Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12619001760167
Ethics application status
Approved
Date submitted
8/10/2019
Date registered
11/12/2019
Date last updated
11/12/2019
Date data sharing statement initially provided
11/12/2019
Date results information initially provided
11/12/2019
Type of registration
Retrospectively registered
Titles & IDs
Public title
Efficacy and safety of three different analgesic methods for patients undergoing transrectal ultrasound-guided prostate biopsy: a prospective, randomized controlled trial.
Query!
Scientific title
Efficacy and safety of three different analgesic methods for patients undergoing transrectal ultrasound-guided prostate biopsy: a prospective, randomized controlled trial.
Query!
Secondary ID [1]
299330
0
Nil known
Query!
Universal Trial Number (UTN)
U1111-1240-5658
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Prostate cancer
314472
0
Query!
Pain relief
314474
0
Query!
Condition category
Condition code
Cancer
312808
312808
0
0
Query!
Prostate
Query!
Renal and Urogenital
312809
312809
0
0
Query!
Other renal and urogenital disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Arm 1: Urologist on duty for prostate biopsy procedure administered an intramuscular injection of Tramadol 100mg/ml, one hour prior to prostate biopsy procedure as adjunct regimen to the current gold standard of care method for preventing pain during transrectal ultrasound-guided biopsy, known as periprostatic nerve block (PPNB) anesthesia by injecting 10ml of Lidocaine 1% bilaterally at neurovascular bundles of prostate gland five minutes prior the actual biopsy process (obtaining of prostate cores) of prostate biopsy procedure.
Arm 2: Urologist on duty for prostate biopsy procedure administered the intramuscular injections of Tramadol 100mg/ml and Parecoxib 40mg/ml, one hour prior to prostate biopsy procedure as adjunct regimens to the current gold standard of care method for preventing pain during transrectal ultrasound-guided biopsy, known as periprostatic nerve block (PPNB) anesthesia by injecting 10ml of Lidocaine 1% bilaterally at neurovascular bundles of prostate gland five minutes prior the actual biopsy process (obtaining of prostate cores) of prostate biopsy procedure.
Query!
Intervention code [1]
315599
0
Treatment: Drugs
Query!
Intervention code [2]
315600
0
Prevention
Query!
Comparator / control treatment
Bilateral injection of 10ml of Lidocaine 1% at neurovascular bundles of prostate gland, known as periprostatic nerve block (PPNB) anesthesia. The injection was performed five minutes before the actual biopsy process of prostate biopsy procedure.
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
321430
0
The efficacy of examined drugs (Tramadol alone or in combination with Parecoxib) as adjunct regimens to PPNB anesthesia. The efficacy was assessed by the difference in mean value of numeric rating scale (NRS) of pain, ranging from 0 to 10 points, with zero corresponding to no pain or discomfort and 10 corresponding to worst possible pain or discomfort.
Query!
Assessment method [1]
321430
0
Query!
Timepoint [1]
321430
0
Immediately after completion of each particular step of prostate biopsy procedure, participants were asked to assess the pain experienced at three consecutive time-periods: (i) at the time of probe insertion (NRS1), (ii) at the time of PPNB anesthesia (NRS2) and (iii) at the time of actual biopsy itself (NRS3), on a numeric rating scale (NRS) of pain.
Query!
Secondary outcome [1]
374931
0
The safety evaluated by occurrence of post-procedural complications and adverse effects related to each analgesic study protocol alone, as well as, compared to the current gold standard technique (PPNB).
Complications and adverse effects were graded as:
(i )Severe, including: syncope episode or hypotension requiring intravenous fluid and/or atropine, allergic reactions, hematuria and rectal bleeding requiring hospitalization, acute urinary retention, urosepsis or any kind of intervention.
(ii) Mild, including: self-limiting hematuria, fever (>38,0C) and rectal bleeding.
Post-procedural complications and adverse effects were presented in total counts and percentages.
Query!
Assessment method [1]
374931
0
Query!
Timepoint [1]
374931
0
Participants were monitored up to 2 hours after biopsy completion in order to record any potential severe complication and/or adverse effect related to the study interventions,
Post-procedural complications and adverse effects related to the prostate biopsy procedure were interviewed by telephone 72 hours later. The questions were phrased in the same manner for all participants to minimize any bias during data collection.
Query!
Secondary outcome [2]
374932
0
The difference in anxiety feeling of participants, experienced during the pre- and post-procedural period, The anxiety test (Likert Anxiety Scale) evaluated the intensity of nine similar symptoms on a linear analogue scale, ranging from 0 to 10 points, with zero corresponding to no intensity and 10 corresponding to extreme intensity feeling. Results of anxiety test were presented in mean values.
Query!
Assessment method [2]
374932
0
Query!
Timepoint [2]
374932
0
Upon enrollment of participants in the trial, a questionnaire (Pre-procedural Likert Anxiety Scale) was provided in order to assess the intensity of anxiety feeling experienced before any interventional procedure.
