Studying the effect of Tamsulosin on postoperative urinary retention in patients undergoing Inguinal hernia repair under spinal anesthesia at IMam sajjad hospital in 2022
All subjects were NPO (nil per os) about 8 hours before the surgery, and during this time, they were given 1 liter of 1/3 2/3 intravenous fluids. They were asked to empty their bladder prior to surgery. All participants went under spinal anesthesia with 2 cc of Marcaine. During the surgery they all received 1 liter of normal saline 0.9% intravenously. The following 4-6 hours after surgery, they were maintained NPO and received another 1 liter of 1/3 2/3.
Following surgery, all subjects were closely monitored for 24 hours by the responsible nurse and the surgeon in case of developing POUR. Urinary retention was diagnosed if the subject was unable to urinate in the presence of palpable bladder in 24 hours postoperatively, so foley catheterization was performed to relieve patient’s discomfort.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age older than 50 years old; unilateral inguinal hernia; being candidate for spinal anesthesia.
Exclusion criteria: orthostatic hypotension; strangulated hernia; need for other surgery at the same time.
Intervention groups
Enrolled participants are randomly assigned into two groups. Group A ( 50 subjects) received 0.4 mg Tamsulosin 8 hours prior to operation, group B (50 subjects) received placebo a gelatinous capsule containing lactose in similar shape and appearance as Tamsulosin 8 hours prior to operation.
Main outcome variables
Postoperative urinary retention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220131053898N1
Registration date:2022-02-15, 1400/11/26
Registration timing:prospective
Last update:2022-02-15, 1400/11/26
Update count:0
Registration date
2022-02-15, 1400/11/26
Registrant information
Name
Seyedeh-Atefe Seyedin Navadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 912 287 7480
Email address
atefe.seyedin98@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-19, 1400/11/30
Expected recruitment end date
2022-06-10, 1401/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the effect of Tamsulosin on postoperative urinary retention in patients undergoing Inguinal hernia repair under spinal anesthesia at IMam sajjad hospital in 2022
Public title
Studying the effect of Tamsulosin on postoperative urinary retention in patients undergoing inguinal hernia repair under spinal anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age older than 50 years old
Unilateral inguinal hernia
Candidate for spinal anesthesia
Exclusion criteria:
Bilateral hernia
Strangulated hernia
General anesthesia
Prostate cancer
BPH
Orthostatic hypotention
Concurrent surgery
Age
From 50 years old
Gender
Male
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, block randomization will be used to generate a random sequence. The size of the blocks is selected randomly (blocks of 6 and 4). Each block contains an equal number of each group. Random sequence generation software will be used to generate random sequences. To hide random allocation, opaque envelopes sealed with random sequences will be used. Each random sequence is recorded on a card, and the cards are placed in the envelopes of the order, respectively. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. At the beginning of the registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes of the letter is opened and the assigned group of the participant is revealed.
Blinding (investigator's opinion)
Double blinded
Blinding description
Enrolled patients and the responsible nurse for providing the medications are unaware of the type of medicine used for their case.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mazandaran University of Medical Sciences
Street address
Vali Asr blvd., Jouybar tree way, Imam square
City
Sari
Province
Mazandaran
Postal code
4815733971
Approval date
2022-03-01, 1400/12/10
Ethics committee reference number
IR.MAZUMS.RIB.REC.1400.031
Health conditions studied
1
Description of health condition studied
Post inguinal hernioplasty urinary retention
ICD-10 code
K40.9
ICD-10 code description
Unilateral inguinal hernia, without obstruction or gangrene
Primary outcomes
1
Description
Post operative urinary retention
Timepoint
In the next 24 hours after surgery
Method of measurement
Ability to urinate
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: patients inguinal hernia is confirmed by physical examination or sonography. All patients are kept NPO(nil per os ) 8 hours before the surgery and they receive 1 liter of dextrose saline solution . They receive tamsulosin 0.4 mg from Abidi company 8 hours before the surgery and 6,12 hours after the surgery .
Category
Prevention
2
Description
Control group: patients inguinal hernia is confirmed by physical examination or sonography. All patients are kept NPO(nil per os ) 8 hours before the surgery and they receive 1 liter of dextrose saline solution . They receive a gelatinous capsule containing glucose 8 hours before the surgery and 6,12 hours after the surgery .
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Sajjad Hospital
Full name of responsible person
Seyedeh Atefe Seyedin Navadeh
Street address
Enghelab square. Motahhari blvd.
City
ramsar
Province
Mazandaran
Postal code
4691714143
Phone
+98 11 5522 0810
Email
imamsajjadhospitalramsar@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Seyedeh-Atefe Seyedinnavadeh
Street address
Vali Asr blvd., Jouybar three way
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 912 287 7480
Email
atefe.seyedin98@yahoo.com
Web page address
Grant name
Mazandaran university of medical sciences, research and technology division
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Mohammad Hadizadeh Neisanghalb
Position
assistance professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Vali Asr blvd., Jouybar three way
City
Sari
Province
Mazandaran
Postal code
4691710001
Phone
+98 11 5509 1101
Email
h.of.mohammad@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mohammad Hadizadeh Neisanghalb
Position
Assistance professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Vali Asr blvd., Jouybar three way, Imam square
City
Sari
Province
Mazandaran
Postal code
4691710001
Phone
+98 11 5509 1101
Email
h.of.mohammad@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mohammad Hadizadeh Neisanghalb
Position
Assistance professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Vali asr blv, jouybar three way, Imam square
City
Sari
Province
Mazandaran
Postal code
4691710001
Phone
+98 11 5509 1101
Email
h.of.mohammad@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Specific part of data except personal name and ID would be shared with other researchers in future
When the data will become available and for how long
We can share our data after publishing an article
To whom data/document is available
Researchers from other universities
Under which criteria data/document could be used
They can use it only if they mention the names of the researchers of this study
From where data/document is obtainable
email
What processes are involved for a request to access data/document