ClinicalTrials.gg
CompletedNCT03393364Updated Jun 11, 2020

Pain Management in Outpatient Urologic Procedures

An Early Phase 1 interventional study of Oxycodone and Ketorolac in Urologic Diseases, sponsored by University Hospitals Cleveland Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-11.

Sponsored by University Hospitals Cleveland Medical Center · Early Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Jun 2020, 6 years 4 months ago, and no results have been posted to the registry.
Phase
Early Phase 1
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Urologic Diseases

Browse trials for

03

In context

Urologic Diseases

197 studies on the registry are indexed under Urologic Diseases; 49 are open to participants now.

This study's enrollment of 150 is above the median of 80 across 138 interventional studies indexed under Urologic Diseases.

Browse Urologic Diseases studies →

Lead sponsor

University Hospitals Cleveland Medical Center is the lead sponsor of 293 studies on the registry; 43 are open to participants now.

Of its 35 completed or terminated interventional studies of FDA-regulated products, 30 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • outpatient urologic surgery
  • age 18 and over

Exclusion criteria

Exclusion Criteria:

  • renal dysfunction
  • non-English speaking
  • employees of organization
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
150 participants (actual)

Study arms

  • Experimental
    Opioid arm

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

    Drug: Oxycodone

  • Experimental
    Non-opioid arm

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

    Drug: Ketorolac

Interventions

  • Patients receive oxycodone for pain control after outpatient urologic surgery.

  • Patients receive ketorolac for pain control after outpatient urologic surgery

06

What researchers measure

Primary outcomes

  1. Pain control

    Survey evaluating how well pain was controlled

    Time frame: within 6 weeks of surgery

Secondary outcomes

  1. Number of pills used

    Survey evaluating number of pills used

    Time frame: within 6 weeks of surgery

07

Study locations

1 site
  • University Hospitals
    Cleveland, Ohio 44110, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03393364
Responsible party
Melody Chen (MD, Urology Resident, University Hospitals Cleveland Medical Center) — Principal investigator
First posted
Jan 8, 2018
Start date
Apr 1, 2018
Primary completion
Jun 1, 2020
Completion
Jun 1, 2020
Last update
Jun 11, 2020

Study contacts

Lee Ponsky, MD, MBA
study chair · University Hospitals Cleveland Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drugs tested here: Oxycodone · Ketorolac

Start the discussion