Investigating the effect of intraperitoneal injection of ondansetron during elective caesarean section on postoperative pain intensity in pregnant mothers undergoing the first repeated caesarean section In kamali hospital: A clinical trial study
Determining the effect of intraperitoneal injection of ondansetron during surgery on reducing pain after cesarean section
Design
Two arm parallel group randomised trial with 30 pregnant women in each group, randomized with computer-generated table of random numbers.
Settings and conduct
This study will be conducted in Kamali Hospital on pregnant women candidates for caesarean section. Patients who have signed informed consent to participate in the project will be randomly assigned to two groups.in the first group Ondansetron 8 mg ampoule with 12 cc of normal saline is poured into the abdominal cavity before closing the peritoneum. , and in the second group 20cc of normal saline is poured into the abdominal cavity before closing the peritoneum. Then (0, 0.5, 1, 1.5, 3, 6) hours after the surgery, the pain scre is determined using a visual scale and compared between the two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: candidate for cesarean delivery due to a previous cesarean section Having a history of cesarean delivery healthy fetus ASA II Age between 20-40 years gestational age of term.
Exclusion criteria: Having an underlying disease, Emergency cesarean section, History of ondansetron allergy, Receiving painkillers or sedatives 24 hours before surgery.
Intervention groups
Control group: 20cc of normal saline is poured intraperitoneally into the abdominal cavity before closing the peritoneum.
Intervention group: Ondansetron 8 mg ampoule with 16 cc of normal saline is poured intraperitoneally into the abdominal cavity before closing the peritoneum.
Main outcome variables
The pain score after cesarean delivery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220610055121N1
Registration date:2022-09-12, 1401/06/21
Registration timing:prospective
Last update:2022-09-12, 1401/06/21
Update count:0
Registration date
2022-09-12, 1401/06/21
Registrant information
Name
Ferdos Zamani Khalili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3253 9067
Email address
f.zamani3130@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-22, 1401/07/30
Expected recruitment end date
2022-11-22, 1401/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of intraperitoneal injection of ondansetron during elective caesarean section on postoperative pain intensity in pregnant mothers undergoing the first repeated caesarean section In kamali hospital: A clinical trial study
Public title
Evaluating the effect of intraperitoneal injection of ondansetron during elective caesarean section on postoperative pain intensity after caesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
A candidate for cesarean delivery due to a previous cesarean section
Having a history of cesarean delivery
healthy fetus
ASA II
Age between 20-40 years
gestational age of term
Exclusion criteria:
Having an underlying disease
Emergency cesarean section
History of ondansetron allergy
Receiving painkillers or sedatives 24 hours before surgery
Age
From 20 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Group assignment is determined from a computer-generated table of random numbers.Some opaque envelopes are used for concealment.
Blinding (investigator's opinion)
Double blinded
Blinding description
Completion of the final information is up to the person who is unaware of the type of treatment and also the patients and the specialist will be blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Alborz University of Medical Sciences (Research Ethics Committee)
Street address
Taleghani Square, North Taleghani Boulevard, Administrative Town, Alborz University of Medical Sciences
City
Karaj
Province
Alborz
Postal code
3149779453
Approval date
2022-08-13, 1401/05/22
Ethics committee reference number
IR.ABZUMS.REC.1401.122
Health conditions studied
1
Description of health condition studied
Examining the pain level of pregnant mothers after cesarean section
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
pain score
Timepoint
0, 0.5, 1, 1.5, 3, 6 hours after the surgery
Method of measurement
Visual analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Ondansetron 8 mg ampoule (Exir,Iran) with 16 cc of normal saline (Total 20 cc) is poured intraperitoneally into the abdominal cavity before closing the peritoneum.
Category
Treatment - Drugs
2
Description
Control group: 20cc of normal saline is poured intraperitoneally into the abdominal cavity before closing the peritoneum.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Kamali Hospital
Full name of responsible person
Ferdos Zamani Khalili
Street address
Shahid Beheshti St., Shohada Square, Kamali St.
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3222 3021
Email
Kamali@abzums.ac.ir
Web page address
https://abzums.ac.ir/en-US/kamali.abzums.ac
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Hatem Godini
Street address
Karaj-Golshahr-Safarian Street-Department of Research and Technology of Alborz University of Medical Sciences
City
Karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3452 9133
Email
research@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj 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
Karaj University of Medical Sciences
Full name of responsible person
Ferdos Zamani Khalili
Position
General medicine student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Kamali Medical Education Center, Kamali St., Shahada Square, Karaj
City
Karaj
Province
Alborz
Postal code
3134877179
Phone
+98 26 3226 6851
Email
f.zamani3130@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Dr. Masoumeh Farahani
Position
Gynecology and obstetrics specialist, academic staff
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kamali Medical Education Center, Shahada Square, Karaj
City
Karaj
Province
Alborz
Postal code
3134877179
Phone
+98 26 3226 6851
Email
Kamali@abzums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Ferdos Zamani Khalili
Position
General medicine student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Kamali Medical Education Center, Kamali St., Shahada Square, Karaj
City
Karaj
Province
Alborz
Postal code
3134877179
Phone
+98 26 3226 6851
Email
f.zamani3130@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