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Optimizing Pain Control in Transurethral Resection of the Prostate

Optimizing Pain Control in Transurethral Resection of the Prostate

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04102566
Enrollment
50
Registered
2019-09-25
Start date
2017-12-08
Completion date
2019-12-01
Last updated
2019-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

postoperative pain, Transurethral resection of the prostate, Multimodal pain control

Brief summary

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.

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.

Interventions

DRUGIbuprofen 600 mg

We'll be adding ibuprofen while trying to limit oxycodone use while hospitalized. Patients will not be discharged with a narcotic.

BEHAVIORALEducation

We'll be adding education to patient's post-operative instructions to aid in their pain control management.

Sponsors

Virginia Mason Hospital/Medical Center
CollaboratorOTHER
Benaroya Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Opioid ConsumptionPACU-72 hoursTotal opioid utilization
Pain ScoresPACU-72 hoursNumerical Rating Scale Pain Scores (Range: 0-10, where 0 is no pain and 10 is the worst pain)

Secondary

MeasureTime frameDescription
Presence of a foley catheter at discharge.0-48hoursWas the patient discharged with a Foley catheter?
Presence of narcotic side effects48 hours after dischargenausea/vomiting, pruritus, constipation, dizziness or feelings of sedation
Were there any post-operative complications0-48 hoursAny complications post-operatively that occurred in the immediate post-operative setting.

Countries

United States

Contacts

Primary ContactRyan Donahue, MD
ryan.donahue@vmmc.org2062236600

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026