Participants were interviewed 2 hours after biopsy completion in order to complete a questionnaire regarding their anxiety feeling (Post-procedural Likert Anxiety Scale).
Query!
Secondary outcome [3]
374933
0
The satisfaction of participants related to the pain relief, experienced during each analgesic study arm. The satisfaction of pain relief was assessed by “Post-procedural Questionnaire”. Post-procedural Questionnaire was composed by four questionson with five possible answers for each question on a linear analogue scale, ranging from the least to the greatest extent of satisfaction. Results of satisfaction test were presented in total counts and percentages.
1) What word best describes the pain experienced during the biopsy?
No pain Mild discomfort Distressing Horrible Excruciating
2) Which word best describes the pain experienced after the biopsy?
No pain Mild discomfort Distressing Horrible Excruciating
3) Overall, how comfortable was the entire procedure?
Not at all easy Not very easy Easy Fairly easy Very easy
4) If medically necessary, how willing would you be to return for this procedure?
Not at all easy Not very easy Easy Fairly easy Very easy
Query!
Assessment method [3]
374933
0
Query!
Timepoint [3]
374933
0
Participants were interviewed 2 hours after biopsy completion in order to complete a questionnaire regarding their satisfaction in relation to pain relief (Post-procedural Questionnaire).
Query!
Eligibility
Key inclusion criteria
All consecutive patients referred to Urology Department for early detection of prostate cancer due to increased serum PSA, and/or abnormal digital rectal examination or transrectal ultrasound-guided findings were considered eligible for the present study.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Males
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Exclusion criteria were: history of previous prostate biopsy, active anorectal pathology (anal fissures, strictures, hemorrhoids), chronic prostatitis/pelvic pain syndrome, concomitant analgesic medication, known allergy to investigating analgesic regimens, contraindications to NSAIDs such as gastric or duodenal ulcers, patients with bleeding diathesis and those with impaired intellectual ability.
Query!
Study design
Purpose of the study
Prevention
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All consecutive patients that were referred to Urology Department for prostate biopsy and that had had fullfilled inclusion criteria were randomly allocated into three study-arms, by the use of an electronic platform generator of randomized permuted blocks.
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Factorial
Query!
Other design features
Query!
Phase
Phase 2 / Phase 3
Query!
Type of endpoint/s
Safety/efficacy
Query!
Statistical methods / analysis
The primary outcome was the evaluation of efficacy as assessed by the difference in mean NRS score between the three study groups. The secondary outcomes were the evaluation of safety, anxiety and satisfaction of participants in comparison between the three study groups. To detect statistically significant differences of such magnitude with 81% power and a 2-sided 5% significance level using ANOVA with 2 df contrasts approximately 11 patients per group were required. All continuous variables of participants’ characteristics were found to be normally distributed according to Shapiro-Wilk test and they were reported as the mean ± SD and Min-Max values. Differences in patient characteristics for continuous variables were calculated by the use of one-way analysis of variance (ANOVA) with a =0.05. Categorical variables were reported as frequencies and relative frequencies. Cochran's rule was accepted therefore the chi-square test with a = 0.05 was used.
The assess of normality for NRS scores between participants in group 1, 2 and 3 was suggested that data were not normally distributed, thus the non-parametric Mann-Whitney U test was used. Differences in complication rate were reported with frequencies and relative frequencies and they were assessed by the use of Fisher’s exact test because Cochran's rule was not accepted. The Bonferroni correction with a = 0.0167 was used for adjusting the p-values.
The assess of normality for anxiety scores between participants in group 1, 2 and 3 suggested that data were normally distributed, thus the parametric two-way analysis of variance (ANOVA) with a = 0.05 was used. The Paired t-test was further used to determine which specific pairs of group demonstrate statistically significant differences. Differences in satisfaction of participants related to prostate biopsy procedure were reported with frequencies and relative frequencies and they were assessed by the use of chi-squared test because Cochran's rule was accepted. The Mann-Whitney U test was further used to determine which specific pairs of group demonstrates statistically significant differences between all four questions. The Bonferroni correction with a = 0.0167 was used for adjusting the p-values. All analysis was performed using R, version 3.5.0.
Query!
Recruitment
Recruitment status
Completed
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
9/10/2017
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
15/03/2018
Query!
Date of last data collection
Anticipated
Query!
Actual
18/03/2018
Query!
Sample size
Target
51
Query!
Accrual to date
Query!
Final
51
Query!
Recruitment outside Australia
Country [1]
21878
0
Greece
Query!
State/province [1]
21878
0
Thessaloniki
Query!
Funding & Sponsors
Funding source category [1]
303846
0
Self funded/Unfunded
Query!
Name [1]
303846
0
Xenofon Ouzounidis
Query!
Address [1]
303846
0
General Hospital of Thessaloniki "Papageorgiou", Ring Road, N.Eykarpias, Thessaloniki, Greece, 56429
Query!
Country [1]
303846
0
Greece
Query!
Primary sponsor type
Individual
Query!
Name
Xenofon Ouzounidis
Query!
