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Optimizing Pain Control in Transurethral Resection of the Prostate

Primary Purpose

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

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ibuprofen 600 mg
Education
Sponsored by
Benaroya Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring postoperative pain, Transurethral resection of the prostate, Multimodal pain control

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Virginia Mason Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard of care arm

Multi-modal group

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 23, 2019
Last Updated
September 25, 2019
Sponsor
Benaroya Research Institute
Collaborators
Virginia Mason Hospital/Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04102566
Brief Title
Optimizing Pain Control in Transurethral Resection of the Prostate
Official Title
Optimizing Pain Control in Transurethral Resection of the Prostate
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Recruiting
Study Start Date
December 8, 2017 (Actual)
Primary Completion Date
October 1, 2019 (Anticipated)
Study Completion Date
December 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benaroya Research Institute
Collaborators
Virginia Mason Hospital/Medical Center

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard of care arm
Arm Type
No Intervention
Arm Description
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
Arm Title
Multi-modal group
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Ibuprofen 600 mg
Intervention Description
We'll be adding ibuprofen while trying to limit oxycodone use while hospitalized. Patients will not be discharged with a narcotic.
Intervention Type
Behavioral
Intervention Name(s)
Education
Intervention Description
We'll be adding education to patient's post-operative instructions to aid in their pain control management.
Primary Outcome Measure Information:
Title
Opioid Consumption
Description
Total opioid utilization
Time Frame
PACU-72 hours
Title
Pain Scores
Description
Numerical Rating Scale Pain Scores (Range: 0-10, where 0 is no pain and 10 is the worst pain)
Time Frame
PACU-72 hours
Secondary Outcome Measure Information:
Title
Presence of a foley catheter at discharge.
Description
Was the patient discharged with a Foley catheter?
Time Frame
0-48hours
Title
Presence of narcotic side effects
Description
nausea/vomiting, pruritus, constipation, dizziness or feelings of sedation
Time Frame
48 hours after discharge
Title
Were there any post-operative complications
Description
Any complications post-operatively that occurred in the immediate post-operative setting.
Time Frame
0-48 hours

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ryan Donahue, MD
Phone
2062236600
Email
ryan.donahue@vmmc.org
Facility Information:
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryan Donahue, MD
Phone
512-484-3214
Email
ryan.donahue@vmmc.org
First Name & Middle Initial & Last Name & Degree
Una Lee, MD
Phone
2062236749
Email
una.lee@vmmc.org
First Name & Middle Initial & Last Name & Degree
Kathleen Kobashi, MD
First Name & Middle Initial & Last Name & Degree
Alvaro Lucioni, MD
First Name & Middle Initial & Last Name & Degree
Fred Govier, MD
First Name & Middle Initial & Last Name & Degree
Christopher Porter, MD
First Name & Middle Initial & Last Name & Degree
John Corman, MD
First Name & Middle Initial & Last Name & Degree
Thomas Pritchett, MD
First Name & Middle Initial & Last Name & Degree
Christopher Kuhr, MD
First Name & Middle Initial & Last Name & Degree
Dena Moskowitz, MD
First Name & Middle Initial & Last Name & Degree
Neil Hanson, MD
First Name & Middle Initial & Last Name & Degree
Andrew Stamm, MD
First Name & Middle Initial & Last Name & Degree
Ryan Donahue, MD
First Name & Middle Initial & Last Name & Degree
Una Lee, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD will not be shared with other researchers. IPD will be used solely for this study cohort and protocol.
Citations:
PubMed Identifier
22412106
Citation
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.
Results Reference
background
PubMed Identifier
27400458
Citation
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.
Results Reference
background
PubMed Identifier
28267689
Citation
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.
Results Reference
background
PubMed Identifier
27631771
Citation
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.
Results Reference
background
PubMed Identifier
23565930
Citation
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.
Results Reference
background
PubMed Identifier
22227789
Citation
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.
Results Reference
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PubMed Identifier
26977696
Citation
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.
Results Reference
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PubMed Identifier
27663358
Citation
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.
Results Reference
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Optimizing Pain Control in Transurethral Resection of the Prostate

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