NCT Number: NCT04064047
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.
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Notify Me18 year and older
Male
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Performing a prostate biopsy using a transrectal ultrasound probe - the BK pro focus 2202 transrectal ultrasound and the 8808 bi-plane transrectal probe
Other names: BK pro focus 2202 transrectal ultrasound and the 8808 bi-plane transrectal probe
Prostate biopsy guided by a transrectal ultrasound with an 18 gauge needle
Performing a bilateral peri-prostatic nerve block with 10 mL of 1% lidocaine (5 mL on each side)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Assaf-Harofeh Medical Center
Other Gov
Anorectal Application of 5% Lidocaine Cream Reduces Pain Prior to Periprostatic Nerve Block During Transrectal Ultrasound Guided Biopsy: Randomized, Prospective Controlled Study
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