Anorectal Application of 5% Lidocaine Cream Reduces Pain Prior to Periprostatic Nerve Block During Transrectal Ultrasound Guided Biopsy
NCT ID: NCT04064047
Last Updated: 2020-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
284 participants
INTERVENTIONAL
2016-12-31
2017-07-31
Brief Summary
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Our study goal is to assess whether topical analgesia would reduce pain during the early stages of the procedure.
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Detailed Description
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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
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Study Design
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RANDOMIZED
FACTORIAL
SUPPORTIVE_CARE
SINGLE
Study Groups
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External Anal application - 5 minutes exposure
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).
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.
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
Prostate biopsy
Prostate biopsy guided by a transrectal ultrasound with an 18 gauge needle
Periprostatic nerve block
Performing a bilateral peri-prostatic nerve block with 10 mL of 1% lidocaine (5 mL on each side)
External Anal application - 10 minutes exposure
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).
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.
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
Prostate biopsy
Prostate biopsy guided by a transrectal ultrasound with an 18 gauge needle
Periprostatic nerve block
Performing a bilateral peri-prostatic nerve block with 10 mL of 1% lidocaine (5 mL on each side)
External Anal application - 20 minutes exposure
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).
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.
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
Prostate biopsy
Prostate biopsy guided by a transrectal ultrasound with an 18 gauge needle
Periprostatic nerve block
Performing a bilateral peri-prostatic nerve block with 10 mL of 1% lidocaine (5 mL on each side)
External Anal plus intrarectal - 5 minutes exposure
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).
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.
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
Prostate biopsy
Prostate biopsy guided by a transrectal ultrasound with an 18 gauge needle
Periprostatic nerve block
Performing a bilateral peri-prostatic nerve block with 10 mL of 1% lidocaine (5 mL on each side)
External Anal plus intrarectal - 10 minutes exposure
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).
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.
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
Prostate biopsy
Prostate biopsy guided by a transrectal ultrasound with an 18 gauge needle
Periprostatic nerve block
Performing a bilateral peri-prostatic nerve block with 10 mL of 1% lidocaine (5 mL on each side)
External Anal plus intrarectal - 20 minutes exposure
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).
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.
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
Prostate biopsy
Prostate biopsy guided by a transrectal ultrasound with an 18 gauge needle
Periprostatic nerve block
Performing a bilateral peri-prostatic nerve block with 10 mL of 1% lidocaine (5 mL on each side)
Control group
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).
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.
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
Prostate biopsy
Prostate biopsy guided by a transrectal ultrasound with an 18 gauge needle
Periprostatic nerve block
Performing a bilateral peri-prostatic nerve block with 10 mL of 1% lidocaine (5 mL on each side)
Interventions
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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.
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
Prostate biopsy
Prostate biopsy guided by a transrectal ultrasound with an 18 gauge needle
Periprostatic nerve block
Performing a bilateral peri-prostatic nerve block with 10 mL of 1% lidocaine (5 mL on each side)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Pre-planned biopsy under general anesthesia
18 Years
MALE
No
Sponsors
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Assaf-Harofeh Medical Center
OTHER_GOV
Responsible Party
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Principal Investigators
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Judith Ben Zvi
Role: STUDY_CHAIR
Assaf Harofeh Medical Center ethical committee for experiments in humans
References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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Assaf-HarofehMC 0289-15-ASF
Identifier Type: -
Identifier Source: org_study_id
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