Comparison of the effect of lidocaine ampoule and clove oil on episiotomy pain
Design
A clinical trial with a control group with randomized parallel groups on 33 patients with closed envelopes and 4 blocks of randomization
Settings and conduct
The intervention is that before performing episiotomy on the spot, lidocaine in the control group and clove oil + lidocaine will be used for anesthesia in the intervention group. At the first expression of perineal pain by the patient, the VAS pain intensity scale is used to measure His pain was used and in the lidocaine group, its injectable form (lidocaine 2%) and in the intervention group, clove oil (0.8% made by Barij Essential Oil Factory) was used simultaneously with lidocaine 2% to reduce pain. This oil is applied and rubbed on the episiotomy site 10 minutes before the appropriate time for injection, and after episiotomy in both groups, one hour later, 6 hours and 12 hours later, the pain intensity is measured with VAS scale. .
Participants/Inclusion and exclusion criteria
individuals if they wish and have inclusion criteria, which include: singleton, first-born or second-born pregnancy with an age range of 18 to 35 years, live fetus and gestational age 38 to 42 weeks, no medical problems before and after childbirth, no drug or food allergies Specific, no special problems such as descending disorders, impaired dilatation and effusion, no use of forceps and vacuum for childbirth will be included in the study.
comparison the efficacy of lidocaine ampule and lidocaine ampule with clove oil on episiotomy pain:a randomized clinical trial
Public title
lidocain and clove oils in episiotomy pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Single and primiparous or second pregnancies the age range of 18 to 35 years, live fetus the gestational age 38 to 42 weeks, no medical problems before and after delivery, no specific drug or food allergies, no special problems such as abnormalities, disorder In the development of dilatation and effusion, do not use forceps and vacuum for childbirth
Exclusion criteria:
thwe women who dont need episiatomy such as high quallity of skin and muscle in prineoum
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
33
Randomization (investigator's opinion)
Randomized
Randomization description
This will be done by the blocking method via closed envelopment.. This will be done by the blocking method. For this purpose, 4 blocks are selected in which six possible cases will be considered so that the intervention group will have the letter A and the control group will have the letter B, and 6 sequences (AABB, ABAB, ABBA, BBAA, BABA (BAAB) This sequence is repeated by substitution until the desired sample size is reached. This work (sequence allocation process) will be performed by an external observer (other than the principal investigators). This task (sequence allocation process) will be performed by an external observer (other than the principal investigators).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Common Ethics Committee of the School of Nursing and Midwifery and Rehabilitation
Street address
Tohid square
City
Tehran
Province
Tehran
Postal code
3971713967
Approval date
2019-06-08, 1398/03/18
Ethics committee reference number
IR.TUMS.VCR.REC.1398.286
Health conditions studied
1
Description of health condition studied
THE PAIN IN EPISIATOMY SITE
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
episiotomy pain
Timepoint
Measurements at the beginning of the study (before an episiotomy incision) and during wound healing
Method of measurement
visual pain assessment questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Lidocaine with clove oil Control group: Lidocaine. In the intervention group, in the lidocaine group (control), its injectable form (lidocaine 2%) and in the intervention group, clove oil (0.8% made by Barij Essential Oil Factory) with lidocaine 2%, before episiotomy to reduce pain. Is used. This oil is applied and rubbed on the episiotomy site 10 minutes before the right time to inject lidocaine, and after episiotomy in both groups, one hour later, 6 hours and 12 hours later, the pain intensity is VAS scale. Is taken
Category
Treatment - Drugs
2
Description
Control group: Lidocaine.Control group: lidocaine. In the lidocaine group, its injectable form (lidocaine 2%) is used according to the hospital routine, before episiotomy to reduce pain. This ampoule is made 2-3 minutes before the episiotomy at the injection site and then the episiotomy, and after the episiotomy is performed in both groups again one hour later, 6 hours and 12 hours later, the pain intensity is measured with the VAS scale. Adequacy of anesthesia will be checked by asking the mother before performing the episiotomy
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Baharloo hospital
Full name of responsible person
Elham Ebrahimi
Street address
Rahahan square
City
Tehran
Province
Tehran
Postal code
134512345
Phone
+98 21 6105 4214
Email
Ebrahimi_308@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Elham Ebrahimi
Street address
Tohid square, Nosrat street
City
Tehran
Province
Tehran
Postal code
3971713967
Phone
+98 21 7632 3903
Email
ebrahimi_308@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice chancellor of 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
Elham Ebrahimi
Position
Assistant proff
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Tohid square
City
Tehran
Province
Tehran
Postal code
3971713967
Phone
+98 21 6105 4214
Email
Ebrahimi_308@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Elham Ebrahimi
Position
associated proff
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Tohid square
City
Tehran
Province
Tehran
Postal code
3971713967
Phone
+98 21 6105 4214
Email
Ebrahimi_308@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Elham Ebrahimi
Position
proff
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Tohid square
City
Tehran
Province
Tehran
Postal code
3971713967
Phone
+98 21 6105 4214
Email
ebrahimi_308@yahoo.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
All data is potentially shareable after unidentified individuals
When the data will become available and for how long
after finishing the studiy at july 2021
To whom data/document is available
all of targeted population
Under which criteria data/document could be used
just for knowing about the study results
From where data/document is obtainable
main web page of tehran university of medical sciences
What processes are involved for a request to access data/document