Investigation of the effect of the intraoperative dose of intravenous dexamethasone on post-cesarean delivery analgesia in pregnant mothers referred to Kosar Educational and Medical Hospital in Qazvin 1399
The effect of intraoperative intravenous dexamethasone on post-cesarean delivery analgesia in pregnant women
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 88 patients. The method of assigning participants will be simple randomization and using the table of random numbers.
Inclusion criteria:
Gestational age>=37 weeks; Age over 18 years and no history of specific disease; Uncomplicated pregnancy; Elective C-section (breech, meconium, macrosome, repeat 2); Absence of previous laparotomy incision except C-section
Exclusion criteria:
contraindications to spinal anesthesia; allergy to study medications; uncontrolled hypertension; uncontrolled DM; glaucoma; IV drug abuse; chronic pain or long-term opioid use; steroid medication within the week prior to cesarean delivery; subjects with psychiatric illness that would prohibit informed consent or comprehension of the study questions; repeat 3 C-section or more than 2 laparotomies; chorioamnionitis; Intra-abdominal adhesions
Intervention groups
Dexamethasone injection to pregnant mothers; Placebo injection to pregnant mothers
Main outcome variables
Pain after cesarean section
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210110049996N1
Registration date:2021-03-05, 1399/12/15
Registration timing:prospective
Last update:2021-03-05, 1399/12/15
Update count:0
Registration date
2021-03-05, 1399/12/15
Registrant information
Name
Seyedeh Firouzeh Aghanejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3335 6620
Email address
f.aghanejad@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-06, 1399/12/16
Expected recruitment end date
2021-09-21, 1400/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of the intraoperative dose of intravenous dexamethasone on post-cesarean delivery analgesia in pregnant mothers referred to Kosar Educational and Medical Hospital in Qazvin 1399
Public title
The effect of dexamethasone on reducing pain after cesarean section in pregnant women referred to Kosar Hospital in Qazvin 1399
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age> = 37 weeks
Age over 18 years and no history of specific disease
Uncomplicated pregnancy
Elective cesarean section (breech, meconium, macrosome, ripit 2)
Absence of previous laparotomy incision except cesarean section
Exclusion criteria:
contraindications to spinal anesthesia
allergy to study medications
uncontrolled hypertension
uncontrolled diabetes mellitus
glaucoma
IV drug abuse
, chronic pain or long-term opioid use
steroid medication within the week prior to cesarean delivery
subjects with psychiatric illness that would prohibit informed consent or comprehension of the study questions
repeat 3 cesarean section or more than two laparotomies
chorioamnionitis
Intra-abdominal adhesions
Age
From 18 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
The method of allocation randomization will be Simple Randomization and using a table of random numbers. So that with equal allocation of 1: 1 ratio, they will be in one of the two groups.
To select a personal sample from a table of random numbers, start surprisingly from a table point in the direction of the levels or columns. Selecting a point can be done by closing your eyes and placing your finger or the tip of a Roman pen on the table. Moving in the direction of the row or column is symbolically different. But according to the type of code (two digits) in the direction of the row or column, the same number of digits should be selected. After this, the route numbers are controlled. There will be two types of numbers, one of which is smaller than the additional number of the study population and the other is larger than the number of the population. You just have to choose the numbers. The selected number is in fact the individual code of the sample community that is selected as the sample of the selected group. This work is going on so long that the number of sample people in Group A can be 44. After completing the sample size, the experimental sample work is completed. And the selected numbers are in group B. In this way, the number of people is usually equal and randomly divided into two groups of 44 people.
Blinding (investigator's opinion)
Double blinded
Blinding description
Group assignments will be concealed in opaque sequentially-numbered envelops. After obtaining informed written consent before the operation, the anesthesiologist who will be a part of the research team will open the group assignment. The anesthetist will prescribe the drugs in the same serum as the "study drug."
Researcher and patients will not be aware of the drug or placebo injection (Two groups blinded).
