Opioid Consumption After Hospital Discharge in Orthopedic Surgery
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|ClinicalTrials.gov Identifier: NCT03185117|
Recruitment Status : Recruiting
First Posted : June 14, 2017
Last Update Posted : April 5, 2018
|Condition or disease|
|Opioid Use Arthropathy of Knee Arthropathy of Hip|
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 :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Opioid Consumption After Hospital Discharge in Orthopedic Surgery|
|Actual Study Start Date :||September 1, 2016|
|Estimated Primary Completion Date :||September 5, 2019|
|Estimated Study Completion Date :||September 5, 2019|
Adult patients scheduled to undergo a total knee arthroplasty or total hip arthroplasty, who give written informed consent to participate in the study.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03185117
|Contact: Angela Sipes, BS, BA||614-293-3559||Angela.Sipes@osumc.edu|
|Contact: Nicoleta Stoicea, MD, PhD||614-293-0775||Nicoleta.Stoicea@osumc.edu|
|United States, Ohio|
|The Ohio State University Wexner Medical Center||Recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: Nicoleta Stoicea, MD, PhD 614-293-0775 Nicoleta.Stoicea@osumc.edu|
|Contact: Angela Sipes, BA, BS 614-293-3559 Angela.Sipes@osumc.edu|
|Principal Investigator:||Nicoleta Stoicea, MD, PhD||Ohio State University|