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Comparison of the effectiveness of subcutaneous Ketamine and subcutaneous Dexamethasone on postoperative pain after surgery in women undergoing elective cesarean section.​

Protocol summary

Study aim
The aim of this study is to investigate the impact of subcutaneous ketamine versus subcutaneous dexamethasone on pain following elective cesarean
Design
This study will include 93 candidates for elective cesarean surgery who meet the inclusion criteria. The candidates will be randomly divided into three groups, each consisting of 31 people, using block division.
Settings and conduct
In the first intervention group, 0.5 mg of diluted ketamine weight will be injected subcutaneously at the caesarean incision site while closing the skin, and in the second intervention group, 16 mg of dexamethasone will be injected subcutaneously in the same way. The control group will not receive any additional intervention. Pain intensity will be recorded at 0 , 2, 6, 12, and 24 hours after surgery based on the visual pain scale. This study was conducted in Ayatollah Mousavi Hospital, Zanjan, in a double-blind manner, and the data collector and the analyst will not know about the patient group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: ASA class 1 or 2 Age between 18-45 years Single term pregnancy Candidate for non-emergency cesarean surgery Insensitivity to ketamine and dexamethasone No history of chronic pain, neurological and mental diseases, cardiovascular diseases Not receiving any kind of pain medication in the last 24 hours
Intervention groups
In the first intervention group, 0.5 mg of diluted ketamine will be injected subcutaneously at the cesarean incision site at the end of the surgery while closing the skin. In the second intervention group, 16 mg of dexamethasone will be injected subcutaneously in the same way at the cesarean incision site. The third group, or control group, will not receive any additional intervention.
Main outcome variables
The time of requesting the first dose of painkillers, the amount and frequency of painkillers in the first 24 hours after surgery

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200421047160N3
Registration date: 2024-05-31, 1403/03/11
Registration timing: registered_while_recruiting

Last update: 2024-05-31, 1403/03/11
Update count: 0
Registration date
2024-05-31, 1403/03/11
Registrant information
Name
Azadeh Hosseinkhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3336 2447
Email address
azihsnkhani@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-19, 1402/12/29
Expected recruitment end date
2024-07-19, 1403/04/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of subcutaneous Ketamine and subcutaneous Dexamethasone on postoperative pain after surgery in women undergoing elective cesarean section.​
Public title
The effect of subcutaneous Ketamine and Dexamethasone on pain intensity after caesarean section
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
ASA class 1 or 2 Single term pregnancy Candidate for non-emergency cesarean surgery Insensitivity to ketamine and dexamethasone There is no history of chronic pain, neurological or mental diseases, or cardiovascular diseases. The patient has not received any pain medication in the last 24 hours.
Exclusion criteria:
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 93
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, block randomization will be used to allocate samples to intervention groups. In this method, blocks of 3 sizes are created, then so many blocks are selected to reach the required sample size in each group. Finally, 31 blocks of 3 will be created.
Blinding (investigator's opinion)
Double blinded
Blinding description
The outcome assessor, who is a member of another department's staff, is unaware of the type of medication the patient received. Also, the statistical analyzer is not aware of the type of medicine received by the patient and all the samples have a code.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Street address
Professor Dr. Youssef Sobuti Blvd., Zanjan University of Medical Sciences
City
Zanjan
Province
Zanjan
Postal code
4513956184
Approval date
2024-01-05, 1402/10/15
Ethics committee reference number
IR.ZUMS.REC.1402.233

Health conditions studied

1

Description of health condition studied
Pain intensity after elective caesarean section
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
pain intensity
Timepoint
0 (recovery), 2, 6, 12 and 24 hours after cesarean section
Method of measurement
Visual Analogue Scale

Secondary outcomes

1

Description
Time to request the first pain reliever
Timepoint
Within 24 hours after cesarean section
Method of measurement
Patient's verbal request

Intervention groups

1

Description
The first intervention group: Subcutaneous ketamine 0.5 mg per kg
Category
Treatment - Drugs

2

Description
The second intervention group: Subcutaneous dexamethasone 16 mg
Category
Treatment - Drugs

3

Description
Control group: It does not receive any intervention.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Mousavi Zanjan Hospital
Full name of responsible person
Zahra Mansouri
Street address
Blvd. Prof. Sobouti, Ayatollah Mousavi Hospital
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3313 0000
Email
info@zums.ac.ir
Web page address
https://mousavi.zums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Vice President of Research and Technology, Zanjan University of Medical Sciences
Street address
Professor Dr. Youssef Sobouti Boulevard, Zanjan University of Medical Sciences
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3301 8041
Email
info@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Azadeh Hosseinkhani
Position
instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Ansarieh St., 14 Valiasr St., Golestan, No. 1055, Unit 1
City
Zanjan
Province
Zanjan
Postal code
4515765831
Phone
009824333362447
Email
azihsnkhani@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Azadeh Hosseinkhani
Position
istructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Ansarieh, Valiasr Street, 14 Golestan Alley, No. 1055, Unit 1
City
Zanjan
Province
Zanjan
Postal code
4515765831
Phone
+98 24 3333 4261
Email
azihsnkhani@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Azadeh Hosseinkhani
Position
instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Ansarieh, Valiasr Street, 14 Golestan Alley, No. 1055, Unit 1
City
Zanjan
Province
Zanjan
Postal code
4515765831
Phone
+98 24 3336 2447
Email
azihsnkhani@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
No - There is not 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
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
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