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NCT Number: NCT04102566

Optimizing Pain Control in Transurethral Resection of the Prostate

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.

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Key information

Conditions

Pain BPH With Urinary Obstruction BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms Neurologic Manifestations Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location status: Recruiting

Location contact

Alvaro Lucioni, MD

SUB_INVESTIGATOR

Andrew Stamm, MD

SUB_INVESTIGATOR

Christopher Kuhr, MD

SUB_INVESTIGATOR

Christopher Porter, MD

SUB_INVESTIGATOR

Dena Moskowitz, MD

SUB_INVESTIGATOR

Fred Govier, MD

SUB_INVESTIGATOR

John Corman, MD

SUB_INVESTIGATOR

Kathleen Kobashi, MD

SUB_INVESTIGATOR

Neil Hanson, MD

SUB_INVESTIGATOR

Ryan Donahue, MD

CONTACT

[email protected]

512-484-3214

Ryan Donahue, MD

SUB_INVESTIGATOR

Thomas Pritchett, MD

SUB_INVESTIGATOR

Una Lee, MD

CONTACT

[email protected]

2062236749

Una Lee, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Opioid Consumption

    Time frame: PACU-72 hours

    Total opioid utilization

  2. 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)

Secondary outcomes

  1. Presence of a foley catheter at discharge.

    Time frame: 0-48hours

    Was the patient discharged with a Foley catheter?

  2. Presence of narcotic side effects

    Time frame: 48 hours after discharge

    nausea/vomiting, pruritus, constipation, dizziness or feelings of sedation

  3. Were there any post-operative complications

    Time frame: 0-48 hours

    Any complications post-operatively that occurred in the immediate post-operative setting.

Study contacts

Contact information is provided by the study sponsor or research team.

Ryan Donahue, MD

CONTACT

[email protected]

2062236600

Sponsors and collaborators

Lead sponsor

Benaroya Research Institute

Other

Collaborators

  • Virginia Mason Hospital/Medical Center

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 25, 2019
Registry last updated
Sep 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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