Recruiting

Pain ControlOptimizing Pain Control in Transurethral Resection of the Prostate

Sponsor:

Benaroya Research Institute

Code:

NCT04102566

Conditions

Pain

BPH With Urinary Obstruction

BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Accepted

Interventions

Ibuprofen 600 mg

Education

Study Details

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

Study ID

NCT04102566

Start date

Dec 8, 2017

Status verified date

Sep, 2019

Completion date

Dec 1, 2019

Anticipated

Primary completion date

Oct 1, 2019

Anticipated

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Interventions

Ibuprofen 600 mg

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

Education

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

Primary outcome measure

Opioid Consumption [ Time Frame: PACU-72 hours ]
Pain Scores [ Time Frame: PACU-72 hours ]

Central Contacts and Locations

Central contacts

Ryan Donahue, MD

2062236600 ryan.donahue@vmmc.org

Locations

Virginia Mason Medical Center

Recruiting

Seattle, Washington, United States, 98101

Contacts

Ryan Donahue, MD

512-484-3214 ryan.donahue@vmmc.org

Una Lee, MD

2062236749 una.lee@vmmc.org

Principal Investigator:

Una Lee, MD

More Information

Sponsor

Benaroya Research Institute

Last update posted

Sep 27, 2019

Last verified

Sep, 2019

Keywords

postoperative pain
Transurethral resection of the prostate
Multimodal pain control

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Benaroya Research Institute on 2019-09-27.