the Effect of intraperitoneal Bupivacaine in comparison with Dexmedetomidine with Bupivacaine Spray on pain reduction after laparoscopic Endometrial Surgery, A Randomized Clinical Trial
the Effect of intraperitoneal Bupivacaine in comparison with Dexmedetomidine with Bupivacaine Spray on pain reduction after laparoscopic Endometrial Surgery, A Randomized Clinical Trial
Design
This randomized clinical trial will be performed on 45 individuals with Endometrioma who will be referred to Rasoul Akram Hospital. The patients are randomly assigned to three groups of 15 people using a random number table with Excel software, a) the treatment group with bupivacaine b) The treatment with bupivacaine with dexmedetomidine c) The group without medication. This study will be performed as a single blind method.
Settings and conduct
This randomized clinical trial will be performed on 45 individuals with Endometrioma who will be referred to Rasoul Akram Hospital. The patients will be randomly assigned to three groups of 15 people. This study will be performed as a single blind method.
Participants/Inclusion and exclusion criteria
inclusion criteria: having informed consent; laparoscopic surgery due to benign gynecologic diseases; age 20 to 65 years old
Exclusion criteria: dissatisfaction, People who use these drugs are harmful to them
Intervention groups
In this study, the intervention was bupivacaine treatment or bupivacaine treatment with doxedmodine and non-medicated group.
Main outcome variables
Pain after surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150817023666N11
Registration date:2018-04-09, 1397/01/20
Registration timing:retrospective
Last update:2018-04-09, 1397/01/20
Update count:0
Registration date
2018-04-09, 1397/01/20
Registrant information
Name
Abolfazl Mehdizadeh kashi
Name of organization / entity
Iran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 216651500
Email address
mehdizadeh.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2017-03-21, 1396/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the Effect of intraperitoneal Bupivacaine in comparison with Dexmedetomidine with Bupivacaine Spray on pain reduction after laparoscopic Endometrial Surgery, A Randomized Clinical Trial
Public title
the Effect of intraperitoneal Bupivacaine in pain reduce
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent to enter the study
Candidate for laparoscopic surgery due to benign gynecological disease
Age between 20 and 65 years
Patients ASA I, II
women with endometriosis
Exclusion criteria:
Patients who have not signed the consent form
Patients whose laparoscopic surgery has changed to vaginal or abdominal
Patients that underwent surgery without general anesthesia
Pregnant women
Allergy to local anesthetics or Dexmedetomidine
Patients with morbid obesity
Patients with liver or kidney failure
Age
From 20 years old to 65 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to three groups of 15 people, using the random numbers table.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants and outcome evaluators will not be informed of random allocation.
For this purpose, before the random allocation, a full explanation of the intervention was given to the patient, Patients will not be informed about random allocation.
The outcome evaluators will not be aware of the allocation of patients to study groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic commite of Iran University of Medical science
Street address
Next to Milad Tower, Hemmat hayway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1445613131
Approval date
2016-09-14, 1395/06/24
Ethics committee reference number
IR.IUMS.rec.1395.27252
Health conditions studied
1
Description of health condition studied
Endometriosis
ICD-10 code
N80.0
ICD-10 code description
Endometriosis of uterus
Primary outcomes
1
Description
Pain
Timepoint
before surgery and 2,4 ,6 ,12 and 24 Hour after surgery
Method of measurement
Visual analog score
Secondary outcomes
empty
Intervention groups
1
Description
First group: intra peritonal bupivacaein spray ( 50 cc 0.25%) this intervention will be performed at the end of the procedure.
Category
Treatment - Drugs
2
Description
second group: intraperitonal bupivacaein( 50 cc .25% )with DEX(1 micro g/kg) spray this intervention will be performed at the end of the procedure
Category
Treatment - Drugs
3
Description
control group: intraperitonal normalsalin spray this intervention will be performed at the end of the procedure.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul-e-Akram Hospital
Full name of responsible person
Abolfazal Mehdizadeh kashi
Street address
Rasool Akram Hospital, Nayesh Avenue, Sattar Khan Avenue, Tehran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2562
Email
amehdizadehkashi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Seyyed Kazem Malekouti
Street address
Iran University Of Medical science, side of milad tower, Hemmat highway, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
PR@iums.ac.ir
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Zahra Najmi
Position
Professor of Obstetrics and Gynecology, Fellowship of minimally invasive gynecology
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Niayesh Av, Sattar khan st, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449613131
Phone
+98 21 6650 9283
Fax
Email
amehdizadehkashi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Abolfazl Mehdizadeh Kashi
Position
Professor of Obstetrics and Gynecology, Fellowship of minimally invasive gynecology
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Niayesh Av. Sattar khan st. Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1449613131
Phone
+98 21 6650 9283
Fax
Email
amehdizadehkashi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Pasture Institute of Iran
Full name of responsible person
Abolfazal Mehdizadeh kashi
Position
Professor of Obstetrics and Gynecology, Fellowship of minimally invasive gynecology
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Niayesh Av. Sattar khan st. Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1449613131
Phone
+98 21 6650 9283
Fax
Email
amehdizadehkashi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Title and more details about the data/document
Total data without personal information
When the data will become available and for how long
after publication of paper
To whom data/document is available
Researchers
Under which criteria data/document could be used
further research
From where data/document is obtainable
Dr.Rokhgireh
s.rokhgireh@gmail.com
What processes are involved for a request to access data/document