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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
Sponsor:
Information provided by (Responsible Party):
Nicoleta Stoicea, Ohio State University

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

Condition or disease
Opioid Use Arthropathy of Knee Arthropathy of Hip

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 : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.
Criteria

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

Information from the National Library of Medicine

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


Contacts
Contact: Angela Sipes, BS, BA 614-293-3559 Angela.Sipes@osumc.edu
Contact: Nicoleta Stoicea, MD, PhD 614-293-0775 Nicoleta.Stoicea@osumc.edu

Locations
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   
Sponsors and Collaborators
Ohio State University
Investigators
Principal Investigator: Nicoleta Stoicea, MD, PhD Ohio State University

Publications:
Responsible Party: Nicoleta Stoicea, Research Scientist/ Adj. Assistant Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT03185117     History of Changes
Other Study ID Numbers: 2016H0219
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nicoleta Stoicea, Ohio State University:
opioid consumption
postdischarge
major orthopedic surgery

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents