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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

Tracking Information
First Submitted Date January 24, 2017
First Posted Date January 26, 2017
Last Update Posted Date April 9, 2018
Actual Study Start Date January 17, 2018
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 24, 2017)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Opioid Consumption in Cystectomy Patients
Official Title Opioid Consumption After Hospital Discharge in Cystectomy Patients
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.
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
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Cystostomy; Complications
  • Opioid Use
Intervention Not Provided
Study Groups/Cohorts All Patients
All cystectomy patients who consent for the study
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: January 24, 2017)
80
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03032822
Other Study ID Numbers 2017H0430
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
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.
Responsible Party Tristan Weaver, Ohio State University
Study Sponsor Ohio State University
Collaborators Not Provided
Investigators
Principal Investigator: Tristan E Weaver, MD Ohio State University
PRS Account Ohio State University
Verification Date April 2018