Pain Management in Outpatient Urologic Procedures
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|ClinicalTrials.gov Identifier: NCT03393364|
Recruitment Status : Recruiting
First Posted : January 8, 2018
Last Update Posted : January 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Urologic Diseases||Drug: Oxycodone Drug: Ketorolac||Early Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Opioid arm
Patients receive opioid medication, oxycodone, after outpatient urologic surgery.
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.
Patients receive ketorolac for pain control after outpatient urologic surgery
- Pain control [ Time Frame: within 6 weeks of surgery ]Survey evaluating how well pain was controlled
- Number of pills used [ Time Frame: within 6 weeks of surgery ]Survey evaluating number of pills used
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
|Contact: Melody Chen, MD||5853096932||Melody.Chen@UHHospitals.org|
|Contact: Jonathon Kiechle, MD||Jonathon.Kiechle@UHHospitals.org|
|United States, Ohio|
|Cleveland, Ohio, United States, 44110|
|Contact: Lee Ponsky, MD 216-844-3009 LeePonsky@UHHospitals.org|
|Study Chair:||Lee Ponsky, MD, MBA||University Hospitals Cleveland Medical Center|