postdischarge, major orthopedic surgery
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low patient retention rate
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 24 Jul 2019 (actual)
- Study completion
- 24 Jul 2019 (actual)
- First posted
- 14 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
opioid consumption over time
Time frame: once per week, up to six weeks after surgery
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
Results and safety
The study was stopped early (reason given: Low patient retention rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2021.
- Background: PubMed 26824844Bartels 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.
- Background: PubMed 26871536Goesling 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.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicoleta Stoicea, MD, PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid Use and Arthropathy of Knee, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low patient retention rate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
opioid consumption over time (time frame: once per week, up to six weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03185117, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2021.