Pain Management in Outpatient Urologic Procedures
Primary Purpose
Urologic Diseases
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Oxycodone
Ketorolac
Sponsored by
About this trial
This is an interventional treatment trial for Urologic Diseases
Eligibility Criteria
Inclusion Criteria:
- outpatient urologic surgery
- age 18 and over
Exclusion Criteria:
- renal dysfunction
- non-English speaking
- employees of organization
Sites / Locations
- University Hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Opioid arm
Non-opioid arm
Arm Description
Patients receive opioid medication, oxycodone, after outpatient urologic surgery.
Patients receive a non-opioid medication, ketorolac, after outpatient urologic surgery.
Outcomes
Primary Outcome Measures
Pain control
Survey evaluating how well pain was controlled
Secondary Outcome Measures
Number of pills used
Survey evaluating number of pills used
Full Information
NCT ID
NCT03393364
First Posted
December 28, 2017
Last Updated
June 10, 2020
Sponsor
University Hospitals Cleveland Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03393364
Brief Title
Pain Management in Outpatient Urologic Procedures
Official Title
Pain Management in Outpatient Urologic Procedures
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
June 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospitals Cleveland Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Goal of this study is to evaluate how pain is controlled after outpatient urologic surgeries. Patients will receive either opioid pain medication or non-opioid medication for pain control. A survey will be conducted at the post-operative appointment to evaluate for pain control.
Detailed Description
Patients will be approached in the pre-operative area prior to their outpatient urologic surgery. Informed Consent will be obtained at that time. Patients will be instructed that they will receive a prescription for either opioid pain medication or non-opioid medication for after surgery. The opioid medication includes oxycodone, while the non-opioid includes ketoralac, a non-steroidal anti-inflammatory medication. Subjects will be assigned randomly to either medication. Standard of care after outpatient urologic surgery is either oxycodone or ketoralac, however there is no previous research on whether one is superior than the other. These drugs were chosen because they are the most commonly used medications after outpatient urologic surgery. The study team and patients will not be blinded to the treatment.
They will also receive instructions for non-opioid pain management. If the patients require additional pain medication after surgery, they are instructed to call the provider's office for further evaluation and treatment. The patient's physician will prescribe further medication if warranted. The post-operative appointment is scheduled 2-3 weeks after surgery. At the post-operative appointment, patients will then be given a four question paper survey inquiring how well their pain was managed, how many pills were taken, if any additional non-opioid medications were taken for pain, and how the extra pills were disposed. Other PHI that will be collected includes patient's age, gender, past medical history, past surgical history, renal function, prior medications, and current surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urologic Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Opioid arm
Arm Type
Experimental
Arm Description
Patients receive opioid medication, oxycodone, after outpatient urologic surgery.
Arm Title
Non-opioid arm
Arm Type
Experimental
Arm Description
Patients receive a non-opioid medication, ketorolac, after outpatient urologic surgery.
Intervention Type
Drug
Intervention Name(s)
Oxycodone
Intervention Description
Patients receive oxycodone for pain control after outpatient urologic surgery.
Intervention Type
Drug
Intervention Name(s)
Ketorolac
Intervention Description
Patients receive ketorolac for pain control after outpatient urologic surgery
Primary Outcome Measure Information:
Title
Pain control
Description
Survey evaluating how well pain was controlled
Time Frame
within 6 weeks of surgery
Secondary Outcome Measure Information:
Title
Number of pills used
Description
Survey evaluating number of pills used
Time Frame
within 6 weeks of surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
outpatient urologic surgery
age 18 and over
Exclusion Criteria:
renal dysfunction
non-English speaking
employees of organization
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lee Ponsky, MD, MBA
Organizational Affiliation
University Hospitals Cleveland Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospitals
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44110
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Pain Management in Outpatient Urologic Procedures
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