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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04064047

Enrollment

284

Registered

2019-08-21

Start date

2016-12-31

Completion date

2017-07-31

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Prostate Cancer, Rectal/Anal

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.

Interventions

PROCEDURETrans 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.

PROCEDURETrans 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

PROCEDUREProstate biopsy

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

PROCEDUREPeriprostatic nerve block

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

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Pain level before probe insertion	Before transrectal ultrasound 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	During transrectal ultrasound probe insertion into the rectum (defined as beginning 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.
Pain level during TRUS probe manipulation in the rectum	During transrectal ultrasound probe manipulation in the rectum (estimated at 0-2 minutes length)	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	During periprostatic nerve block (rectal wall puncture with needle, estimated at 2-3 minutes after beginning 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.
Pain level during biopsy collection	During biopsy collection using an 18-gauge needle (estimated at 3-10 minutes from beginning 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.
Pain level at termination of procedure	At termination of procedure (total estimated length of procedure is 10 minutes).	Self reported by the patient using a 0-10 visual analogue scale. 0 being no pain at all, 10 being worst pain imaginable.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026