Optimizing Pain Control in Transurethral Resection of the Prostate

Phase 4

Recruiting

• Conditions: Pain; BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms; BPH With Urinary Obstruction
• Interventions: Drug: Ibuprofen 600 mg; Behavioral: Education

• Registration Number: NCT04102566
• Lead Sponsor: Benaroya Research Institute

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.

Study Timeline

• Study Start: 2017-12-08
• Status Verified: 2019-09
• Study First Submitted: 2019-09-23
• Study First Submitted QC: 2019-09-23
• Study First Posted: 2019-09-25
• Last Update Submitted: 2019-09-25
• Last Update Posted: 2019-09-27
• Primary Completion: 2019-10-01
• Study Completion: 2019-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multi-modal group	Ibuprofen 600 mg	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
Multi-modal group	Education	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 Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Virginia Mason Medical Center; 🇺🇸 Seattle, Washington, United States