A Phase 4 interventional study of Ibuprofen 600 mg and Education in Pain, BPH With Urinary Obstruction and BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms, sponsored by Benaroya Research Institute. Recruiting at 1 site in United States. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-27.
Sponsored by Benaroya Research Institute · Phase 4, Interventional, and Treatment
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.
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.
406 studies on the registry are indexed under Lower Urinary Tract Symptoms; 110 are open to participants now.
This study's planned enrollment of 50 is below the median of 93 across 260 interventional studies indexed under Lower Urinary Tract Symptoms.
Browse Lower Urinary Tract Symptoms studies →Benaroya Research Institute is the lead sponsor of 41 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
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
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 · Behavioral: Education
We'll be adding ibuprofen while trying to limit oxycodone use while hospitalized. Patients will not be discharged with a narcotic.
We'll be adding education to patient's post-operative instructions to aid in their pain control management.
Opioid Consumption
Total opioid utilization
Time frame: PACU-72 hours
Pain Scores
Numerical Rating Scale Pain Scores (Range: 0-10, where 0 is no pain and 10 is the worst pain)
Time frame: PACU-72 hours
Presence of a foley catheter at discharge.
Was the patient discharged with a Foley catheter?
Time frame: 0-48hours
Presence of narcotic side effects
nausea/vomiting, pruritus, constipation, dizziness or feelings of sedation
Time frame: 48 hours after discharge
Were there any post-operative complications
Any complications post-operatively that occurred in the immediate post-operative setting.
Time frame: 0-48 hours
Plan to share: No — IPD will not be shared with other researchers. IPD will be used solely for this study cohort and protocol.
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