NCT04064047

Anorectal Application of 5% Lidocaine Cream Reduces Pain Prior to Periprostatic Nerve Block During Transrectal Ultrasound Guided Biopsy

Anorectal Application of 5% Lidocaine Cream Reduces Pain Prior to Periprostatic Nerve Block During Transrectal Ultrasound Guided Biopsy: Randomized, Prospective Controlled Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 284 (actual)
• Sponsor: Assaf-Harofeh Medical Center · Other Government
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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 manipulation prior to nerve blockage. Our study goal is to assess whether topical analgesia would reduce pain during the early stages of the procedure.

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: (1) nerve block with 5 ml 1% lidocaine for each neurovascular bundle + perianal topical application of 10 ml 5% lidocaine cream; (2) as in (1) plus application of 10 ml 5% lidocaine cream evenly on rectal walls. For each approach exposure times of 5, 10 and 20 minutes were allowed, all together 6 groups plus a control group of patients who received periprostatic nerve block only. A 0-10 Visual analogue scale (VAS) was filled by the patients at 5 time points: immediately after probe insertion, during probe manipulation and prostate assessment, immediately following neurovascular bundle nerve blockage, after prostate biopsies and a global pain estimation of the procedure.

Conditions

• Pain
• Prostate Cancer
• Rectal/Anal

Interventions

Type	Name	Description
PROCEDURE	Trans rectal ultrasound guided prostate biopsy	The investigators checked visual analogue scale of pain at different time periods: prior to probe insertion, during probe insertion. during probe manipulation in the rectum, during performance of periprostatic nerve block, during actual biopsy collection and at termination of procedure.
PROCEDURE	Trans rectal ultrasound	Performing a prostate biopsy using a transrectal ultrasound probe - the BK pro focus 2202 transrectal ultrasound and the 8808 bi-plane transrectal probe
PROCEDURE	Prostate biopsy	Prostate biopsy guided by a transrectal ultrasound with an 18 gauge needle
PROCEDURE	Periprostatic nerve block	Performing a bilateral peri-prostatic nerve block with 10 mL of 1% lidocaine (5 mL on each side)

Timeline

• Start date: 2016-12-01
• Primary completion: 2017-07-01
• Completion: 2017-07-01
• First posted: 2019-08-21
• Last updated: 2020-01-13