What is the Most Effective Local Anesthesia for Prostate-stained Ultrasonography-guided Biopsy in PPB and PNB?: A Single Center, Prospective, Randomized, Double Arm Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Gangnam Severance Hospital
- Enrollment
- 58
- Locations
- 2
- Primary Endpoint
- Visual analog scale-1
Study Overview
Brief Summary
This study assesses differences in the effects of pelvic plexus block and periprostatic nerve block among various anesthetic methods that reduce the pain caused by prostate biopsy.
Detailed Description
Recently, various types of local anesthetic methods have been attempted to reduce biopsy-related pain leading to changes in the type of anesthetic agents and site of injection. Of these anesthetics and combinations, pelvic plexus block and periprostatic nerve block seem to be the very effective way to control prostate biopsy-related pain. However, few studies have compared these two methods.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •abnormal prostate finding on digital rectal examination
- •serum PSA level of > 2.5 ng/mL
- •Transrectal ultrasonographic abnormal lesion
Exclusion Criteria
- •under 50 years old
- •a history of previous TRUS-guided biopsy
- •chronic prostatitis/pelvic pain
- •neurological conditions (dementia, Parkinson disease, or cerebral infarction)
- •bleeding diathesis
- •active UTI
- •hemorrhoids/anal fissure/anal fistula
- •known allergy to lidocaine
Outcomes
Primary Outcomes
Visual analog scale-1
Time Frame: day 7~14
Visual analog scale (0-10) during anesthesia procedure higher values represent a worse outcome.
Visual analog scale-4
Time Frame: day 7~14
Visual analog scale (0-10) at 15 min after the biopsy procedure higher values represent a worse outcome.
Visual analog scale-2
Time Frame: day 7~14
Visual analog scale (0-10) at insertion of ultrasound probe higher values represent a worse outcome.
Visual analog scale-3
Time Frame: day 7~14
Visual analog scale (0-10) during biopsy procedure higher values represent a worse outcome.
Secondary Outcomes
- Procedure time(day 7~14)
- Rate of Complication(day 14~28)
Investigators
Kang Su Cho
associate professor
Gangnam Severance Hospital