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

Not Applicable

Completed

• Conditions: Prostate Cancer; Rectal/Anal; Pain
• Interventions: Procedure: Trans rectal ultrasound guided prostate biopsy; Procedure: Trans rectal ultrasound; Procedure: Prostate biopsy; Procedure: Periprostatic nerve block

• Registration Number: NCT04064047
• Lead Sponsor: Assaf-Harofeh Medical Center

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 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.

Study Timeline

• Study Start: 2016-12
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Study First Submitted: 2019-01-20
• Study First Submitted QC: 2019-08-19
• Study First Posted: 2019-08-21
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-08
• Last Update Posted: 2020-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 284

Inclusion Criteria

• 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 Criteria

• Known sensitivity to Lidocaine
• Pre-planned biopsy under general anesthesia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
External Anal application - 20 minutes exposure	Periprostatic nerve block	Anal application of lidocaine cream 5% for 20 minutes before probe insertion. After probe insertion and prior to biopsy, a periprostatic nerve block was performed with 10 mL of 1% Lidocaine (5 mL on each side).
External Anal application - 10 minutes exposure	Trans rectal ultrasound	Anal application of lidocaine cream 5% for 10 minutes before probe insertion. After probe insertion and prior to biopsy, a periprostatic nerve block was performed with 10 mL of 1% Lidocaine (5 mL on each side).
External Anal application - 20 minutes exposure	Trans rectal ultrasound	Anal application of lidocaine cream 5% for 20 minutes before probe insertion. After probe insertion and prior to biopsy, a periprostatic nerve block was performed with 10 mL of 1% Lidocaine (5 mL on each side).
External Anal application - 5 minutes exposure	Prostate biopsy	Anal application of lidocaine cream 5% for 5 minutes before probe insertion. After probe insertion and prior to biopsy, a periprostatic nerve block was performed with 10 mL of 1% Lidocaine (5 mL on each side).
External Anal application - 5 minutes exposure	Periprostatic nerve block	Anal application of lidocaine cream 5% for 5 minutes before probe insertion. After probe insertion and prior to biopsy, a periprostatic nerve block was performed with 10 mL of 1% Lidocaine (5 mL on each side).
External Anal application - 10 minutes exposure	Periprostatic nerve block	Anal application of lidocaine cream 5% for 10 minutes before probe insertion. After probe insertion and prior to biopsy, a periprostatic nerve block was performed with 10 mL of 1% Lidocaine (5 mL on each side).
External Anal application - 10 minutes exposure	Trans rectal ultrasound guided prostate biopsy	Anal application of lidocaine cream 5% for 10 minutes before probe insertion. After probe insertion and prior to biopsy, a periprostatic nerve block was performed with 10 mL of 1% Lidocaine (5 mL on each side).
External Anal application - 10 minutes exposure	Prostate biopsy	Anal application of lidocaine cream 5% for 10 minutes before probe insertion. After probe insertion and prior to biopsy, a periprostatic nerve block was performed with 10 mL of 1% Lidocaine (5 mL on each side).
External Anal application - 20 minutes exposure	Trans rectal ultrasound guided prostate biopsy	Anal application of lidocaine cream 5% for 20 minutes before probe insertion. After probe insertion and prior to biopsy, a periprostatic nerve block was performed with 10 mL of 1% Lidocaine (5 mL on each side).
External Anal application - 20 minutes exposure	Prostate biopsy	Anal application of lidocaine cream 5% for 20 minutes before probe insertion. After probe insertion and prior to biopsy, a periprostatic nerve block was performed with 10 mL of 1% Lidocaine (5 mL on each side).
External Anal plus intrarectal - 10 minutes exposure	Trans rectal ultrasound guided prostate biopsy	Anal application plus intrarectal application of 5% lidocaine cream for 10 minutes before probe insertion. After probe insertion and prior to biopsy, a periprostatic nerve block was performed with 10 mL of 1% Lidocaine (5 mL on each side).
External Anal plus intrarectal - 10 minutes exposure	Periprostatic nerve block	Anal application plus intrarectal application of 5% lidocaine cream for 10 minutes before probe insertion. After probe insertion and prior to biopsy, a periprostatic nerve block was performed with 10 mL of 1% Lidocaine (5 mL on each side).
External Anal application - 5 minutes exposure	Trans rectal ultrasound guided prostate biopsy	Anal application of lidocaine cream 5% for 5 minutes before probe insertion. After probe insertion and prior to biopsy, a periprostatic nerve block was performed with 10 mL of 1% Lidocaine (5 mL on each side).
External Anal application - 5 minutes exposure	Trans rectal ultrasound	Anal application of lidocaine cream 5% for 5 minutes before probe insertion. After probe insertion and prior to biopsy, a periprostatic nerve block was performed with 10 mL of 1% Lidocaine (5 mL on each side).
External Anal plus intrarectal - 5 minutes exposure	Prostate biopsy	Anal application plus intrarectal application of 5% lidocaine cream for 5 minutes before probe insertion. After probe insertion and prior to biopsy, a periprostatic nerve block was performed with 10 mL of 1% Lidocaine (5 mL on each side).
External Anal plus intrarectal - 5 minutes exposure	Periprostatic nerve block	Anal application plus intrarectal application of 5% lidocaine cream for 5 minutes before probe insertion. After probe insertion and prior to biopsy, a periprostatic nerve block was performed with 10 mL of 1% Lidocaine (5 mL on each side).
External Anal plus intrarectal - 20 minutes exposure	Trans rectal ultrasound	Anal application plus intrarectal application of 5% lidocaine cream for 20 minutes before probe insertion. After probe insertion and prior to biopsy, a periprostatic nerve block was performed with 10 mL of 1% Lidocaine (5 mL on each side).
External Anal plus intrarectal - 5 minutes exposure	Trans rectal ultrasound guided prostate biopsy	Anal application plus intrarectal application of 5% lidocaine cream for 5 minutes before probe insertion. After probe insertion and prior to biopsy, a periprostatic nerve block was performed with 10 mL of 1% Lidocaine (5 mL on each side).
External Anal plus intrarectal - 10 minutes exposure	Trans rectal ultrasound	Anal application plus intrarectal application of 5% lidocaine cream for 10 minutes before probe insertion. After probe insertion and prior to biopsy, a periprostatic nerve block was performed with 10 mL of 1% Lidocaine (5 mL on each side).
External Anal plus intrarectal - 10 minutes exposure	Prostate biopsy	Anal application plus intrarectal application of 5% lidocaine cream for 10 minutes before probe insertion. After probe insertion and prior to biopsy, a periprostatic nerve block was performed with 10 mL of 1% Lidocaine (5 mL on each side).
Control group	Trans rectal ultrasound guided prostate biopsy	No anal application of lidocaine cream prior to probe insertion. After probe insertion and prior to biopsy, a periprostatic nerve block was performed with 10 mL of 1% Lidocaine (5 mL on each side).
Control group	Prostate biopsy	No anal application of lidocaine cream prior to probe insertion. After probe insertion and prior to biopsy, a periprostatic nerve block was performed with 10 mL of 1% Lidocaine (5 mL on each side).
Control group	Periprostatic nerve block	No anal application of lidocaine cream prior to probe insertion. After probe insertion and prior to biopsy, a periprostatic nerve block was performed with 10 mL of 1% Lidocaine (5 mL on each side).
External Anal plus intrarectal - 5 minutes exposure	Trans rectal ultrasound	Anal application plus intrarectal application of 5% lidocaine cream for 5 minutes before probe insertion. After probe insertion and prior to biopsy, a periprostatic nerve block was performed with 10 mL of 1% Lidocaine (5 mL on each side).
External Anal plus intrarectal - 20 minutes exposure	Prostate biopsy	Anal application plus intrarectal application of 5% lidocaine cream for 20 minutes before probe insertion. After probe insertion and prior to biopsy, a periprostatic nerve block was performed with 10 mL of 1% Lidocaine (5 mL on each side).
Control group	Trans rectal ultrasound	No anal application of lidocaine cream prior to probe insertion. After probe insertion and prior to biopsy, a periprostatic nerve block was performed with 10 mL of 1% Lidocaine (5 mL on each side).
External Anal plus intrarectal - 20 minutes exposure	Trans rectal ultrasound guided prostate biopsy	Anal application plus intrarectal application of 5% lidocaine cream for 20 minutes before probe insertion. After probe insertion and prior to biopsy, a periprostatic nerve block was performed with 10 mL of 1% Lidocaine (5 mL on each side).
External Anal plus intrarectal - 20 minutes exposure	Periprostatic nerve block	Anal application plus intrarectal application of 5% lidocaine cream for 20 minutes before probe insertion. After probe insertion and prior to biopsy, a periprostatic nerve block was performed with 10 mL of 1% Lidocaine (5 mL on each side).

