Pain Management in Outpatient Urologic Procedures

NCT ID: NCT03393364

Last Updated: 2020-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2020-06-01

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.

Conditions

Urologic Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Opioid arm

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

Group Type: EXPERIMENTAL

Oxycodone

Intervention Type: DRUG

Patients receive oxycodone for pain control after outpatient urologic surgery.

Non-opioid arm

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

Group Type: EXPERIMENTAL

Ketorolac

Intervention Type: DRUG

Patients receive ketorolac for pain control after outpatient urologic surgery

Interventions

Oxycodone

Patients receive oxycodone for pain control after outpatient urologic surgery.

Intervention Type: DRUG

Ketorolac

Patients receive ketorolac for pain control after outpatient urologic surgery

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• outpatient urologic surgery
• age 18 and over

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Melody Chen

MD, Urology Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lee Ponsky, MD, MBA

Role: STUDY_CHAIR

University Hospitals Cleveland Medical Center

Locations

University Hospitals

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

10-17-31

Identifier Type: -

Identifier Source: org_study_id