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临床试验/NCT02935972
NCT02935972已完成2 期

Pain Reduction During Transrectal Ultrasound-guided Biopsy of the Prostate: Intravenous Diazepam, Local Periprostatic Nerve Block or Combination

Assiut University1 个研究点 分布在 1 个国家目标入组 336 人开始时间: 2013年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
336
试验地点
1
主要终点
Visual Analogue Score

研究概览

简要总结

Prostate biopsy under transrectal ultrasound (TRUS) guidance is considered the procedure of choice for diagnosing prostate cancer. And as in any other diagnostic biopsy procedures; patients perceive anxiety before, during and after biopsy and ultrasound guided prostate biopsy is not an exclusion.

TRUS guided prostatic biopsies are mainly performed in an outpatient clinic, men undergoing transrectal prostate biopsy experience considerable psychological stress. It may be attributable to the fear of the potential diagnosis of cancer, the anal route of penetration, the fact that the subject organ examined is part of the sexual system and the anticipated pain and as a matter of fact the issues of discomfort and pain perceived throughout the procedure referred to the negative impact of the whole procedure, that is probe insertion and biopsy punctures.

Thus it is essential to employ a simple method that can liberate the patient from pain during prostate biopsy. Some studies recommend sedation , others recommend intra-rectal lidocaine gel and others periprostatic nerve block while others recommend Nitrous oxide inhalation as an effective method of analgesia for the procedural related pain or discomfort of prostate biopsy. The employment of analgesics, sedation and/or narcotic medication may alleviate much of the discomfort associated with transrectal prostate biopsy, such treatment may be associated with additional risks. Furthermore, when systemic medication is administered, patients require conscious sedation monitoring during and after the procedure, which may be inconvenient and relatively expensive in addition to their unsuitability to be performed on outpatient clinic basis. Therefore, a simple form of anesthesia is desirable.

Although a wide variety of anesthetic techniques are available for transrectal ultrasound-guided prostate biopsy, including rectal administration of lidocaine gel, periprostatic nerve blocks, intravenous propofol, and narcotic intramuscular premedication, these methods may not optimally prevent or relieve pain.

详细描述

From November 2013 to November 2014, 336 patients fitted our inclusion criteria underwent transrectal ultrasound-guided prostate biopsy (TRUSPB).

Informed consent was obtained from all patients after detail description of the study.

Bowel preparation with cleansing enema (a sodium phosphate and dibasic sodium phosphate enema) and antibiotic prophylaxis with Levofloxacin 500 mg. was prescribed.

Patients were randomized into three equal groups where Group I: to receive intravenous diazepam 5 mg slowly just before probe insertion Group II: received 10 cc of 1% Lidocaine injected into the periprostatic nerve plexus bilaterally under ultrasound guidance using a 22 gauge 7 inch needle , prior to injection caution was taken to aspirate before injection to avoid accidental intravascular injection of lidocaine, proper needle placement and injection of lidocaine a sonographic hypoechogenicity is created between the rectal wall and the base of the seminal vesicles causing the seminal vesicles to separate from the rectal wall and appear to be raised (fig.1) prostate biopsies had begun 2 to 3 minutes after lidocaine injection. Group III: intravenous diazepam 5 mg slowly just before probe insertion and 10 cc of 1% Lidocaine injected into the periprostatic nerve plexus bilaterally under ultrasound guidance.

Prostatic biopsies was performed in combined directed and random technique or extended random technique in absence of focal abnormality with mean number of biopsies 10 biopsies (9 to 12 biopsy) were done per patient.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
40 Years 至 95 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • abnormal digital rectal examination
  • elevated PSA
  • focal abnormality in TRUS.

排除标准

  • previous allergy to diazepam or lidocaine
  • bleeding diathesis or anticoagulant therapy
  • history of chronic prostatitis
  • acute anal and rectal conditions (as haemorrhoids, anal fissures or strictures)
  • neurological conditions
  • patients with respiratory asthma or chronic liver diseases

研究组 & 干预措施

Diazepam

Active Comparator

received intravenous diazepam 5 mg slowly just before TRUS probe insertion

干预措施: Diazepam (Drug)

Local

Active Comparator

received 10 cc of 1% Lidocaine injected into the periprostatic nerve plexus bilaterally under ultrasound guidance

干预措施: Lidocaine 1% (Drug)

Combined

Active Comparator

received intravenous diazepam 5 mg slowly just before TRUS probe insertion and 10 cc of 1% Lidocaine injected into the periprostatic nerve plexus bilaterally under ultrasound guidance

干预措施: Diazepam and Lidocaine 1% (Drug)

结局指标

主要结局

Visual Analogue Score

时间窗: 2 hours

degree of pain during prostate biopsy

次要结局

  • Sedation Score(2 hours)
  • Complications(2 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

MOHAMED F. MOSTAFA

lecturer of anesthesia and intensive care

Assiut University

研究点 (1)

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