Trials / Recruiting
RecruitingNCT04102566
Optimizing Pain Control in Transurethral Resection of the Prostate
- Status
- Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- Benaroya Research Institute · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
- Pain
- BPH With Urinary Obstruction
- BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2017-12-08
- Primary completion
- 2019-10-01
- Completion
- 2019-12-01
- First posted
- 2019-09-25
- Last updated
- 2019-09-27
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04102566. Inclusion in this directory is not an endorsement.