Anorectal Application of 5% Lidocaine Cream Reduces Pain Prior to Periprostatic Nerve Block During Transrectal Ultrasound Guided Biopsy: Randomized, Prospective Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 284
- 主要终点
- Pain level during TRUS probe manipulation in the rectum
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Known sensitivity to Lidocaine
- •Pre-planned biopsy under general anesthesia
研究组 & 干预措施
External Anal application - 5 minutes exposure
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).
干预措施: Trans rectal ultrasound guided prostate biopsy (Procedure)
External Anal application - 5 minutes exposure
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).
干预措施: Trans rectal ultrasound (Procedure)
External Anal application - 5 minutes exposure
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).
干预措施: Prostate biopsy (Procedure)
External Anal plus intrarectal - 5 minutes exposure
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).
干预措施: Trans rectal ultrasound guided prostate biopsy (Procedure)
External Anal application - 5 minutes exposure
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).
干预措施: Periprostatic nerve block (Procedure)
External Anal application - 10 minutes exposure
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).
干预措施: Trans rectal ultrasound guided prostate biopsy (Procedure)
External Anal application - 10 minutes exposure
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).
干预措施: Trans rectal ultrasound (Procedure)
External Anal application - 10 minutes exposure
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).
干预措施: Prostate biopsy (Procedure)
External Anal application - 10 minutes exposure
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).
干预措施: Periprostatic nerve block (Procedure)
External Anal application - 20 minutes exposure
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).
干预措施: Trans rectal ultrasound guided prostate biopsy (Procedure)
External Anal application - 20 minutes exposure
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).
干预措施: Trans rectal ultrasound (Procedure)
External Anal application - 20 minutes exposure
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).
干预措施: Prostate biopsy (Procedure)
External Anal application - 20 minutes exposure
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).
干预措施: Periprostatic nerve block (Procedure)
External Anal plus intrarectal - 5 minutes exposure
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).
干预措施: Trans rectal ultrasound (Procedure)
External Anal plus intrarectal - 5 minutes exposure
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).
干预措施: Prostate biopsy (Procedure)
External Anal plus intrarectal - 5 minutes exposure
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).
干预措施: Periprostatic nerve block (Procedure)
External Anal plus intrarectal - 10 minutes exposure
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).
干预措施: Trans rectal ultrasound guided prostate biopsy (Procedure)
External Anal plus intrarectal - 10 minutes exposure
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).
干预措施: Trans rectal ultrasound (Procedure)
External Anal plus intrarectal - 10 minutes exposure
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).
干预措施: Prostate biopsy (Procedure)
External Anal plus intrarectal - 10 minutes exposure
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).
干预措施: Periprostatic nerve block (Procedure)
External Anal plus intrarectal - 20 minutes exposure
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).
干预措施: Trans rectal ultrasound guided prostate biopsy (Procedure)
External Anal plus intrarectal - 20 minutes exposure
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).
干预措施: Trans rectal ultrasound (Procedure)
External Anal plus intrarectal - 20 minutes exposure
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).
干预措施: Prostate biopsy (Procedure)
External Anal plus intrarectal - 20 minutes exposure
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).
干预措施: Periprostatic nerve block (Procedure)
Control group
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).
干预措施: Trans rectal ultrasound guided prostate biopsy (Procedure)
Control group
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).
干预措施: Trans rectal ultrasound (Procedure)
Control group
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).
干预措施: Prostate biopsy (Procedure)
Control group
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).
干预措施: Periprostatic nerve block (Procedure)
结局指标
主要结局
Pain level during TRUS probe manipulation in the rectum
时间窗: 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 at TRUS probe insertion
时间窗: 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 before probe insertion
时间窗: 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 during periprostatic nerve block
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点