Clinical trial · Interventional

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

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

NCT04064047CI-TRIAL-00042711completedN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (3)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Pain	—	UNRESOLVED	—
Prostate Cancer	Malignant Prostate Neoplasm	CURATED_EXACT	0.92
Rectal/Anal	—	UNRESOLVED	—

Interventions

Interventions (4)

Intervention	Type	Mapped drug	Match
Periprostatic nerve block	Procedure	—	UNRESOLVED
Prostate biopsy	Procedure	—	UNRESOLVED
Trans rectal ultrasound	Procedure	—	UNRESOLVED
Trans rectal ultrasound guided prostate biopsy	Procedure	—	UNRESOLVED

Design

Arms and outcomes

Arms (7)

type
ACTIVE_COMPARATOR
label
External Anal application - 5 minutes exposure
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).
interventionNames
1. Procedure: Trans rectal ultrasound guided prostate biopsy
2. Procedure: Trans rectal ultrasound
3. Procedure: Prostate biopsy
4. Procedure: Periprostatic nerve block
type
ACTIVE_COMPARATOR
label
External Anal application - 10 minutes exposure
description
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).
interventionNames
1. Procedure: Trans rectal ultrasound guided prostate biopsy
2. Procedure: Trans rectal ultrasound

Eligibility

Eligibility (as posted)

Sex: Male
Minimum age: 18 Years

Show eligibility criteria text

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

References

Publications (6)

RESULTLee 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 24053451
RESULTTiong 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 17211441
RESULTWang 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 25141759
RESULTRaber 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 17904278
RESULTGiannarini 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 19084860
RESULTBarcohana 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 12762609