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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04064047
• Other study ID #: Assaf-HarofehMC 0289-15-ASF
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: July 2017

Study information

• Verified date: January 2020
• Source: Assaf-Harofeh Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 284
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain
• Prostate Cancer
• Prostatic Neoplasms
• Rectal/Anal

Intervention

Procedure:
• 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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center

References & Publications (6)

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. — View 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 ultras — View 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. Review. — View Citation

Raber M, Scattoni V, Roscigno M, Dehò 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 — View 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. Epub 2007 Jan 9. Review. — View 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. 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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).