Pain Management in Outpatient Urologic Procedures

Urologic Diseases Clinical Trial

Official title:

Pain Management in Outpatient Urologic Procedures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03393364
• Other study ID #: 10-17-31
• Status: Completed
• Phase: Early Phase 1
• Start date: April 1, 2018
• Est. completion date: June 1, 2020

Study information

• Verified date: June 2020
• Source: University Hospitals Cleveland Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• outpatient urologic surgery

• age 18 and over

Exclusion Criteria:

• renal dysfunction

• non-English speaking

• employees of organization

Related Conditions & MeSH terms

• Urologic Diseases

Intervention

Drug:
• Oxycodone
Patients receive oxycodone for pain control after outpatient urologic surgery.
• Ketorolac
Patients receive ketorolac for pain control after outpatient urologic surgery

Locations

Country	Name	City	State
United States	University Hospitals	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain control	Survey evaluating how well pain was controlled	within 6 weeks of surgery
Secondary	Number of pills used	Survey evaluating number of pills used	within 6 weeks of surgery