Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Opioid Consumption in Cystectomy Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03032822
Recruitment Status : Unknown
Verified April 2018 by Tristan Weaver, Ohio State University.
Recruitment status was:  Recruiting
First Posted : January 26, 2017
Last Update Posted : April 9, 2018
Sponsor:
Information provided by (Responsible Party):
Tristan Weaver, 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 cystectomy 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
Cystostomy; Complications Opioid Use

Detailed Description:
Previous studies show that 67% of patients prescribed opioid medications in urologic procedures and surgeries had leftover opioid medications with a mean use of about half the medications prescribed. A similar study in thoracic surgery patients reported similar results with 71% of patients admitting to taking half or less of their prescribed opioid medications. Recent advancements in cystectomy protocol have already shown promise with reducing hospital length of stay from eight to four days, including the simultaneous reduction of opioid analgesics for pain management, with 4.9 mg morphine equivalents per day when using enhanced recovery techniques compared to 20.67 mg in traditional care. Results of the current prospective study could further support these results and include low to no risk assessments and follow-up phone calls. This study is observational and involves consenting adult patients undergoing cystectomy 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

Layout table for study information
Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Opioid Consumption After Hospital Discharge in Cystectomy Patients
Actual Study Start Date : January 17, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Group/Cohort
All Patients
All cystectomy patients who consent for 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 cystecotomy, who give written informed consent to participate in the study and who meet all inclusion and no exclusion criteria
Criteria

Inclusion Criteria:

  • patients undergoing cystectomy
  • 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): NCT03032822


Contacts
Layout table for location contacts
Contact: January Kim 614-293-3559 january.kim@osumc.edu
Contact: Nicoleta Stoicea, MD, PhD 614-293-0775 Nicoleta.Stoicea@osumc.edu

Locations
Layout table for location information
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, BS, BA    614-293-3559    Angela.Sipes@osumc.edu   
Sponsors and Collaborators
Ohio State University
Investigators
Layout table for investigator information
Principal Investigator: Tristan E Weaver, MD Ohio State University
Layout table for additonal information
Responsible Party: Tristan Weaver, Assistant Professor - Clinical, Ohio State University
ClinicalTrials.gov Identifier: NCT03032822    
Other Study ID Numbers: 2017H0430
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: April 2018
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.
Keywords provided by Tristan Weaver, Ohio State University:
Opioid consumption
postdischarge
cystectomy