Clinical evaluation the effect of Xylapi ointment and lidocaine spray on the patient's satisfaction, stress, cooperation and pain level in spinal anesthesia for cesarean section and comparing it with the control group
Raise awareness about reducing pain and increasing maternal satisfaction when using Xylapi ointment compared to Lidocaine spray in Cesarean Section of pregnant mothers.
Design
A parallel-group, single-blind, randomized controlled clinical trial involving 258 patients. They are placed in 3 groups in the form of block randomization and quadruple block.
Settings and conduct
This study will be conducted in Bharlo hospital in order to compare the level of cooperation, satisfaction, pain and anxiety of pregnant mothers over 37 weeks and candidates for caesarean section. In this study, one-way blinding was done for the patients and the patients were placed in three groups of 86 people, in the intervention group 1 of 10 grams of Xylapi ointment at the needle entry site and in the intervention group 2 of 3 puffs of 10% lidocaine spray at the entry site. A needle is used to create anesthesia, and in the control group, 3 puffs of distilled water are used, and the results will be compared between the 3 groups based on the visual pain scale and scoring by the anesthesiologist with the cooperation of the mothers.
Participants/Inclusion and exclusion criteria
Entry criteria: Pregnant women with a gestational age of over 37 weeks who are candidates for elective cesarean section.
Exclusion criteria: gestational age below 37 weeks ؛ candidates for emergency cesarean section ؛ chronic diseases of blood pressure and diabetes ؛ allergy to lidocaine ؛ addiction ؛ contraindications for spinal anesthesia.
Intervention groups
In intervention group 1, 10 grams of Xylapi ointment is used at the needle entry site, and in intervention group 2, 3 puffs of 10% lidocaine spray are used at the needle entry site to create anesthesia. 3 puffs of distilled water are also used in the control group.
Clinical evaluation the effect of Xylapi ointment and lidocaine spray on the patient's satisfaction, stress, cooperation and pain level in spinal anesthesia for cesarean section and comparing it with the control group
Public title
Clinical evaluation the effect of Xylapi ointment and lidocaine spray on the patient's satisfaction, stress, cooperation and pain level in spinal anesthesia for cesarean section and comparing it with the control group
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women referred to Bharlo Hospital with a gestational age of more than 37 weeks who are candidates for elective cesarean section
Exclusion criteria:
Gestational age below 37 weeks
Pregnant women who are candidates for emergency cesarean section
Pregnant women with chronic hypertension and diabetes
History of allergy to lidocaine
History of addiction and contraindications for spinal anesthesia
Age
From 15 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
258
Randomization (investigator's opinion)
Randomized
Randomization description
We divide the patients into 3 groups by block randomization and quadruple block, totaling 86 people, which include 258 people and have a gestational age of more than 37 weeks. In the intervention group 1, which consists of 86 people, 10 grams of Xylapi ointment is used in a cross-sectional area of 10 square centimeters (according to the anesthesiologist's opinion) 20 to 30 minutes before the spinal injection in the place where the needle is inserted to create anesthesia. In the intervention group 2 as well 3 puffs of 10% lidocaine spray are used at the needle insertion site 5-10 minutes before the spinal. In the control group, 3 puffs of distilled water are used 10 minutes before the spinal.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the subjects are aware that a new method is being studied and researched, but they are blinded to which group they belong to and which drug is being studied on them.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees Of School Of Medicine Tehran University of Medical Sciences
Street address
Research and Technology Affairs Management Unit, Room 604, 6th Floor, Headquarters of Tehran University of Medical Sciences, Corner of Qods St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2023-01-23, 1401/11/03
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1401.702
Health conditions studied
1
Description of health condition studied
caesarean section
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The amount of mother's pain during spinal needle insertion
Timepoint
After caesarean section
Method of measurement
Visual Analog Scale
2
Description
The level of mother's satisfaction during transfer to the ward (end of recovery)
Timepoint
After caesarean section
Method of measurement
Visual Analog Scale
3
Description
The level of mother's anxiety before the insertion of the spinal needle
Timepoint
After caesarean section
Method of measurement
Visual Analog Scale
4
Description
The level of cooperation of the mother according to the anesthesiologist
Timepoint
After caesarean section
Method of measurement
Anesthesiologist grading from 1 to 10
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group 1, which consists of 86 people, 10 grams of Xylapi ointment is used in a cross-sectional area of 10 square centimeters (according to the opinion of an anesthesiologist) 20 to 30 minutes before the spinal injection at the place where the needle is inserted to create anesthesia. Then it is patched. The preb and lid are done and the mother is put under spinal anesthesia with a G25 needle and half percent marcaine ampoule.
Category
Treatment - Drugs
2
Description
In intervention group 2, 3 puffs of 10% lidocaine spray are used at the needle insertion site 5-10 minutes before the spinal injection.
Category
Treatment - Drugs
3
Description
In the control group, 3 puffs of distilled water are used 10 minutes before spinal.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Baharlou hospital
Full name of responsible person
Zahra Ghale Noii
Street address
Behdari St., Rah Ahan Sq.
City
Tehran
Province
Tehran
Postal code
1339973111
Phone
+98 21 5565 8500
Email
baharloo@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Ghale Noei
Street address
Pour Sina St., District 6, Tehran Province
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8889 6696
Email
tumspr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Zahra Ghale Noie
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Behdari St., Rah Ahan Sq.
City
Tehran
Province
Tehran
Postal code
1339973111
Phone
+98 21 5565 8500
Email
zgh.5068@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Ghale Noie
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Behdari St., Rah Ahan Sq.
City
Tehran
Province
Tehran
Postal code
1339973111
Phone
+98 21 5565 8500
Email
zgh.5068@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Ghale Noie
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Behdari St., Rah Ahan Sq.
City
Tehran
Province
Tehran
Postal code
1339973111
Phone
+98 21 5565 8500
Email
zgh.5068@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
Yes - There is 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
This study aims to compare the effect of Xylapi ointment with lidocaine spray on reducing pain and anxiety during spinal surgery for cesarean section, and after collecting all the information related to the topics under study, it will be given to the researchers.
When the data will become available and for how long
After completing the data collection and writing the thesis in 1403
To whom data/document is available
Specialists in obstetrics and gynecology and anesthesia
Under which criteria data/document could be used
Persons who have access to the information by writing a letter to the research unit of Tehran University of Medical Sciences and the holder of the code of ethics and the IRCT code by referring to the research assistant of Baharlu Hospital.
From where data/document is obtainable
Research Unit of Tehran University of Medical Sciences, Research Vice-Chancellor of Baharlu Hospital
What processes are involved for a request to access data/document
Writing a letter with the research unit of Tehran University of Medical Sciences and receiving the code of ethics and referring to the research unit of Baharlo Hospital and receiving information