NCT04064047

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
284

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable pain

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 20, 2019

Completed
7 months until next milestone

First Posted

Study publicly available on registry

August 21, 2019

Completed
Last Updated

January 13, 2020

Status Verified

January 1, 2020

Enrollment Period

7 months

First QC Date

January 20, 2019

Last Update Submit

January 8, 2020

Conditions

PainProstate CancerRectal/Anal

Outcome Measures

Primary Outcomes (6)

  • 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).

Study Arms (7)

External Anal application - 5 minutes exposure

ACTIVE COMPARATOR

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 biopsyProcedure: Trans rectal ultrasoundProcedure: Prostate biopsyProcedure: Periprostatic nerve block

External Anal application - 10 minutes exposure

ACTIVE COMPARATOR

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 biopsyProcedure: Trans rectal ultrasoundProcedure: Prostate biopsyProcedure: Periprostatic nerve block

External Anal application - 20 minutes exposure

ACTIVE COMPARATOR

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 biopsyProcedure: Trans rectal ultrasoundProcedure: Prostate biopsyProcedure: Periprostatic nerve block

External Anal plus intrarectal - 5 minutes exposure

ACTIVE COMPARATOR

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 biopsyProcedure: Trans rectal ultrasoundProcedure: Prostate biopsyProcedure: Periprostatic nerve block

External Anal plus intrarectal - 10 minutes exposure

ACTIVE COMPARATOR

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 biopsyProcedure: Trans rectal ultrasoundProcedure: Prostate biopsyProcedure: Periprostatic nerve block

External Anal plus intrarectal - 20 minutes exposure

ACTIVE COMPARATOR

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 biopsyProcedure: Trans rectal ultrasoundProcedure: Prostate biopsyProcedure: Periprostatic nerve block

Control group

SHAM COMPARATOR

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 biopsyProcedure: Trans rectal ultrasoundProcedure: Prostate biopsyProcedure: Periprostatic nerve block

Interventions

Trans rectal ultrasound guided prostate biopsyPROCEDURE

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.

Control groupExternal Anal application - 10 minutes exposureExternal Anal application - 20 minutes exposureExternal Anal application - 5 minutes exposureExternal Anal plus intrarectal - 10 minutes exposureExternal Anal plus intrarectal - 20 minutes exposureExternal Anal plus intrarectal - 5 minutes exposure
Trans rectal ultrasoundPROCEDURE

Performing a prostate biopsy using a transrectal ultrasound probe - the BK pro focus 2202 transrectal ultrasound and the 8808 bi-plane transrectal probe

Also known as: BK pro focus 2202 transrectal ultrasound and the 8808 bi-plane transrectal probe
Control groupExternal Anal application - 10 minutes exposureExternal Anal application - 20 minutes exposureExternal Anal application - 5 minutes exposureExternal Anal plus intrarectal - 10 minutes exposureExternal Anal plus intrarectal - 20 minutes exposureExternal Anal plus intrarectal - 5 minutes exposure
Prostate biopsyPROCEDURE

Prostate biopsy guided by a transrectal ultrasound with an 18 gauge needle

Control groupExternal Anal application - 10 minutes exposureExternal Anal application - 20 minutes exposureExternal Anal application - 5 minutes exposureExternal Anal plus intrarectal - 10 minutes exposureExternal Anal plus intrarectal - 20 minutes exposureExternal Anal plus intrarectal - 5 minutes exposure
Periprostatic nerve blockPROCEDURE

Performing a bilateral peri-prostatic nerve block with 10 mL of 1% lidocaine (5 mL on each side)

Control groupExternal Anal application - 10 minutes exposureExternal Anal application - 20 minutes exposureExternal Anal application - 5 minutes exposureExternal Anal plus intrarectal - 10 minutes exposureExternal Anal plus intrarectal - 20 minutes exposureExternal Anal plus intrarectal - 5 minutes exposure

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsOnly those patients requiring a prostate biopsy
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Lee C, Woo HH. Current methods of analgesia for transrectal ultrasonography (TRUS)-guided prostate biopsy -- a systematic review. BJU Int. 2014 Mar;113 Suppl 2:48-56. doi: 10.1111/bju.12433.

    PMID: 24053451RESULT

  • Tiong HY, Liew LC, Samuel M, Consigliere D, Esuvaranathan K. A meta-analysis of local anesthesia for transrectal ultrasound-guided biopsy of the prostate. Prostate Cancer Prostatic Dis. 2007;10(2):127-36. doi: 10.1038/sj.pcan.4500935. Epub 2007 Jan 9.

    PMID: 17211441RESULT

  • Wang J, Wang L, Du Y, He D, Chen X, Li L, Nan X, Fan J. Addition of intrarectal local analgesia to periprostatic nerve block improves pain control for transrectal ultrasonography-guided prostate biopsy: a systematic review and meta-analysis. Int J Urol. 2015 Jan;22(1):62-8. doi: 10.1111/iju.12595. Epub 2014 Aug 21.

    PMID: 25141759RESULT

  • Raber M, Scattoni V, Roscigno M, Deho F, Briganti A, Salonia A, Gallina A, Di Girolamo V, Montorsi F, Rigatti P. Topical prilocaine-lidocaine cream combined with peripheral nerve block improves pain control in prostatic biopsy: results from a prospective randomized trial. Eur Urol. 2008 May;53(5):967-73. doi: 10.1016/j.eururo.2007.09.005. Epub 2007 Sep 18.

    PMID: 17904278RESULT

  • Giannarini G, Autorino R, Valent F, Mogorovich A, Manassero F, De Maria M, Morelli G, Barbone F, Di Lorenzo G, Selli C. Combination of perianal-intrarectal lidocaine-prilocaine cream and periprostatic nerve block for pain control during transrectal ultrasound guided prostate biopsy: a randomized, controlled trial. J Urol. 2009 Feb;181(2):585-91; discussion 591-3. doi: 10.1016/j.juro.2008.10.002. Epub 2008 Dec 13.

    PMID: 19084860RESULT

  • Barcohana N, Duperon DF, Yashar M. The relationship of application time to EMLA efficacy. J Dent Child (Chic). 2003 Jan-Apr;70(1):51-4.

    PMID: 12762609RESULT

MeSH Terms

Conditions

PainProstatic Neoplasms

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsGenital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Judith Ben Zvi

    Assaf Harofeh Medical Center ethical committee for experiments in humans

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2019

First Posted

August 21, 2019

Study Start

December 1, 2016

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

January 13, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share