Clinical trial NCT04064047: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Prostate Cancer
Rectal/Anal
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2019-08-21
Enrollment: 284
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Pain level before probe insertion
timeFrame: Before transrectal ultrasound probe insertion
measure: Pain level at TRUS probe insertion
timeFrame: During transrectal ultrasound probe insertion into the rectum (defined as beginning of procedure)
measure: Pain level during TRUS probe manipulation in the rectum
timeFrame: During transrectal ultrasound probe manipulation in the rectum (estimated at 0-2 minutes length)
measure: Pain level during periprostatic nerve block
timeFrame: During periprostatic nerve block (rectal wall puncture with needle, estimated at 2-3 minutes after beginning of procedure)
measure: Pain level during biopsy collection
timeFrame: During biopsy collection using an 18-gauge needle (estimated at 3-10 minutes from beginning of procedure)
measure: Pain level at termination of procedure
timeFrame: At termination of procedure (total estimated length of procedure is 10 minutes).
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assaf Harofeh Medical Center ethical committee for experiments in humans
name: Judith Ben Zvi
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.
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