Objectives: To evaluate the effect of intracapsular bupivacaine injection in post open prostatectomy pain control
Design: Randomized, Double blind, Placebo controlled, single center
Setting and conduct: 38 patients aged from 55 to 100 years old with good general condition who referred for obstructive urinary symptoms due to benign prostatic hyperplasia and having the indication for open prostatectomy, after being aware of the study and filling the informed consent will enter the study.
Inclusion criteria: Patients who are candidate for open prostatectomy due to obstructive urinary symptom and do not have allergy to bupivacaine
Exclusion criteria: Prostatic capsule perforation during the surgery
Intervention: Open prostatectomy will be performed in both groups. In the intervention group after removing the prostatic adenoma, 20 ml of 0.5% bupivacaine will be injected in the posterior prostatic capsule from 4 to 8 o clock. In the control group 20 ml of normal saline will be injected in the before mentioned area.
Main outcome measures: Amount of analgesic used and visual analog scale of pain
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015061822168N2
Registration date:2015-12-21, 1394/09/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-12-21, 1394/09/30
Registrant information
Name
Dinyar Khazaeli
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3221 0695
Email address
khazaeli-d@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Jundishapur University of Medical Sciences
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2015-09-23, 1394/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To evaluate the effect of intracapsular bupivacaine injection in post open prostatectomy pain control
Public title
Decreasing pain in prostate surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients who are candidate for open prostatectomy due to obstructive urinary symptom and do not have allergy to bupivacaine
Exclusion criteria: Prostatic capsule perforation during the surgery
Age
From 55 years old to 100 years old
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
38
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
ground floor, Ahvaz Jundishapur University of Medical Sciences, Golestan BLvd.
City
Ahvaz
Postal code
61357-15794
Approval date
2015-05-30, 1394/03/09
Ethics committee reference number
IR.AJUMS.REC.1394.39
Health conditions studied
1
Description of health condition studied
Benign prostatic hyperplasia
ICD-10 code
N40
ICD-10 code description
Hyperplasia of prostate
Primary outcomes
1
Description
The amount of pethidine used
Timepoint
Every our in the first 8 hours from the surgery and then every 3 hours therafter up to 24 hours
Method of measurement
The amount of used drug in miligram
2
Description
Amount of pain
Timepoint
Every our in the first 8 hours from the surgery and then every 3 hours therafter up to 24 hours
Method of measurement
Based on pain visual analog scale which is filled by the patient from 0 to 10
Secondary outcomes
1
Description
Side effects
Timepoint
24 hours after the surgery
Method of measurement
Any changes in blood pressure and cardiac arrhythmias
Intervention groups
1
Description
In the intervention group after removing the prostatic adenoma, 20 ml of 0.5% bupivacaine will be injected in the posterior prostatic capsule from 4 to 8 o clock.
Category
Prevention
2
Description
In the control group after removing the prostatic adenoma, 20 ml of normal saline will be injected in the posterior prostatic capsule from 4 to 8 o clock.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Dr. Dinyar Khazaeli
Street address
Azadegan Avenue
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Jundishapur University of Medical Sciences
Full name of responsible person
Nader Saki
Street address
Office of Vice-chancellor of research and technology, ground floor, Jundishapur University of Medical Sciences, Golestan BLvd.
City
Ahvaz
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, Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Dinyar Khazaeli
Position
Fellowship of uro-oncology, Assistant Professor of Urology, Research Vice-Chancellor of Imam Khomein