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

Primary Purpose

Pain, Prostate Cancer, Rectal/Anal

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Trans rectal ultrasound guided prostate biopsy

Trans rectal ultrasound

Prostate biopsy

Periprostatic nerve block

About this trial

This is an interventional supportive care trial for Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Active Comparator

Sham Comparator

Arm Label

External Anal application - 5 minutes exposure

External Anal application - 10 minutes exposure

External Anal application - 20 minutes exposure

External Anal plus intrarectal - 5 minutes exposure

External Anal plus intrarectal - 10 minutes exposure

External Anal plus intrarectal - 20 minutes exposure

Control group

Arm Description

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).

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).

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).

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).

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).

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).

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).

Outcomes

Primary Outcome Measures

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.

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.

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.

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.

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04064047

First Posted

January 20, 2019

Last Updated

January 8, 2020

Sponsor

Assaf-Harofeh Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT04064047

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Completed

Study Start Date

December 2016 (Actual)

Primary Completion Date

July 2017 (Actual)

Study Completion Date

July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assaf-Harofeh Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Prostate Cancer, Rectal/Anal

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

Participant

Allocation

Randomized

Enrollment

284 (Actual)

8. Arms, Groups, and Interventions

Arm Title

External Anal application - 5 minutes exposure

Arm Type

Active Comparator

Arm Description

Arm Title

External Anal application - 10 minutes exposure

Arm Type

Active Comparator

Arm Description

Arm Title

External Anal application - 20 minutes exposure

Arm Type

Active Comparator

Arm Description

Arm Title

External Anal plus intrarectal - 5 minutes exposure

Arm Type

Active Comparator

Arm Description

Arm Title

External Anal plus intrarectal - 10 minutes exposure

Arm Type

Active Comparator

Arm Description

Arm Title

External Anal plus intrarectal - 20 minutes exposure

Arm Type

Active Comparator

Arm Description

Arm Title

Control group

Arm Type

Sham Comparator

Arm Description

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).

Intervention Type

Procedure

Intervention Name(s)

Trans rectal ultrasound guided prostate biopsy

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Trans rectal ultrasound

Other Intervention Name(s)

BK pro focus 2202 transrectal ultrasound and the 8808 bi-plane transrectal probe

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Prostate biopsy

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Periprostatic nerve block

Intervention Description

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

Primary Outcome Measure Information:

Title

Pain level before probe insertion

Description

Self reported by the patient using a 0-10 visual analogue scale. 0 being no pain at all, 10 being worst pain imaginable.

Time Frame

Before transrectal ultrasound probe insertion

Title

Pain level at TRUS probe insertion

Description

Self reported by the patient using a 0-10 visual analogue scale. 0 being no pain at all, 10 being worst pain imaginable.

Time Frame

During transrectal ultrasound probe insertion into the rectum (defined as beginning of procedure)

Title

Pain level during TRUS probe manipulation in the rectum

Description

Self reported by the patient using a 0-10 visual analogue scale. 0 being no pain at all, 10 being worst pain imaginable.

Time Frame

During transrectal ultrasound probe manipulation in the rectum (estimated at 0-2 minutes length)

Title

Pain level during periprostatic nerve block

Description

Self reported by the patient using a 0-10 visual analogue scale. 0 being no pain at all, 10 being worst pain imaginable.

Time Frame

During periprostatic nerve block (rectal wall puncture with needle, estimated at 2-3 minutes after beginning of procedure)

Title

Pain level during biopsy collection

Description

Self reported by the patient using a 0-10 visual analogue scale. 0 being no pain at all, 10 being worst pain imaginable.

Time Frame

During biopsy collection using an 18-gauge needle (estimated at 3-10 minutes from beginning of procedure)

Title

Pain level at termination of procedure

Description

Self reported by the patient using a 0-10 visual analogue scale. 0 being no pain at all, 10 being worst pain imaginable.

Time Frame

At termination of procedure (total estimated length of procedure is 10 minutes).

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

Only those patients requiring a prostate biopsy

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Judith Ben Zvi

Organizational Affiliation

Assaf Harofeh Medical Center ethical committee for experiments in humans

Official's Role

Study Chair

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

24053451

Citation

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.

Results Reference

result

PubMed Identifier

17211441

Citation

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.

Results Reference

result

PubMed Identifier

25141759

Citation

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.

Results Reference

result

PubMed Identifier

17904278

Citation

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.

Results Reference

result

PubMed Identifier

19084860

Citation

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.

Results Reference

result

PubMed Identifier

12762609

Citation

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.

Results Reference

result

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

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