Optimizing Pain Control in Transurethral Resection of the Prostate

September 25, 2019 updated by: Una Lee, Benaroya Research Institute
The purpose of this study is to develop a multi-modal protocol for pain management after TURP that minimizes opioid use. The investigators hypothesize this approach will provide non-inferior pain control to the current standard of care which includes opioids as the primary agent. The investigators believe this is an important step in reducing the opioid epidemic in surgical patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In our study, the investigators will randomize TURP patients to standard of care versus a multi-modal protocol. Multi-modal pain control is defined as: "analgesia that combines 2 or more agents that act by different mechanisms to provide analgesia with better pain relief and less opioids". In addition, patients in the intervention arm will receive education regarding pain control and opioid use. The investigators aim to demonstrate non-inferior pain control with this approach. The investigators hope this will inform new guidelines for pain control after TURP, minimize opioid use in this patient population, and educate physicians and patients on providing excellent pain control while minimizing the risks of opioid use. The investigators believe this could ultimately serve as a model for other endoscopic urologic procedures as well.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98101
        • Recruiting
        • Virginia Mason Medical Center
        • Sub-Investigator:
          • Dena Moskowitz, MD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Kathleen Kobashi, MD
        • Sub-Investigator:
          • Alvaro Lucioni, MD
        • Sub-Investigator:
          • Fred Govier, MD
        • Sub-Investigator:
          • Christopher Porter, MD
        • Sub-Investigator:
          • John Corman, MD
        • Sub-Investigator:
          • Thomas Pritchett, MD
        • Sub-Investigator:
          • Christopher Kuhr, MD
        • Sub-Investigator:
          • Neil Hanson, MD
        • Sub-Investigator:
          • Andrew Stamm, MD
        • Sub-Investigator:
          • Ryan Donahue, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Are identified as candidates for TURP
  • Are 18 years of age or greater
  • Are proficient in English

Exclusion Criteria:

  • Have filled an opioid prescription in the last 2 months
  • Have an allergy to a medication included in the protocol
  • Have a history of pelvic radiation
  • Have renal failure (Serum Cr > 2.0 mg/dl), peptic ulcer disease, history of gastric bypass, cirrhosis, or other contraindication precluding use of NSAID's
  • Have liver failure, hepatitis, or alcohol abuse which precludes use of acetaminophen

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard of care arm

The standard of care group will group will receive the following regimen while inpatient:

  • 2% topical lidocaine gel applied to catheter tip as needed for pain, maximum dose of 600mg in 12 hours
  • Acetaminophen 1000mg every 8 hours standing
  • Oxycodone 5mg PO every 4 hours as needed pain
  • Phenazopyridine 100mg TID as needed for urinary burning
  • Senna 1 tab every 12 hours
  • Miralax 17g powder once daily as needed for constipation

The standard of care group will get the following prescriptions on discharge:

  • Oxycodone 5mg every 4 hours as needed pain - 15 tabs
  • Acetaminophen 1000mg every 8 hours standing for two days then as needed
  • Phenazopyridine 100mg TID as needed for urinary burning - 9 tabs
  • Senna 1 tab every 12 hours - 10 tabs
Experimental: Multi-modal group

The multi-modal group will receive the following regimen while inpatient:

  • 2% topical lidocaine gel applied to catheter tip as needed for pain, maximum dose of 600mg in 12 hours
  • Acetaminophen 1000mg every 8 hours standing
  • Ibuprofen 600mg every 6 hours standing
  • Oxycodone 5mg PO every 4 hours as needed pain
  • Phenazopyridine 100mg TID as needed for urinary burning
  • Senna 1 tab every 12 hours
  • Miralax 17g powder once daily as needed for constipation
  • Patient Education (Figures 2 & 3)

The multi-modal group will receive the following prescriptions on discharge:

  • Acetaminophen 1000mg every 8 hours standing for two days then as needed - 30 tabs
  • Ibuprofen 600mg every 8 hours standing for two days then as needed - 30 tabs
  • Phenazopyridine 100mg TID as needed for urinary burning - 9 tabs
  • Senna 1 tab every 12 hours - 10 tabs
Drug: Ibuprofen 600 mg
We'll be adding ibuprofen while trying to limit oxycodone use while hospitalized. Patients will not be discharged with a narcotic.
Behavioral: Education
We'll be adding education to patient's post-operative instructions to aid in their pain control management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid Consumption
Time Frame: PACU-72 hours
Total opioid utilization
PACU-72 hours
Pain Scores
Time Frame: PACU-72 hours
Numerical Rating Scale Pain Scores (Range: 0-10, where 0 is no pain and 10 is the worst pain)
PACU-72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of a foley catheter at discharge.
Time Frame: 0-48hours
Was the patient discharged with a Foley catheter?
0-48hours
Presence of narcotic side effects
Time Frame: 48 hours after discharge
nausea/vomiting, pruritus, constipation, dizziness or feelings of sedation
48 hours after discharge
Were there any post-operative complications
Time Frame: 0-48 hours
Any complications post-operatively that occurred in the immediate post-operative setting.
0-48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benaroya Research Institute

Collaborators

Virginia Mason Hospital/Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 8, 2017

Primary Completion (Anticipated)

October 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

September 23, 2019

First Submitted That Met QC Criteria

September 23, 2019

First Posted (Actual)

September 25, 2019

Study Record Updates

Last Update Posted (Actual)

September 27, 2019

Last Update Submitted That Met QC Criteria

September 25, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB17-098

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared with other researchers. IPD will be used solely for this study cohort and protocol.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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