Optimizing Pain Control in Transurethral Resection of the Prostate

Study Overview
=================
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.

Official Title
-----------------
Optimizing Pain Control in Transurethral Resection of the Prostate

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

Intervention / Treatment
-----------------
* Drug: Ibuprofen 600 mg
* Behavioral: Education


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of care arm<br>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<br>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<br>* We'll be adding ibuprofen while trying to limit oxycodone use while hospitalized. Patients will not be discharged with a narcotic.<br>Behavioral: Education<br>* We'll be adding education to patient's post-operative instructions to aid in their pain control management.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postoperative pain, Transurethral resection of the prostate, Multimodal pain control