Evaluation of oral pregabalin and local anesthesia simultaneous administration effect on pain of patients undergoing prostate biopsy refered to imam hospital of Urmia
Evaluation of oral pregabalin and local anesthesia simultaneous administration effect on pain of patients undergoing prostate biopsy referred to imam hospital of Urmia
Design
After stratification and randomization, all of patients basic information, will be collect and divided to 2 groups:
first, undergone TRUS biopsy of prostate under local anesthesia with Lidocaine
second, those have given 100 mg Pregabalin Cap 6 hours before the procedure despite of their BMI and then go on TRUS biopsy of prostate .
All of patients will get Lat Decubitus or Lithotomy position for their biopsy . Trans rectal US probe will be prepare for biopsy localizing and then go under TRUS biopsy of prostate with biopsy needle . 18 G needle attaached to US probe will be use.
And then pain after biopsy , 1 an 6 hour ,will be questioned by a nurse in recovery room in operation ward due to pain analog questionnaire.
Settings and conduct
Referred patients to Urmia Imam Khomeini Hospital
Participants/Inclusion and exclusion criteria
Inclusion criterion: male patients with PSA ≥4.0 ng/mL. Exclusion criteria: lithotomy position for prostate biopsy is impossible for participants; prior pelvic pain before prostate biopsy; TURP history; hormonal therapy or radiotherapy history; existing any ano-rectal pathology
Intervention groups
Control group use local anesthesia with Lidocaine gel and intervention group will receive single oral dose of 100mg Pregabaline an hour before of biopsy,
Main outcome variables
Pain after prostate biopsy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200205046388N1
Registration date:2020-11-16, 1399/08/26
Registration timing:registered_while_recruiting
Last update:2020-11-16, 1399/08/26
Update count:0
Registration date
2020-11-16, 1399/08/26
Registrant information
Name
Hossein Aghamohamadpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3198 8749
Email address
aghamohamadpour.h@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-10, 1399/08/20
Expected recruitment end date
2020-12-10, 1399/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of oral pregabalin and local anesthesia simultaneous administration effect on pain of patients undergoing prostate biopsy refered to imam hospital of Urmia
Public title
Evaluation of oral pregabalin administration on pain of patients undergoing prostate biopsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male patients with PSA ≥4.0 ng/mL
Lithotomy position for prostate biopsy is possible for participants
Exclusion criteria:
Prior pelvic pain before prostate biopsy
TURP history
Hormonal therapy or radiotherapy history
Existing any Ano-rectal pathology
Age
From 20 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is based on blocks stratification and triple blind clinical trial, any patients will received any placebo or pregabalin cap. randomly. after determination of patients number (52 patients), according to epidemiological methods ,they stratified to A or B randomly and will receive placibo or pregabalin cap. according seal up pockets specified A or B.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Because of placebo and drugs similarity, not only the participants but also the primary nurse prescribe the drugs, will not informed of basic trial and then the nurse who will collect data will not be known kind of prescribed capsule.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Urmia University of Medical Sciences
Street address
Vice chancellor for resaerch, Central building of UMSU. Resalat Avn.
City
Urmia
Province
West Azarbaijan
Postal code
3175874867
Approval date
2020-01-29, 1398/11/09
Ethics committee reference number
IR.UMSU.REC.1398.466
Health conditions studied
1
Description of health condition studied
Prostate cancer
ICD-10 code
C61
ICD-10 code description
Malignant neoplasm of prostate
Primary outcomes
1
Description
Pain after prostate biopsy
Timepoint
1 and 6 hours after biopsy
Method of measurement
Pain Analogue Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: single dose of PREGABALIN SOBHAN DAROU (Iran), 100MG CAP will prescribe in patients which be under routine TRUS biopsy prostate with Lidocaine local anesthesia, one hour before than biopsy.
Category
Treatment - Drugs
2
Description
Control group: patients underwent prostate biopsy with routine Lidocaine local anesthesia and receive placebo with no further intervention and with similar procedure of prostate biopsy
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam khomeini hospital of Urmia
Full name of responsible person
Aghamohamadpour Hossein
Street address
Imam khomeini Hosp., Ershad blvd., Homafar 2 ave.
City
Urmia
Province
West Azarbaijan
Postal code
5715781351
Phone
+98 44 3198 8748
Email
aghamohamadpour.h@umsu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Fatemeh Hajmohamadian
Street address
Central Campus of Urmia University of Medical Sciences, Resalat blvd., Jahad Ave.
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 1930
Fax
+98 44 3224 0642
Email
umsu47@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Tayyebi Azar Ali
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Ershad blvd., Imam Khomeini hospital
City
Urmia
Province
West Azarbaijan
Postal code
5715781351
Phone
+98 44 3198 8749
Email
ali.tyazar@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Tayyebi Azar Ali
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Ershad blvd., Imam Khomeini hospital
City
Urmia
Province
West Azarbaijan
Postal code
5715781351
Phone
+98 44 3198 8748
Email
ali.tyazar@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Tayyebi Azar Ali
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Ershad blvd., Imam Khomeini hospital
City
Urmia
Province
West Azarbaijan
Postal code
5715781351
Phone
+98 44 3198 8749
Email
ali.tyazar@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Clinical and demographic findings after personal data deletion.
When the data will become available and for how long
one year after publish
To whom data/document is available
urologist in research or clinical fields
Under which criteria data/document could be used
for repeating of research or experimental use of data
From where data/document is obtainable
urology ward- Imam hospital in Urmia
What processes are involved for a request to access data/document
Direct request from researcher by web based connection