Pain Relief During Prostate BiopsyPhase 2/3NCT02935972
Combined Intravenous Diazepam, Local Periprostatic Nerve Block for Prostate Biopsy
A Phase 2/3 study testing Diazepam, Lidocaine 1% and Diazepam and Lidocaine 1% in people with Pain Relief During Prostate Biopsy, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 95 years, men only
- Conditions the study is for
- Pain Relief During Prostate Biopsy
- What is being tested?
- Diazepam, Lidocaine 1% and Diazepam and Lidocaine 1%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 336 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2013to Jan 2015
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 95 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- abnormal digital rectal examination
- elevated PSA
- focal abnormality in TRUS.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain Reduction During Transrectal Ultrasound-guided Biopsy of the Prostate: Intravenous Diazepam, Local Periprostatic Nerve Block or Combination
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.
Read more
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.
Read the 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).
- Conditions
- Pain Relief During Prostate Biopsy
- Being tested
- Diazepam, Lidocaine 1%, Diazepam and Lidocaine 1%
- Keywords
- prostate biopsy, analgesia, anesthesia, pain, prostate cancer
- Medical subject headings
- Agnosia, Pain, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiazepamDrug
received intravenous diazepam 5 mg slowly just before TRUS probe insertion
Lidocaine 1%Drug
received 10 cc of 1% Lidocaine injected into the periprostatic nerve plexus bilaterally under ultrasound guidance
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
| Study group | Role | What they receive |
|---|---|---|
| Diazepam | Active comparator | received intravenous diazepam 5 mg slowly just before TRUS probe insertion Receives: Drug: Diazepam |
| Local | Active comparator | received 10 cc of 1% Lidocaine injected into the periprostatic nerve plexus bilaterally under ultrasound guidance Receives: 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 Receives: Drug: Diazepam and Lidocaine 1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Score
degree of pain during prostate biopsy
Measured: 2 hours
Secondary outcomes (2)
Sedation Score
degree of sedation during prostate biopsy
Measured: 2 hours
Complications
hematuria, haematochezia or infection were recorded
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study startNov 2013
- Primary completionNov 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain Relief During Prostate BiopsyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 336 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MOHAMED F. MOSTAFA, Assiut University
- Investigators
- HAMDY A. YOUSSEF, MD, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02935972
- Sponsor's protocol ID
- Diazepam and TRUS Biopsy
- Status last verified
- Jan 2017
- First submitted
- 13 Oct 2016
- Last updated
- 23 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Reduction During Transrectal Ultrasound-guided Biopsy of the Prostate: Intravenous Diazepam, Local Periprostatic Nerve Block or Combination
- ClinicalTrials.gov ID
- NCT02935972
- Acronym / sponsor ID
- Diazepam and TRUS Biopsy
- Conditions
- Pain Relief During Prostate Biopsy
- Keywords
- prostate biopsy, analgesia, anesthesia, pain, prostate cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 336 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2013 (actual)
- Primary completion
- Nov 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 18 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diazepam | Active comparator | Drug: Diazepamreceived intravenous diazepam 5 mg slowly just before TRUS probe insertion |
| Local | Active comparator | Drug: Lidocaine 1%received 10 cc of 1% Lidocaine injected into the periprostatic nerve plexus bilaterally under ultrasound guidance |
| Combined | Active comparator | Drug: Diazepam and Lidocaine 1%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 |
Who may qualify
- Ages
- 40 to 95 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- abnormal digital rectal examination
- elevated PSA
- focal abnormality in TRUS.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diazepamreceived intravenous diazepam 5 mg slowly just before TRUS probe insertion | Drug | Diazepam |
| Lidocaine 1%received 10 cc of 1% Lidocaine injected into the periprostatic nerve plexus bilaterally under ultrasound guidance | Drug | Local |
| Diazepam and Lidocaine 1%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 | Drug | Combined |
Primary outcome
Visual Analogue Score
Time frame: 2 hours
degree of pain during prostate biopsy
2 secondary outcomes
Sedation Score
Time frame: 2 hours
Complications
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Pain Relief During Prostate Biopsy
Active, not recruiting
AcuTENS for Pain Relief During TRUS-Guided Prostate Biopsy
Prostate Cancer, Procedural Pain Relief
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
HAMDY A. YOUSSEF, MD study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Diazepam, Lidocaine 1% and Diazepam and Lidocaine 1% in people with Pain Relief During Prostate Biopsy, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Score (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2017.