A Randomized Controlled Trial of Modifications to Prostate Needle-Based Procedures
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Enrollment
- 800
- Locations
- 8
- Primary Endpoint
- Change in the proportion of patients experiencing significant pain
Study Overview
Brief Summary
The purpose of this study is to look whether using local anesthesia during a transperineal prostate biopsy, while put to sleep by IV sedation, helps reduce the number of people who feel significant pain in the recovery room. The researchers will also look at how local anesthesia affects the amount of pain medication used, how quickly people can go home after the biopsy, and how well they recover after leaving the hospital.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Local anesthesia versus no local anesthesia during transperineal biopsy, while the patient is under IV sedation:
- •Patients scheduled for transperineal prostate biopsy at the JRSC or Monmouth.
- •Standardization of a periprocedural pathway versus usual care for focal gland ablation:
- •Patients scheduled for a partial prostate gland ablation procedure at the JRSC.
Exclusion Criteria
- •Local anesthesia versus no local anesthesia during transperineal biopsy, while patient is under IV sedation:
- •Standardization of a periprocedural pathway versus usual care for focal gland ablation:
Arms & Interventions
No Local anesthesia
No local anesthesia during transperineal biopsy under IV sedation
Intervention: Prostate Biopsy (Procedure)
Local anesthesia
Local anesthesia during transperineal biopsy under IV sedation
Intervention: Prostate Biopsy (Procedure)
Local anesthesia
Local anesthesia during transperineal biopsy under IV sedation
Intervention: Local anesthesia (Drug)
Outcomes
Primary Outcomes
Change in the proportion of patients experiencing significant pain
Time Frame: up to 1 day
defined as at least one pain score ≥ 5 on a 0 - 10 scale in the post anesthesia care unit (PACU)
Secondary Outcomes
No secondary outcomes reported