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The effect of prostatic regional block on post-operative urethral catheter discomfort in transurethral prostatectomy surgery

Protocol summary

Study aim
The effect of prostatic regional block on post-operative urethral catheter discomfort in transurethral prostatectomy surgery
Design
Randomized double-blind randomized clinical trial with trial phase 2-3
Settings and conduct
Intervention group: Patients in the first group will received 0.5 mg / kg bupivacaine during one minute for periprostatic block by transrectal method at the end of the surgery. Control group: Patients will not received with 0.5 mg / kg bupivacaine during one minute for periprostatic block by transrectal method at the end of the surgery. The surgeon and the person preparing the medicine and providing it to the surgeon were aware of the type of study; While the patient, the patient evaluator in the recovery room and the statistical analyst were unaware of the type of study and block performed.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:50-70 years, ASA one and two, patients undergoing prostate surgery, patients under general anesthesia. Exclusion Criteria: Uncontrolled underlying disease, history of chronic pelvic pain, opium addicts, anxiety disorders, restlessness, time and space loss, confusion, tremor, chills, seizures, tinnitus, bradycardia, decreased cardiac function, hypotension, Cardiovascular collapse, respiratory arrest, nausea and vomiting, cases in which the surgeon decides to perform open prostatectomy for any reason, including active bleeding, history of discopathy, history of coagulopathy.
Intervention groups
Intervention group: Patients in the first group will received 0.5 mg / kg bupivacaine during one minute for periprostatic block by transrectal method at the end of the surgery. Control group: Patients will not received with 0.5 mg / kg bupivacaine during one minute for periprostatic block by transrectal method at the end of the surgery.
Main outcome variables
Pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20141009019470N108
Registration date: 2021-02-06, 1399/11/18
Registration timing: prospective

Last update: 2021-02-06, 1399/11/18
Update count: 0
Registration date
2021-02-06, 1399/11/18
Registrant information
Name
Farzaneh Masihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4270
Email address
masihif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-20, 1399/12/02
Expected recruitment end date
2021-03-24, 1400/01/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of prostatic regional block on post-operative urethral catheter discomfort in transurethral prostatectomy surgery
Public title
The effect of prostatic regional block on post-operative urethral catheter discomfort in transurethral prostatectomy surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
50-70 years ASA one and two patients undergoing prostate surgery patients under general anesthesia
Exclusion criteria:
Uncontrolled underlying disease History of chronic pelvic pain Opium addicts Anxiety disorders Restlessness Time and space loss Confusion Tremor Shivering Seizures, tinnitus Bradycardia Decreased cardiac function Hypotension Cardiovascular collapse Respiratory arrest Nausea and vomiting Cases in which the surgeon decides to perform open prostatectomy for any reason, including active bleeding History of discopathy History of coagulopathy
Age
From 50 years old to 70 years old
Gender
Male
Phase
2-3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 42
Randomization (investigator's opinion)
Randomized
Randomization description
Using a random table taken from sealedenvelped.com and 4 and 6 permutation blocks patients are divided into two groups .Patients were placed in the intervention or control group upon entering the operating room.
Blinding (investigator's opinion)
Double blinded
Blinding description
The surgeon and the person preparing the medicine and providing it to the surgeon were aware of the type of study; While the patient, the patient evaluator in the recovery room and the statistical analyst were unaware of the type of study and block performed.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Vice Chancellor of research, Shiraz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Approval date
2016-06-17, 1395/03/28
Ethics committee reference number
IR .SUMS.MED.REC.1395.71

Health conditions studied

1

Description of health condition studied
Benign prostatic hyperplasia
ICD-10 code
D29.1
ICD-10 code description
Benign neoplasm of prostate

Primary outcomes

1

Description
post-operative urethral catheter discomfort
Timepoint
At the beginning of the recovery and then 30, 60, 90 and 120 minutes later and at the time of transfer to the ward
Method of measurement
During the two hours of patients' stay in recovery, the amount of pain and discomfort caused by the urethral catheter is divided into three degrees: Zero: Do not feel discomfort caused by the catheter. One: Patients feel mild discomfort after the question but do not complain on their own. Two: Patients without question express a feeling of urination, discomfort in the suprapubic or burning urination. Three: Feeling uncomfortable with unquestioning behaviors such as kicking the bed, yelling at the nurse, trying to remove the urethral catheter.

2

Description
Morphine consumption in recovery
Timepoint
Time of discharge from recovery
Method of measurement
observation

Secondary outcomes

1

Description
Blood pressure
Timepoint
During the operation and after the operation until the transfer to the recovery and in recovery every 15 minutes.
Method of measurement
Monitoring

2

Description
Recovery Stay
Timepoint
Duration of presence in recovery
Method of measurement
When Aldrete score time reaches 6

Intervention groups

1

Description
Intervention group: Patients in the first group will received with 0.5 mg / kg bupivacaine during one minute for periprostatic block by transrectal method at the end of the surgery.
Category
Prevention

2

Description
Control group: Patients will not received with 0.5 mg / kg bupivacaine during one minute for periprostatic block by transrectal method at the end of the surgery.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Faghihi Hospital
Full name of responsible person
Fatane Jamshidi
Street address
Namazi Hospital, Namazi Square
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
fatanejamshidi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Abbas Rezaieanzadeh
Street address
Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
vcrd@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Fatane Jamshidi
Position
Anesthesiology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
fatanejamshidi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ali Karami
Position
Cardio-anesthesiologist
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
alk1380@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Masihi
Position
BS in anesthesia/English Consultant
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
5th floor, Mohammad Rasoul Allah Research Tower, Khalili Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
masihifarzaneh@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Its against our policies.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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