NCT03393364

Pain Management in Outpatient Urologic Procedures

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: University Hospitals Cleveland Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Urologic Diseases

Interventions

Type	Name	Description
DRUG	Oxycodone	Patients receive oxycodone for pain control after outpatient urologic surgery.
DRUG	Ketorolac	Patients receive ketorolac for pain control after outpatient urologic surgery

Timeline

• Start date: 2018-04-01
• Primary completion: 2020-06-01
• Completion: 2020-06-01
• First posted: 2018-01-08
• Last updated: 2020-06-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study