Evaluation of the effect of diluted intravesical bupivacaine on the urinary catheter related bladder discomfort during recovery from anesthesia in young males
Bladder discomfort due to urinary catheter is one of the most common reasons of patient’s agitation in the recovery room after operations. This complication especially is more obvious in young male patients. So the importance of this complication and relative short-coming of previous protective and therapeutic modalities, in a prospective randomized double blinded clinical trial we intend to use a diluted local anesthetic drug “Bupivacaine”, infused directly into bladder via urinary catheter, for evaluating whether this drug is able to reduce that complication or not?
In this study we will use 54 male patients with 18-60 years old, witch candidate for non-pelvic surgeries under general anesthesia and need urinary catheterization during his operations. Cases will elected from ASA physical class I & II and selected patients must be without kidney and urinary tract disease, prostate hypertrophy and also overactive bladder symptoms.
After induction of anesthesia, patients will be catheterized with a NO: 16 folly catheter by using 2% lidocaine lubricant gel, and its cuff will inflate with 10 ml of distilled water. Fifteen min before the termination of the surgery, in control group 50 ml of normal saline, and in the intervention group 50 ml of 0.2% bupivacaine will be infused into bladder via urinary catheter and then catheter will clamped for 30 min. After that in the recovery room, patients will be evaluated for occurrence of agitation and intensity of bladder discomfort related to catheter every 15 min until 1 hour by using “Likert Scale”. Also the dose of fentanyl and midazolam used for treatment of these complications will be recorded and compared statistically between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014090111398N6
Registration date:2014-09-23, 1393/07/01
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-09-23, 1393/07/01
Registrant information
Name
Mohammad Reza Ghodraty
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8894 6762
Email address
m-ghodrati@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research deputy of Iran University of Medical Sciences
Expected recruitment start date
2014-10-01, 1393/07/09
Expected recruitment end date
2015-03-31, 1394/01/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of diluted intravesical bupivacaine on the urinary catheter related bladder discomfort during recovery from anesthesia in young males
Public title
Effect of intravesical bupivacaine on the urinary catheter related bladder discomfort
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: male gender, 18-60 years old, candidated for surgery under general anesthesia, having indication for urinary catheter insertion, ASA physical class I & II, and agreement for participation in the study
Exclusion criteria: female gender, age less than 18 and more than 60, no indication for bladder catheterization during surgery, ASA class more than II, no agreement for participation, addiction to opiates and other drugs abusers, patients with kidney and urinary tract diseases and intra pelvic & lower abdomen surgeries.
Age
From 18 years old to 59 years old
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
54
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
Iran University of Medical Sciences
Street address
Hemmat highway, between Sheykhfazlollah and Chamran
City
Tehran
Postal code
Approval date
2014-05-20, 1393/02/30
Ethics committee reference number
24713- 103614
Health conditions studied
1
Description of health condition studied
Urinary catheter related bladder discomfort
ICD-10 code
T19.1
ICD-10 code description
Foreign body in bladder
Primary outcomes
1
Description
Severity of patient's bladder discomfort in recovery
Timepoint
Every 15 min after arrival of patients to recovery until 30 min
Method of measurement
Patient's own report and question from them
2
Description
Severity of patient's agitation
Timepoint
Every 15 min after arrival of patients to recovery until 30 min
Method of measurement
Observation by recovery room nurse
Secondary outcomes
1
Description
Amount of fentanyl usage
Timepoint
Discharge time from recovery
Method of measurement
Sum of the drug usage
Intervention groups
1
Description
In intervention group: Infusion of 50 ml Bupivacaine 0.2% into bladder via urinary catheter 15 min before awakening from anesthesia
Category
Prevention
2
Description
In control group: Infusion of 50 ml normal saline as placebo into bladder via urinary catheter 15 min before awakening from anesthesia
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Firoozgar Hospital
Full name of responsible person
Mohammad Reza Ghodraty
Street address
Anesthesiology department, Firoozgar hospital, Beh-afarin St, Karim Khan Av.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research & tecnology, Iran University of Medical Sciences
Full name of responsible person
Seyed Ali Javad Moosavi MD.
Street address
Department of Internal Medicine, Hazrat-E-Rasoul Hospital, Iran University of Medical Sciences, Niayesh St., Sattarkahn Ave
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research & tecnology, Iran 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
Iran University of Medical Sciences
Full name of responsible person
Mohammad Reza Ghodraty MD.
Position
Anesthesiologist, Assistant professor
Other areas of specialty/work
Street address
Anesthesiology Department, Firoozgar Hospital, Beh-afrin St, Karim Khan Av.
City
Tehran
Postal code
Phone
+98 21 8894 6762
Fax
Email
mrghodrati@yahoo.comghodrati.mr@iums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Reza Ghodraty
Position
Anesthesiologist, Assistant Professor
Other areas of specialty/work
Street address
Anesthesiology Department, Firoozgar Hospital, Beh-afarin St, Karim Khan Av.
City
Tehran
Postal code
Phone
+98 21 8894 6762
Fax
Email
mrghodrati@yahoo.comghodrati.mr@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Mwdical Sciences
Full name of responsible person
Mohammad Reza Ghodraty MD.
Position
Anesthesiologist
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)