Primary Outcome Measures

Name	Time	Method
Pain level during TRUS probe manipulation in the rectum	During transrectal ultrasound probe manipulation in the rectum (estimated at 0-2 minutes length)	Self reported by the patient using a 0-10 visual analogue scale. 0 being no pain at all, 10 being worst pain imaginable.
Pain level at TRUS probe insertion	During transrectal ultrasound probe insertion into the rectum (defined as beginning of procedure)	Self reported by the patient using a 0-10 visual analogue scale. 0 being no pain at all, 10 being worst pain imaginable.
Pain level before probe insertion	Before transrectal ultrasound probe insertion	Self reported by the patient using a 0-10 visual analogue scale. 0 being no pain at all, 10 being worst pain imaginable.
Pain level during periprostatic nerve block	During periprostatic nerve block (rectal wall puncture with needle, estimated at 2-3 minutes after beginning of procedure)	Self reported by the patient using a 0-10 visual analogue scale. 0 being no pain at all, 10 being worst pain imaginable.
Pain level during biopsy collection	During biopsy collection using an 18-gauge needle (estimated at 3-10 minutes from beginning of procedure)	Self reported by the patient using a 0-10 visual analogue scale. 0 being no pain at all, 10 being worst pain imaginable.
Pain level at termination of procedure	At termination of procedure (total estimated length of procedure is 10 minutes).	Self reported by the patient using a 0-10 visual analogue scale. 0 being no pain at all, 10 being worst pain imaginable.