An interventional study of Trans rectal ultrasound guided prostate biopsy and Trans rectal ultrasound in Pain, Prostate Cancer and Rectal/Anal, sponsored by Assaf-Harofeh Medical Center. Completed. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-13.
Sponsored by Assaf-Harofeh Medical Center · Not applicable, Interventional, and Supportive care
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.
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.
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Exclusion Criteria:
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).
Procedure: Trans rectal ultrasound guided prostate biopsy · Procedure: Trans rectal ultrasound · Procedure: Prostate biopsy · Procedure: Periprostatic nerve block
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).
Procedure: Trans rectal ultrasound guided prostate biopsy · Procedure: Trans rectal ultrasound · Procedure: Prostate biopsy · Procedure: Periprostatic nerve block
Anal application of lidocaine cream 5% for 20 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).
Procedure: Trans rectal ultrasound guided prostate biopsy · Procedure: Trans rectal ultrasound · Procedure: Prostate biopsy · Procedure: Periprostatic nerve block
Anal application plus intrarectal application of 5% lidocaine cream 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).
Procedure: Trans rectal ultrasound guided prostate biopsy · Procedure: Trans rectal ultrasound · Procedure: Prostate biopsy · Procedure: Periprostatic nerve block
Anal application plus intrarectal application of 5% lidocaine cream 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).
Procedure: Trans rectal ultrasound guided prostate biopsy · Procedure: Trans rectal ultrasound · Procedure: Prostate biopsy · Procedure: Periprostatic nerve block
Anal application plus intrarectal application of 5% lidocaine cream for 20 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).
Procedure: Trans rectal ultrasound guided prostate biopsy · Procedure: Trans rectal ultrasound · Procedure: Prostate biopsy · Procedure: Periprostatic nerve block
No anal application of lidocaine cream prior to 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).
Procedure: Trans rectal ultrasound guided prostate biopsy · Procedure: Trans rectal ultrasound · Procedure: Prostate biopsy · Procedure: Periprostatic nerve block
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
Also known as: 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)
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.
Time frame: Before transrectal ultrasound probe insertion
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.
Time frame: During transrectal ultrasound probe insertion into the rectum (defined as beginning of procedure)
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.
Time frame: During transrectal ultrasound probe manipulation in the rectum (estimated at 0-2 minutes length)
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.
Time frame: During periprostatic nerve block (rectal wall puncture with needle, estimated at 2-3 minutes after beginning of procedure)
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.
Time frame: During biopsy collection using an 18-gauge needle (estimated at 3-10 minutes from beginning of procedure)
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.
Time frame: At termination of procedure (total estimated length of procedure is 10 minutes).
No study locations are listed for this record.
Plan to share: No
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Assaf-Harofeh Medical Center