Status:
COMPLETED
Anorectal Application of 5% Lidocaine Cream Reduces Pain Prior to Periprostatic Nerve Block During Transrectal Ultrasound Guided Biopsy
Lead Sponsor:
Assaf-Harofeh Medical Center
Conditions:
Pain
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
Transrectal ultrasound guided prostate biopsy is performed with a periprostatic nerve block to the neurovascular bundle bilaterally. This does not reduce the pain due to probe insertion and manipulati...
Detailed Description
Prospective, randomized controlled study. Patients signed an informed consent form. Exclusion criteria were Lidocaine allergy or pre-planned general anesthesia. Patients were randomized into 6 groups...
Eligibility Criteria
Inclusion
- Males referred to TRUSGBx due to elevated prostate specific antigen (PSA)
- Abnormal findings on digital rectal examination (DRE)
- Repeat biopsies as part of Active Surveillance (AS)
- Continuously elevated PSA levels despite prior negative for malignancy biopsies
- Previous histological findings of significant HGPIN were enrolled
Exclusion
- Known sensitivity to Lidocaine
- Pre-planned biopsy under general anesthesia
Key Trial Info
Start Date :
December 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2017
Estimated Enrollment :
284 Patients enrolled
Trial Details
Trial ID
NCT04064047
Start Date
December 1 2016
End Date
July 1 2017
Last Update
January 13 2020
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