Combined Intravenous Diazepam, Local Periprostatic Nerve Block for Prostate Biopsy

NCT02935972 | Completed Phase 2 DMC

• 1 other identifier: Diazepam and TRUS Biopsy
• Study Type: interventional
• Target: 336
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain Relief During Prostate Biopsy

Keywords

prostate biopsy, analgesia, anesthesia, pain, prostate cancer

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Score

  degree of pain during prostate biopsy

  2 hours

Secondary Outcomes (2)

• Sedation Score

  2 hours

• Complications

  2 hours

Study Arms (3)

Diazepam

ACTIVE COMPARATOR

received intravenous diazepam 5 mg slowly just before TRUS probe insertion

Drug: Diazepam

Local

ACTIVE COMPARATOR

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

Drug: Lidocaine 1%

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

Drug: Diazepam and Lidocaine 1%

Interventions

Diazepam DRUG

received intravenous diazepam 5 mg slowly just before TRUS probe insertion

Diazepam

Lidocaine 1% DRUG

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

Local

Diazepam and Lidocaine 1% DRUG

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

Combined

Eligibility Criteria

• Age: 40 Years - 95 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university hospital

Asyut, Asyut Governorate, 71515, Egypt

Location

MeSH Terms

Conditions

Agnosia; Pain; Prostatic Neoplasms

Interventions

Diazepam; Lidocaine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• HAMDY A. YOUSSEF, MD

  Assiut University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia and intensive care

Study Record Dates

• First Submitted: October 13, 2016
• First Posted: October 18, 2016
• Study Start: November 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: January 1, 2015
• Last Updated: January 23, 2017

Record last verified: 2017-01

Locations

EG (1)