Combined Intravenous Diazepam, Local Periprostatic Nerve Block for Prostate Biopsy
Condition: Pain Relief During Prostate Biopsy
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      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.
    

Detailed description: 
      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.

      The sedation scale were evaluated according to sedation scale. After the procedure,
      discomfort and pain experienced during performing the biopsy technique were graded using a
      10-point linear visual analog pain scale.

      All patients were monitored during and after the procedure for possible complications,
      patients were also questioned regarding any adverse effect at one week duration (at the time
      of receiving the histopathological results).
    

Intervention name(s): Diazepam; Lidocaine 1%; Diazepam and Lidocaine 1%
Intervention type(s): Drug; Drug; Drug
Intervention description(s): received intravenous diazepam 5 mg slowly just before TRUS probe insertion; received 10 cc of 1% Lidocaine injected into the periprostatic nerve plexus bilaterally under ultrasound guidance; received 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
Intervention MeSH terms: Lidocaine; Diazepam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: prostate biopsy, analgesia, anesthesia, pain, prostate cancer