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.

Study Overview

• Status: Unknown
• Conditions: Pain; BPH With Urinary Obstruction; BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms
• Intervention / Treatment: Drug: Ibuprofen 600 mg; Behavioral: Education

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ryan Donahue, MD; Phone Number: 2062236600; Email: ryan.donahue@vmmc.org

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98101
      • Recruiting
      • Virginia Mason Medical Center
      • Sub-Investigator: Dena Moskowitz, MD
      • Contact: Ryan Donahue, MD; Phone Number: 512-484-3214; Email: ryan.donahue@vmmc.org
      • Contact: Una Lee, MD; Phone Number: 2062236749; Email: una.lee@vmmc.org
      • Sub-Investigator: Kathleen Kobashi, MD
      • Sub-Investigator: Alvaro Lucioni, MD
      • Sub-Investigator: Fred Govier, MD
      • Sub-Investigator: Christopher Porter, MD
      • Sub-Investigator: John Corman, MD
      • Sub-Investigator: Thomas Pritchett, MD
      • Sub-Investigator: Christopher Kuhr, MD
      • Sub-Investigator: Neil Hanson, MD
      • Sub-Investigator: Andrew Stamm, MD
      • Sub-Investigator: Ryan Donahue, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Benaroya Research Institute
• Collaborators: Virginia Mason Hospital/Medical Center

Publications and helpful links

General Publications

• Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain--United States, 2016. JAMA. 2016 Apr 19;315(15):1624-45. doi: 10.1001/jama.2016.1464.
• Hill MV, McMahon ML, Stucke RS, Barth RJ Jr. Wide Variation and Excessive Dosage of Opioid Prescriptions for Common General Surgical Procedures. Ann Surg. 2017 Apr;265(4):709-714. doi: 10.1097/SLA.0000000000001993.
• Sun EC, Darnall BD, Baker LC, Mackey S. Incidence of and Risk Factors for Chronic Opioid Use Among Opioid-Naive Patients in the Postoperative Period. JAMA Intern Med. 2016 Sep 1;176(9):1286-93. doi: 10.1001/jamainternmed.2016.3298. Erratum In: JAMA Intern Med. 2016 Sep 1;176(9):1412. JAMA Intern Med. 2022 Jun 1;182(6):690. JAMA Intern Med. 2022 Jul 1;182(7):783.
• American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012 Feb;116(2):248-73. doi: 10.1097/ALN.0b013e31823c1030. No abstract available.
• Alam A, Gomes T, Zheng H, Mamdani MM, Juurlink DN, Bell CM. Long-term analgesic use after low-risk surgery: a retrospective cohort study. Arch Intern Med. 2012 Mar 12;172(5):425-30. doi: 10.1001/archinternmed.2011.1827.
• Hill MV, Stucke RS, McMahon ML, Beeman JL, Barth RJ Jr. An Educational Intervention Decreases Opioid Prescribing After General Surgical Operations. Ann Surg. 2018 Mar;267(3):468-472. doi: 10.1097/SLA.0000000000002198.
• Kose O, Saglam HS, Altun ME, Sonbahar T, Kumsar S, Adsan O. Prilocaine irrigation for pain relief after transurethral resection of the prostate. J Endourol. 2013 Jul;27(7):892-5. doi: 10.1089/end.2013.0001. Epub 2013 Jun 12.
• Maughan BC, Hersh EV, Shofer FS, Wanner KJ, Archer E, Carrasco LR, Rhodes KV. Unused opioid analgesics and drug disposal following outpatient dental surgery: A randomized controlled trial. Drug Alcohol Depend. 2016 Nov 1;168:328-334. doi: 10.1016/j.drugalcdep.2016.08.016. Epub 2016 Sep 20.

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2017
• Primary Completion (Anticipated): October 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: September 23, 2019
• First Submitted That Met QC Criteria: September 23, 2019
• First Posted (Actual): September 25, 2019

Study Record Updates

• Last Update Posted (Actual): September 27, 2019
• Last Update Submitted That Met QC Criteria: September 25, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: postoperative pain; Transurethral resection of the prostate; Multimodal pain control
• Additional Relevant MeSH Terms: Urological Manifestations; Lower Urinary Tract Symptoms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ibuprofen
• Other Study ID Numbers: IRB17-098

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared with other researchers. IPD will be used solely for this study cohort and protocol.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No