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Street address
Kowsar hospital, Kowsar Ave, Next to the Electricity Office, Taleqani Ave, Qazvin
City
Qazvin
Province
Qazvin
Postal code
3415613176
Approval date
2020-09-30, 1399/07/09
Ethics committee reference number
IR.QUMS.REC.1399.245
Health conditions studied
1
Description of health condition studied
The effect of intravenous dexamethasone injection on pain after cesarean section
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The effect of intravenous dexamethasone on pain after cesarean section
Timepoint
6,12,18,24 hour after surgery
Method of measurement
Both baseline preoperative and postoperative pain scores at rest and movement will be assessed using a numerical rating scale (NRS) ( 0 means “no pain” and 10 means “the worst possible pain”). Pain at rest will be assessed with the patient lying supine and pain with movement will be assessed when moving from the supine to an upright sitting position.
2
Description
Nausea
Timepoint
6,12,18,24 hour after surgery
Method of measurement
Patients will be asked to rate the severity of postoperative nausea using an 11-point numerical rating scale (NRS) from 0 to 10 (0: “no nausea” to 10: “worst nausea possible”). The number of vomiting episodes, if any during the 24-h study period, will be documented.
3
Description
Pruritus
Timepoint
6,12,18,24 hour after surgery
Method of measurement
Pruritus will be assessed using an 11-point NRS (0: “no pruritus” to 10: “worst pruritus possible”).
Secondary outcomes
1
Description
headache
Timepoint
6,12,18,24 hour after surgery
Method of measurement
Patients will be asked to rate the severity of postoperative headache using an 11-point numerical rating scale (NRS) from 0 to 10 (0: “no headache” to 10: “worst headache possible”). The number of headache episodes, if any during the 24-h study period, will be documented.
Intervention groups
1
Description
Control group: Patients in the intervention group will receive IV dexamethasone 8 mg (2 mL) after clamping the umbilical cord.
Category
Treatment - Drugs
2
Description
Control group: After clamping the umbilical cord, patients in the control group will receive IV normal saline 2 mL.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar hospital
Full name of responsible person
Seyedeh Firouzeh Aghanejad
Street address
Kowsar hospital, Kowsar Ave, Next to the Electricity Office, Taleqani Ave, Qazvin
City
Qazvin
Province
Qazvin
Postal code
3415613176
Phone
+98 28 3323 6374
Email
f.aghanejad@qums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Peyman Namdar
Street address
Kowsar Hospital, Kowsar Ave, Next to the Electricity Office, Taleqani Ave, Qazvin
City
Qazvin
Province
Qazvin
Postal code
3415613176
Phone
+98 28 3323 6374
Email
f.aghanejad@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Seyedeh Firouzeh Aghanejad
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kowsar Hospital, Kowsar Ave, Next to the Electricity Office, Taleqani Ave, Qazvin
City
Qazvin
Province
Qazvin
Postal code
3415613176
Phone
+98 28 3323 6374
Email
f.aghanejad@qums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Seyedeh Firouzeh Aghanejad
Position
residency
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kowsar Hospital, Kowsar Ave, Next to the Electricity Office, Taleqani Ave, Qazvin
City
Qazvin
Province
Qazvin
Postal code
3415613176
Phone
+98 28 3323 6374
Email
f.aghanejad@qums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Seyedeh Firouzeh Aghanejad
Position
residency
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kowsar hospital, Kowsar Ave, Next to the Electricity Office, Taleqani Ave, Qazvin
City
Qazvin
Province
Qazvin
Postal code
3415613176
Phone
+98 28 3323 6374
Email
f.aghanejad@qums.ac.ir
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
Information on pain relief, analgesia, nausea and vomiting, pruritus, headache, and infection at the incision site after dexamethasone injection is shared without specifying the patient personal information.
When the data will become available and for how long
2022 march
To whom data/document is available
It will be available only to researchers working in academic and scientific institutions