NCT03393364

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Apr 2018

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 28, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 8, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

June 11, 2020

Status Verified

June 1, 2020

Enrollment Period

2.2 years

First QC Date

December 28, 2017

Last Update Submit

June 10, 2020

Conditions

Urologic Diseases

Outcome Measures

Primary Outcomes (1)

  • Pain control

    Survey evaluating how well pain was controlled

    within 6 weeks of surgery

Secondary Outcomes (1)

  • Number of pills used

    within 6 weeks of surgery

Study Arms (2)

Opioid arm

EXPERIMENTAL

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

Drug: Oxycodone

Non-opioid arm

EXPERIMENTAL

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

Drug: Ketorolac

Interventions

OxycodoneDRUG

Patients receive oxycodone for pain control after outpatient urologic surgery.

Opioid arm
KetorolacDRUG

Patients receive ketorolac for pain control after outpatient urologic surgery

Non-opioid arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • outpatient urologic surgery
  • age 18 and over

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals

Cleveland, Ohio, 44110, United States

Location

MeSH Terms

Conditions

Urologic Diseases

Interventions

OxycodoneKetorolac

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

CodeineMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsIndomethacinIndolesHeterocyclic Compounds, 2-Ring

Study Officials

  • Lee Ponsky, MD, MBA

    University Hospitals Cleveland Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Urology Resident

Study Record Dates

First Submitted

December 28, 2017

First Posted

January 8, 2018

Study Start

April 1, 2018

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

June 11, 2020

Record last verified: 2020-06

Locations

US(1)