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

Combined Intravenous Diazepam, Local Periprostatic Nerve Block for Prostate Biopsy

Sponsors

Lead sponsor: Assiut University

Source Assiut University
Brief 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).

Overall Status Completed
Start Date November 2013
Completion Date January 2015
Primary Completion Date November 2014
Phase Phase 2/Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Visual Analogue Score 2 hours
Secondary Outcome
Measure Time Frame
Sedation Score 2 hours
Complications 2 hours
Enrollment 336
Condition
Intervention

Intervention type: Drug

Intervention name: Diazepam

Description: received intravenous diazepam 5 mg slowly just before TRUS probe insertion

Arm group label: Diazepam

Intervention type: Drug

Intervention name: Lidocaine 1%

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

Arm group label: Local

Intervention type: Drug

Intervention name: Diazepam and Lidocaine 1%

Description: 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

Arm group label: Combined

Eligibility

Criteria:

Inclusion Criteria:

- abnormal digital rectal examination

- elevated PSA

- focal abnormality in TRUS.

Exclusion Criteria:

- 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

Gender: Male

Minimum age: 40 Years

Maximum age: 95 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
HAMDY A. YOUSSEF, MD Study Director Assiut University
Location
facility
Assiut university hospital
Location Countries

Egypt

Verification Date

January 2017

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Assiut University

Investigator full name: MOHAMED F. MOSTAFA

Investigator title: lecturer of anesthesia and intensive care

Keywords
Has Expanded Access No
Number Of Arms 3
Arm Group

Arm group label: Diazepam

Arm group type: Active Comparator

Description: received intravenous diazepam 5 mg slowly just before TRUS probe insertion

Arm group label: Local

Arm group type: Active Comparator

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

Arm group label: Combined

Arm group type: Active Comparator

Description: 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

Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: None (Open Label)

Source: ClinicalTrials.gov