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

Shamir Medical Center (Assaf-Harofeh)

Status: Completed

Conditions: Prostate Cancer; Pain; Rectal/Anal

Treatments: Procedure: Prostate biopsy; Procedure: Trans rectal ultrasound guided prostate biopsy; Procedure: Trans rectal ultrasound; Procedure: Periprostatic nerve block

Study type: Interventional

Funder types: Other

Identifiers

NCT04064047

Assaf-HarofehMC 0289-15-ASF

Details and patient eligibility

About

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.

Full 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.

Enrollment: 284 patients

Sex: Male

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

---

284 participants in 7 patient groups

External Anal application - 5 minutes exposure

Active Comparator group

Description:

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).

Treatment:

Procedure: Periprostatic nerve block

Procedure: Trans rectal ultrasound

Procedure: Trans rectal ultrasound guided prostate biopsy

Procedure: Prostate biopsy

External Anal application - 10 minutes exposure

Active Comparator group

Description:

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).

Treatment:

Procedure: Periprostatic nerve block

Procedure: Trans rectal ultrasound

Procedure: Trans rectal ultrasound guided prostate biopsy

Procedure: Prostate biopsy

External Anal application - 20 minutes exposure

Active Comparator group

Description:

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).

Treatment:

Procedure: Periprostatic nerve block

Procedure: Trans rectal ultrasound

Procedure: Trans rectal ultrasound guided prostate biopsy

Procedure: Prostate biopsy

External Anal plus intrarectal - 5 minutes exposure

Active Comparator group

Description:

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).

Treatment:

Procedure: Periprostatic nerve block

Procedure: Trans rectal ultrasound

Procedure: Trans rectal ultrasound guided prostate biopsy

Procedure: Prostate biopsy

External Anal plus intrarectal - 10 minutes exposure

Active Comparator group

Description:

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).

Treatment:

Procedure: Periprostatic nerve block

Procedure: Trans rectal ultrasound

Procedure: Trans rectal ultrasound guided prostate biopsy

Procedure: Prostate biopsy

External Anal plus intrarectal - 20 minutes exposure

Active Comparator group

Description:

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).

Treatment:

Procedure: Periprostatic nerve block

Procedure: Trans rectal ultrasound

Procedure: Trans rectal ultrasound guided prostate biopsy

Procedure: Prostate biopsy

Control group

Sham Comparator group

Description:

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).

Treatment:

Procedure: Periprostatic nerve block

Procedure: Trans rectal ultrasound

Procedure: Trans rectal ultrasound guided prostate biopsy

Procedure: Prostate biopsy