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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pain, Prostate Cancer, Rectal/Anal

Intervention / Treatment
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* Procedure: Trans rectal ultrasound guided prostate biopsy
* Procedure: Trans rectal ultrasound
* Procedure: Prostate biopsy
* Procedure: Periprostatic nerve block


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: External Anal application - 5 minutes exposure<br>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). | Procedure: Trans rectal ultrasound guided prostate biopsy<br>* 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.<br>Procedure: Trans rectal ultrasound<br>* Performing a prostate biopsy using a transrectal ultrasound probe - the BK pro focus 2202 transrectal ultrasound and the 8808 bi-plane transrectal probe<br>* Other names: BK pro focus 2202 transrectal ultrasound and the 8808 bi-plane transrectal probe;Procedure: Prostate biopsy<br>* Prostate biopsy guided by a transrectal ultrasound with an 18 gauge needle<br>Procedure: Periprostatic nerve block<br>* Performing a bilateral peri-prostatic nerve block with 10 mL of 1% lidocaine (5 mL on each side)<br>|
| Active Comparator: External Anal application - 10 minutes exposure<br>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). | Procedure: Trans rectal ultrasound guided prostate biopsy<br>* 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.<br>Procedure: Trans rectal ultrasound<br>* Performing a prostate biopsy using a transrectal ultrasound probe - the BK pro focus 2202 transrectal ultrasound and the 8808 bi-plane transrectal probe<br>* Other names: BK pro focus 2202 transrectal ultrasound and the 8808 bi-plane transrectal probe;Procedure: Prostate biopsy<br>* Prostate biopsy guided by a transrectal ultrasound with an 18 gauge needle<br>Procedure: Periprostatic nerve block<br>* Performing a bilateral peri-prostatic nerve block with 10 mL of 1% lidocaine (5 mL on each side)<br>|
| Active Comparator: External Anal application - 20 minutes exposure<br>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). | Procedure: Trans rectal ultrasound guided prostate biopsy<br>* 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.<br>Procedure: Trans rectal ultrasound<br>* Performing a prostate biopsy using a transrectal ultrasound probe - the BK pro focus 2202 transrectal ultrasound and the 8808 bi-plane transrectal probe<br>* Other names: BK pro focus 2202 transrectal ultrasound and the 8808 bi-plane transrectal probe;Procedure: Prostate biopsy<br>* Prostate biopsy guided by a transrectal ultrasound with an 18 gauge needle<br>Procedure: Periprostatic nerve block<br>* Performing a bilateral peri-prostatic nerve block with 10 mL of 1% lidocaine (5 mL on each side)<br>|
| Active Comparator: External Anal plus intrarectal - 5 minutes exposure<br>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). | Procedure: Trans rectal ultrasound guided prostate biopsy<br>* 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.<br>Procedure: Trans rectal ultrasound<br>* Performing a prostate biopsy using a transrectal ultrasound probe - the BK pro focus 2202 transrectal ultrasound and the 8808 bi-plane transrectal probe<br>* Other names: BK pro focus 2202 transrectal ultrasound and the 8808 bi-plane transrectal probe;Procedure: Prostate biopsy<br>* Prostate biopsy guided by a transrectal ultrasound with an 18 gauge needle<br>Procedure: Periprostatic nerve block<br>* Performing a bilateral peri-prostatic nerve block with 10 mL of 1% lidocaine (5 mL on each side)<br>|
| Active Comparator: External Anal plus intrarectal - 10 minutes exposure<br>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). | Procedure: Trans rectal ultrasound guided prostate biopsy<br>* 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.<br>Procedure: Trans rectal ultrasound<br>* Performing a prostate biopsy using a transrectal ultrasound probe - the BK pro focus 2202 transrectal ultrasound and the 8808 bi-plane transrectal probe<br>* Other names: BK pro focus 2202 transrectal ultrasound and the 8808 bi-plane transrectal probe;Procedure: Prostate biopsy<br>* Prostate biopsy guided by a transrectal ultrasound with an 18 gauge needle<br>Procedure: Periprostatic nerve block<br>* Performing a bilateral peri-prostatic nerve block with 10 mL of 1% lidocaine (5 mL on each side)<br>|
| Active Comparator: External Anal plus intrarectal - 20 minutes exposure<br>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). | Procedure: Trans rectal ultrasound guided prostate biopsy<br>* 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.<br>Procedure: Trans rectal ultrasound<br>* Performing a prostate biopsy using a transrectal ultrasound probe - the BK pro focus 2202 transrectal ultrasound and the 8808 bi-plane transrectal probe<br>* Other names: BK pro focus 2202 transrectal ultrasound and the 8808 bi-plane transrectal probe;Procedure: Prostate biopsy<br>* Prostate biopsy guided by a transrectal ultrasound with an 18 gauge needle<br>Procedure: Periprostatic nerve block<br>* Performing a bilateral peri-prostatic nerve block with 10 mL of 1% lidocaine (5 mL on each side)<br>|
| Sham Comparator: Control group<br>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). | Procedure: Trans rectal ultrasound guided prostate biopsy<br>* 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.<br>Procedure: Trans rectal ultrasound<br>* Performing a prostate biopsy using a transrectal ultrasound probe - the BK pro focus 2202 transrectal ultrasound and the 8808 bi-plane transrectal probe<br>* Other names: BK pro focus 2202 transrectal ultrasound and the 8808 bi-plane transrectal probe;Procedure: Prostate biopsy<br>* Prostate biopsy guided by a transrectal ultrasound with an 18 gauge needle<br>Procedure: Periprostatic nerve block<br>* Performing a bilateral peri-prostatic nerve block with 10 mL of 1% lidocaine (5 mL on each side)<br>|

What is the study measuring?
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Primary Outcome Measures

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