Address
General Hospital of Thessaloniki "Papageorgiou", Ring Road, N.Eykarpias, Thessaloniki, Greece, 56429
Query!
Country
Greece
Query!
Secondary sponsor category [1]
304018
0
Individual
Query!
Name [1]
304018
0
Konstantinos Hatzimouratidis
Query!
Address [1]
304018
0
General Hospital of Thessaloniki "Papageorgiou", Ring Road, N.Eykarpias, Thessaloniki, Greece, 56429
Query!
Country [1]
304018
0
Greece
Query!
Secondary sponsor category [2]
304164
0
Individual
Query!
Name [2]
304164
0
Kiriakos Moysidis
Query!
Address [2]
304164
0
General Hospital of Thessaloniki "Papageorgiou", Ring Road, N.Eykarpias, Thessaloniki, Greece, 56429
Query!
Country [2]
304164
0
Greece
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
304359
0
Hellenic Republic, Ministry of Health, Macedonian 3rd District Health Administration, Human Resources Development Unit, Health and Social Solidarity Units, Continuing Education and International Partnerships
Query!
Ethics committee address [1]
304359
0
Aristotelous 16, Thessaloniki, Greece, 54623
Query!
Ethics committee country [1]
304359
0
Greece
Query!
Date submitted for ethics approval [1]
304359
0
20/06/2018
Query!
Approval date [1]
304359
0
02/08/2018
Query!
Ethics approval number [1]
304359
0
D3ß/28896
Query!
Summary
Brief summary
Recent studies have found that PPNB anesthesia effectively relieves pain due to insertion of the biopsy needle into the prostate gland (actual biopsy) but it is ineffective in reducing the pain caused by probe insertion into the rectum during TRUS-guided prostate biopsy procedure. In this regard, if adjunct regimens are added prior to PPNB anesthesia, pain experienced during TRUS-guided prostate biopsy may be alleviated. The study purpose is to investigate the efficacy and safety of Tramadol alone or in combination with Parecoxib as adjuncts regimens to PPNB anesthesia in the management of pain during TRUS-guided prostate gland biopsy and compared to current gold standard procedure, PPNB anesthesia, alone.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Ethics approval was requested prior to enrollment of the first participant in the study protocol by the responsible department of ethics issues in the corresponding hospital which requested a further approval by the Hellenic Republic, Ministry of Health, Macedonian 3rd District Health Administration, Human Resources Development Unit, Health and Social Solidarity Units, Continuing Education and International Partnerships. Bureaucratic process takes long time.
Query!
Contacts
Principal investigator
Name
96678
0
Mr Xenofon Ouzounidis
Query!
Address
96678
0
General Hospital of Thessaloniki "Papageorgiou", Ring Road, N.Eykarpias, Thessaloniki, Greece, 56429
Query!
Country
96678
0
Greece
Query!
Phone
96678
0
+302313323150
Query!
Fax
96678
0
Query!
Email
96678
0
[email protected]
Query!
Contact person for public queries
Name
96679
0
Mr Xenofon Ouzounidis
Query!
Address
96679
0
General Hospital of Thessaloniki "Papageorgiou", Ring Road, N.Eykarpias, Thessaloniki, Greece, 56429
Query!
Country
96679
0
Greece
Query!
Phone
96679
0
+302313323150
Query!
Fax
96679
0
Query!
Email
96679
0
[email protected]
Query!
Contact person for scientific queries
Name
96680
0
Mr Xenofon Ouzounidis
Query!
Address
96680
0
General Hospital of Thessaloniki "Papageorgiou", Ring Road, N.Eykarpias, Thessaloniki, Greece, 56429
Query!
Country
96680
0
Greece
Query!
Phone
96680
0
+302313323150
Query!
Fax
96680
0
Query!
Email
96680
0
[email protected]
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
All of the individual participant data collected during the trial except of personal information (e.g. ID number, name, date of prostate biopsy, telephone number).
Query!
When will data be available (start and end dates)?
Immediately following publication, no end date determined
Query!
Available to whom?
Only researchers who provide a methodologically sound proposal
Query!
Available for what types of analyses?
Only to achieve the aims in the approved proposal, especially for those with IPD meta-analyses purposes
Query!
How or where can data be obtained?
Data will be provided to the corresponding journal for publishing my research study and will be available upon request to the corresponding journal
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
4988
Ethical approval
[email protected]
378405-(Uploaded-20-09-2019-05-24-30)-Study-related document.pdf
4989
Informed consent form
[email protected]
This is the "inform consent form" for participants...
[
More Details
]
378405-(Uploaded-20-09-2019-05-29-45)-Study-related document.pdf
4990
Informed consent form
[email protected]
This is the "inform consent form" for participants...
[
More Details
]
378405-(Uploaded-20-09-2019-05-30-40)-Study-related document.pdf
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Efficacy and safety of three different analgesic methods for patients undergoing transrectal ultrasound-guided prostate biopsy: a prospective, randomized controlled trial.
2020
N.B. These documents automatically identified may not have been verified by the study sponsor.
Download to PDF