Optimizing Pain Control in Transurethral Resection of the Prostate

NCT04102566 | Recruiting Phase 4 FDA Drug

• 1 other identifier: IRB17-098
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Presence of a foley catheter at discharge.

  0-48hours

• Presence of narcotic side effects

  48 hours after discharge

• Were there any post-operative complications

  0-48 hours

Study Arms (2)

Standard of care arm

NO INTERVENTION

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

Multi-modal group

EXPERIMENTAL

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

Interventions

Ibuprofen 600 mg DRUG

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

Multi-modal group

Education BEHAVIORAL

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

Multi-modal group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are identified as candidates for TURP
• Are 18 years of age or greater
• Are proficient in English

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Mason Hospital/Medical Center: collaborator
• Benaroya Research Institute: lead

Study Sites (1)

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

RECRUITING

Related Publications (8)

• 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.

  PMID: 22412106 BACKGROUND

• 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.

  PMID: 27400458 BACKGROUND

• 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.

  PMID: 28267689 BACKGROUND

• 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.

  PMID: 27631771 BACKGROUND

• 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.

  PMID: 23565930 BACKGROUND

• 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.

  PMID: 22227789 BACKGROUND

• 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.

  PMID: 26977696 BACKGROUND

• 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.

  PMID: 27663358 BACKGROUND

MeSH Terms

Conditions

Pain; Pain, Postoperative

Interventions

Ibuprofen; Educational Status

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Socioeconomic Factors; Population Characteristics

Central Study Contacts

Ryan Donahue, MD

CONTACT

2062236600; ryan.donahue@vmmc.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator and Attending urologist

Study Record Dates

• First Submitted: September 23, 2019
• First Posted: September 25, 2019
• Study Start: December 8, 2017
• Primary Completion: October 1, 2019
• Study Completion: December 1, 2019
• Last Updated: September 27, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)