Pain Management in Outpatient Urologic Procedures

University Hospitals (UH)

Status and phase: Completed; Early Phase 1

Conditions: Urologic Diseases

Treatments: Drug: Oxycodone; Drug: Ketorolac

Study type: Interventional

Funder types: Other

Identifiers

NCT03393364

10-17-31

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• outpatient urologic surgery
• age 18 and over

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Opioid arm

Experimental group

Description:

Patients receive opioid medication, oxycodone, after outpatient urologic surgery.

Treatment:

Drug: Oxycodone

Non-opioid arm

Experimental group

Description:

Patients receive a non-opioid medication, ketorolac, after outpatient urologic surgery.

Treatment:

Drug: Ketorolac