Optimizing Pain Control in Transurethral Resection of the Prostate

Part of paid clinical trials in Seattle, Washington.

Sponsor
Benaroya Research Institute
Study ID
NCT04102566
Phase
PHASE4
Status
Recruiting
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Conditions

  • BPH With Urinary Obstruction
  • BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms
  • Pain

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Ibuprofen 600 mg — DRUG
    We'll be adding ibuprofen while trying to limit oxycodone use while hospitalized. Patients will not be discharged with a narcotic.
  • Education — BEHAVIORAL
    We'll be adding education to patient's post-operative instructions to aid in their pain control management.

Study Details

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.

Key Dates

Start date
Dec 8, 2017
Status verified
Sep 2019
Primary completion
Oct 1, 2019
Completion
Dec 1, 2019

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Opioid Consumption [ Time Frame: PACU-72 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Virginia Mason Medical CenterSeattleWashington98101
Ryan Donahue, MD
[email protected]
512-484-3214
Una Lee, MD
[email protected]
2062236749
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)
Dena Moskowitz, MD (SUB_INVESTIGATOR)
Neil Hanson, MD (SUB_INVESTIGATOR)
Andrew Stamm, MD (SUB_INVESTIGATOR)
Ryan Donahue, MD (SUB_INVESTIGATOR)
Una Lee, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Virginia Mason Medical Center· Seattle, WA

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