Protocol summary

Study aim
General purpose: Determining and comparing the injection of Ketorlak with 2% lidocaine with Ketorlak in the surgical incision site in the intensity of pain after cesarean section
Design
Clinical trial, with parallel group, double-blind, randomized, phase 2 on 34 patients, we used the randomization table for randomization.
Settings and conduct
Pregnant mothers are randomly assigned by a third person outside the study and without knowing the names of the patients in the group receiving ketorolac or the group receiving ketorolac and lidocaine. Then we check the patient's vital signs and hydrate the patient and finally the pregnant mother and is subjected to spinal anesthesia. At the end, after the surgery in the recovery department, and then 6 and 24 days after the surgery in the women's department, and by providing the patients with the vas questionnaire, the information will be collected after the patients answer the questionnaire.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Pregnant women candidates for caesarean section in the age range between 18 and 50 years old through spinal anesthesia with 12.5 mg bupivacaine and needle number 25 Exit criteria: Patients with known mental disorders Patients with diabetes Patients with cardiovascular diseases, gestational diabetes, eclampsia and pre-eclampsia Emergency caesarean section
Intervention groups
The first group includes people who receive ketorolac and lidocaine as well, and the second group includes people who only use ketorolac.
Main outcome variables
Because the caesarean section is a painful procedure, using this study we are looking for a method to effectively reduce the caesarean section pain in pregnant mothers.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240528061936N1
Registration date: 2024-12-03, 1403/09/13
Registration timing: prospective

Last update: 2024-12-03, 1403/09/13
Update count: 0
Registration date
2024-12-03, 1403/09/13
Registrant information
Name
Farzad Alishir
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5525 8841
Email address
farzadalishir@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-12-05, 1403/09/15
Expected recruitment end date
2025-09-22, 1404/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of injection of ketorolac and lidocaine with ketorolac in the surgical incision site in pain intensity after caesarean section
Public title
Comparison of injection of ketorolac and lidocaine with ketorolac in the surgical incision site in pain intensity after caesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
pregnant woman candidate for caesarean section Age range from 18 to 50 years Satisfaction of the expectant mother
Exclusion criteria:
Lack of personal satisfaction Age range above 65 or below 18 A patient with a psychological disorder A patient with diabetes A patient with cardiovascular disease Patients with preeclampsia and eclampsia Emergency caesarean section
Age
From 18 years old to 50 years old
Gender
Female
Phase
2
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 34
Randomization (investigator's opinion)
Randomized
Randomization description
Pregnant mothers will be included in the study in an easy and accessible way according to the entry conditions, and then the pregnant mothers will be randomly assigned to one of the intervention groups. In the future, pregnant mothers will be randomly assigned to one of the intervention groups. The first group includes people who receive ketorolac and lidocaine in addition to it, and the second group includes people who only use ketorolac. The way of randomization will be in such a way that there is an equal number of each group in each block. This problem occurs when the study uses the blocking method with fixed blocks. Blocking is usually used in order to balance the number of samples allocated to each of the studied groups. This feature helps the researchers to have the same number of samples assigned to each of the studied groups in cases where intermediate analyzes are needed during the sampling process.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a double-blind study, in which the researcher and the participant are blinded, in such a way that the mothers are randomly selected by a third person outside the study and without knowing the names of the patients in the group receiving ketorolac and the group receiving ketorolac and Lidocaine is placed.A person who randomizes to enter the study through blocking will not be aware of the names of the patients and will only divide the patients. Only the researcher will know the names of the patients. Then, after collecting the data by the researcher, we will provide the data to a statistical consultant who does not know about the patients for statistical analysis and the data will be analyzed.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Zahedan University of Medical Sciences
Street address
Dr. Hasabi Square, Zahedan University of Medical Sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2024-05-12, 1403/02/23
Ethics committee reference number
IR.ZAUMS.REC.1403.097

Health conditions studied

1

Description of health condition studied
The amount of pain in the caesarean section wound
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pain score based on vas questionnaire
Timepoint
After the operation in the recovery room and 6 and 24 hours after the operation in the obstetrics and gynecology department
Method of measurement
Vas pain questionnaire

Secondary outcomes

1

Description
Complications of drugs based on Iowa Questionnaire
Timepoint
In the obstetrics and gynecology department after surgery
Method of measurement
Based on the iowa questionnaire

Intervention groups

1

Description
Injection of Ktorlak drug, half a milligram per kilogram of a person's weight from Alborz Daru pharmaceutical company, at the incision site of cesarean surgery.
Category
Treatment - Drugs

2

Description
Intervention group: Ketorlak drug, half a milligram per kilogram of body weight from Alborz Daru Pharmaceutical Company and 2% lidocaine, one milligram per kilogram of body weight from Aburihan Pharmaceutical Company at the incision site of cesarean surgery.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ali ebn Abitaleb hospital
Full name of responsible person
Farzad Alishir
Street address
Ali ebn Abitaleb,in front of Imam Khomeini Mosque,Persian Gulf Highway
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
۹۸۱۶۷۴۳۱۱۱
Phone
+98 54 3329 5570
Fax
+98 54 1341 1252
Email
hospital.aliebneabitaleb@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Ibrahim Kord
Street address
First Block on the Right (Block 1) Room 312,Kikha Muslim Brothers Dormitory,Medical Sciences Campus,Dr. Hasabi Square,Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 902 502 7878
Email
farzadalishir@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
Proportion provided by this source
1
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
Zahedan University of Medical Sciences
Full name of responsible person
Farzad Alishir
Position
Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
First Block on the Right (Block 1) Room 312,Kikha Muslim Brothers Dormitory,Medical Sciences Campus,Dr. Hasabi Square,Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 902 502 7878
Email
Farzadalishir@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Farzad Alishir
Position
Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
First Block on the Right (Block 1) Room 312,Kikha Muslim Brothers Dormitory,Medical Sciences Campus,Dr. Hasabi Square,Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 902 502 7878
Email
farzadalishir@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Farzad Alishir
Position
Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
First Block on the Right (Block 1) Room 312,Kikha Muslim Brothers Dormitory,Medical Sciences Campus,Dr. Hasabi Square,Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 902 502 7878
Email
farzadalishir@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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