Preventive effect of adding morphine to topical lidocaine in the case group compared with normal saline increase to topical lidocaine and intravenous morphine in the control group on pain intensity after mastoidectomy-tympanoplasty
The study of the preventive effect of adding Morphin to local lidocaine2% on the pain intensity after mastoidectomy-tympanoplasty surgery and its comparison with control group
Design
80 patients were divided into two groups of 40 patients (lidocaine with morphine) and control (lidocaine) in a randomized block. A parallel and single-phase study was conducted to evaluate the preventive effect of adding morphine to lidocaine on patients undergoing elective mastoidectomy-tympanoplasty.
Settings and conduct
Patient's history was recorded by the researcher through a pre-surgical check-up checklist in the recovery department of Isfahan's Al-Zahra Hospital. The patient did not know the therapeutic content of the pain reduction method. Data was also provided to the data analyst without any personal information or type of therapy group.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Patients aged between 15-65 years old and have no underlying disease or at least an underlying controled disease. Patients undergoing mastoidectomy-tympanoplasty surgery have no history of drug and alcohol addiction, seizure and mental problems, and kidney disease.
Exclusion criteria:Prolonged operation for more than 2.5 hours, the possibility of a patient's phallopathy until the end of the intervention for various reasons such as death.
Intervention groups
In the intervention group, 0.15 mg / kg of morphine was added to 100 mg of lidocaine 2% and epinephrine 1: 200000, and in the control group, the same volume of normal saline was added to lidocaine and epinephrine and injected at the surgical site and the patient was 0.15 milligram per kilogram of morphine are given intravenously.
Main outcome variables
Severity of postoperative pain and hemodynamic changes during and after mastoidectomy-tympanoplasty
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171230038142N3
Registration date:2018-12-04, 1397/09/13
Registration timing:retrospective
Last update:2018-12-04, 1397/09/13
Update count:0
Registration date
2018-12-04, 1397/09/13
Registrant information
Name
Khosro Tavakol
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 9134
Email address
tavakol@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2018-02-19, 1396/11/30
Actual recruitment start date
2016-05-21, 1395/03/01
Actual recruitment end date
2018-03-11, 1396/12/20
Trial completion date
2018-03-11, 1396/12/20
Scientific title
Preventive effect of adding morphine to topical lidocaine in the case group compared with normal saline increase to topical lidocaine and intravenous morphine in the control group on pain intensity after mastoidectomy-tympanoplasty
Public title
The study of the preventive effect of adding Morphin to local lidocaine2% on the pain intensity after mastoidectomy-tympanoplasty surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 15-65 years
No underlying disease or at least have controled underlying disease.
Patients undergoing mastoidectomy-tympanoplasty surgery
Exclusion criteria:
No history of drug and alcohol addiction
No history of seizures and mental problems
Lack of kidney disease
Age
From 15 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
80
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were divided into intervention and control groups using block randomisation and 40 patients were assigned to each group. Thus, considering two blocks of forty, 20 patients were treated with lidocaine and 20 patients using lidocaine and morphine.
Blinding (investigator's opinion)
Double blinded
Blinding description
After assigning patients to two groups of intervention and control, the patient's history was recorded by the researcher through the pre-surgery checklist in recovery and in the department. The patient did not know the therapeutic content of the pain reduction method. Data was also provided to the data analyst without any personal information or type of therapy group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences & Health Services, Hezarjarib Ave.
City
Esfahan
Province
Isfehan
Postal code
81747-73461
Approval date
2017-05-21, 1396/02/31
Ethics committee reference number
IR.MUI.REC.1396.3.077
Health conditions studied
1
Description of health condition studied
Severity of pain after mastoidectomy-tympanoplasty
ICD-10 code
Z09.0
ICD-10 code description
Follow-up examination after surgery for other conditions
Primary outcomes
1
Description
pain intensity
Timepoint
Measurement of pain intensity at pre-induction, after induction and during surgery was measured.
Method of measurement
Using the pain scale and the patient's questioning
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group was treated with topical lidocaine 2% and epinephrine by adding 15.0 mg / kg of morphine to one hundred milligrams.
Category
Prevention
2
Description
Control group: One hundred mg of local lidocaine 2% and epinephrine were surgically treated with 0.15 mg / kg of intravenous morphine. This was followed by surgery with localized lidocaine and intravenous morphine with normal saline increase.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital in Isfahan
Full name of responsible person
Khalili Gholam Reza
Street address
Al-Zahra Hospital, Sofah Boulevard.
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
khalili@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Khalili Gholam Reza
Street address
Isfahan University of Medical Sciences & Health Services, Hezarjarib Ave.
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
khalili@med.mui.ac.ir
Grant name
Deputy of Research of Isfahan University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Khalili Gholam Reza
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Al-Zahra Hospital, Sofah Boulevard.
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
khalili@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Khalili Gholam Reza
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Al-Zahra Hospital, Sofah Boulevard.
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
khalili@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Khalili Gholam Reza
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Al-Zahra Hospital, Sofah Boulevard.
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
khalili@med.mui.ac.ir
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
Yes - There is 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
Data can be shared after the patient is not identified and after obtaining permission from the research vice president and after publication of the article.
When the data will become available and for how long
Two years after printing, it is possible to access the data with the permission of the research vice president.
To whom data/document is available
All researchers in the medical group, especially the anesthetic group.
Under which criteria data/document could be used
To extend the results or compare the results of another study with the present study, with the consent of the researcher and the Isfahan University of Medical Sciences, the results and documentation can be used.
From where data/document is obtainable
To receive the documentation after obtaining permission from the Research and Student Vice-Dean of the Isfahan University of Medical Sciences, e-mail khalili@med.mui.ac.ir.
What processes are involved for a request to access data/document
After obtaining permission from the Research and Student Vice-Chancellor of the Isfahan University of Medical Sciences, please send an e-mail to khalili@med.mui.ac.ir, clearly.