Compare the effect of intrarectal lidocaine gel and lidocaine gel in combination with fentanyl in pain reduction during in patients undergoing prostate biopsy: a clinical trial
Objectives: Compare the intrarectal administration of lidocaine gel with lidocaine gel -fentanyl in pain reduction of prostate biopsy. Study groups: Patients candidate for prostate biopsy. Sample size: 96 patients. Randomization: a table of random number. Blinding: double blind. Control group will be administered 50 gr lidocaine gel 2% and the intervention group will receive 50 µgr intrarectal fentanyl in combination with 50 gr lidocaine gel (2%). Prostate biopsy will be performed after 30 minutes in both groups. Primary outcome: pain intensity based on VAS criteria. Secondary outcomes: Blood pressure, pulse rate and level of consciousness which will be measured and documented by another researcher.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201612013773N17
Registration date:2017-01-22, 1395/11/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-01-22, 1395/11/03
Registrant information
Name
Farsad Imani
Name of organization / entity
Tehran University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 21 4469 0816
Email address
imanifar@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the effect of intrarectal lidocaine gel and lidocaine gel in combination with fentanyl in pain reduction during in patients undergoing prostate biopsy: a clinical trial
Public title
A method of pain reduction during prostate biopsy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients candidate for prostate biopsy; Minimum weight 40 kg
Exclusion criteria: uncontrolled blood pressure; sensitivity to local anesthetics; advanced heart, renal or hepatic disease; opioid addiction.
Age
From 30 years old to 80 years old
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
At the begining of Ghods St, Keshavars Blvd
City
Tehran
Postal code
9111174011-140764
Approval date
2016-06-14, 1395/03/25
Ethics committee reference number
IR-TUMS.REC.1395-2678
Health conditions studied
1
Description of health condition studied
Dysplasia of prostate
ICD-10 code
N42.3
ICD-10 code description
Dysplasia of Prostate, Low grade dysplasia
Primary outcomes
1
Description
Pain
Timepoint
Before and During Biopsy
Method of measurement
VAS Score
2
Description
Blood Pressure
Timepoint
Before and During Biopsy
Method of measurement
Monitoring
3
Description
Heart Rate
Timepoint
Before and During Biopsy
Method of measurement
Pulse Oximetry
Secondary outcomes
1
Description
Level of consciousness
Timepoint
Before and during biopsy
Method of measurement
Miller Score
Intervention groups
1
Description
Intervention Group: intrarectal administration of 50 gr lidocaine gel (2%) produced by Sina daro company and 50 mcg fentanyl produced by Rasht-Iran company.
Category
Treatment - Drugs
2
Description
Control Group: intrarectal administration of 50 gr lidocaine gel 2% prodused by Sina daro company.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr. Tayeb Gavili
Street address
Sina Hospital, Hasan Abad Square, Imam Khomeini Avenue
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Tehran University of Medical Sciences
Full name of responsible person
Masoud Yunesian
Street address
6th Floor, Central building of University, Adjacent Ghods St. Boulevard Keshavarz
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Farsad Imani
Position
Anesthesiologist/Associate Professor
Other areas of specialty/work
Street address
Sina Hospital, Hasan Abad Square, Imam Khomeini Avenue
City
Tehran
Postal code
1136746911
Phone
+98 21 4469 0816
Fax
+98 21 6634 8555
Email
imanifar@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Tayeb Gavili
Position
Assistant of Anesthesiology
Other areas of specialty/work
Street address
Sina Hospital, Hasan Abad Square, Imam Khomeini Avenue
City
Tehran
Postal code
1136746911
Phone
+98 21 6312 0000
Fax
+98 21 6634 8553
Email
tayebgavli@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Dr.Tayeb Gavili
Position
Assistant of Anesthesiology
Other areas of specialty/work
Street address
Sina Hospital, Hasan Abad Square, Imam Khomeini Avenue
City
Tehran
Postal code
1136746911
Phone
+98 21 6312 0000
Fax
+98 21 6634 8553
Email
tayebgavli@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)