Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pain Management in Outpatient Urologic Procedures

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03393364
Recruitment Status : Recruiting
First Posted : January 8, 2018
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
Melody Chen, University Hospitals Cleveland Medical Center

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.

Condition or disease Intervention/treatment Phase
Urologic Diseases Drug: Oxycodone Drug: Ketorolac Early Phase 1

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pain Management in Outpatient Urologic Procedures
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Opioid arm
Patients receive opioid medication, oxycodone, after outpatient urologic surgery.
Drug: Oxycodone
Patients receive oxycodone for pain control after outpatient urologic surgery.

Experimental: Non-opioid arm
Patients receive a non-opioid medication, ketorolac, after outpatient urologic surgery.
Drug: Ketorolac
Patients receive ketorolac for pain control after outpatient urologic surgery




Primary Outcome Measures :
  1. Pain control [ Time Frame: within 6 weeks of surgery ]
    Survey evaluating how well pain was controlled


Secondary Outcome Measures :
  1. Number of pills used [ Time Frame: within 6 weeks of surgery ]
    Survey evaluating number of pills used



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:   Yes
Criteria

Inclusion Criteria:

  • outpatient urologic surgery
  • age 18 and over

Exclusion Criteria:

  • renal dysfunction
  • non-English speaking
  • employees of organization

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): NCT03393364


Contacts
Layout table for location contacts
Contact: Melody Chen, MD 5853096932 Melody.Chen@UHHospitals.org
Contact: Jonathon Kiechle, MD Jonathon.Kiechle@UHHospitals.org

Locations
Layout table for location information
United States, Ohio
University Hospitals Recruiting
Cleveland, Ohio, United States, 44110
Contact: Lee Ponsky, MD    216-844-3009    LeePonsky@UHHospitals.org   
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Investigators
Layout table for investigator information
Study Chair: Lee Ponsky, MD, MBA University Hospitals Cleveland Medical Center

Layout table for additonal information
Responsible Party: Melody Chen, MD, Urology Resident, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT03393364     History of Changes
Other Study ID Numbers: 10-17-31
First Posted: January 8, 2018    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
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

Additional relevant MeSH terms:
Layout table for MeSH terms
Oxycodone
Urologic Diseases
Ketorolac
Ketorolac Tromethamine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action