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The effect of adding B vitamins to diclofenac on the pain after cesarean section

Protocol summary

Summary
A randomized, single blinded clinical trial with the aim of determining the effect of adding vitamins B to diclofenac on postoperative pain after elective cesarean section 110 from eligible pregnant women undergoing elective cesarean section surgery in Ayatola Taleghani Hospital in Ilam in 1396 Done. In this study, sampling was done first in an unpredictable way, then the units were randomly assigned to diclofenac and diclofenac + B group vitamins. . Inclusion criteria: age 18-35, single-pregnancy, lack of history of high blood pressure, no previous underlying disease, such as heart disease, liver, kidney and seizure, mass index <30 and weight more than 50 kg. Exclusion criteria: placenta previa, placenta abruption, poly hyderamenyaos, need for opiate in recovery, longer surgery, and more general anesthesia. In both groups, the severity of the pain was first measured after surgery and entering the department with the onset of pain, then diclofenac in the group (1) and diclofenac and norobion injected intramuscularly in group (2). Then, the severity of pain and complications after surgery, such as nausea, vomiting, dizziness and ... are recorded at 1, 2, 4, 6, 8, and 12 hours. Diclofenac and pethidine levels are recorded in both groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201711126790N7
Registration date: 2017-11-20, 1396/08/29
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-11-20, 1396/08/29
Registrant information
Name
Zainab Suhrabi
Name of organization / entity
Ilam University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 84 1222 7123
Email address
suhrabi-z@medilam.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research and Technology of Ilam University of Medical Sciences
Expected recruitment start date
2017-11-16, 1396/08/25
Expected recruitment end date
2018-01-15, 1396/10/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of adding B vitamins to diclofenac on the pain after cesarean section
Public title
The effect of adding B vitamins to diclofenac on the cesarean pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age 18-35, single-pregnancy, lack of history of high blood pressure, no previous disease, such as heart disease, liver, kidney and seizure, mass index <30 and weight more than 50 kg. . Exclusion criteria: placenta previa, placenta abruption, poly hyderamenyaos, need for opiate in recovery, longer surgery, and more general anesthesia
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 110
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ilam University of Medical Sciences Ethics committee
Street address
Ilam University of Medical Sciences
City
Ilam-Banganjab
Postal code
6939177143
Approval date
2017-05-10, 1396/02/20
Ethics committee reference number
ir.medilam.rec.1396.18

Health conditions studied

1

Description of health condition studied
postoperative pain after cesarean section
ICD-10 code
082-9
ICD-10 code description
Delivery by caesarean section, unspecified

Primary outcomes

1

Description
severity of pain
Timepoint
1, 2, 4, 6, 8, and 12 hours after cesarian
Method of measurement
VAS

Secondary outcomes

1

Description
complications after surgery
Timepoint
1, 2, 4, 6, 8, and 12 hours after cesarian
Method of measurement
questionnaire

Intervention groups

1

Description
In the control group, diclofenac injections are injected intramuscularly.
Category
Treatment - Drugs

2

Description
In the intervention group, diclofenac and neurobion are injected intramuscularly
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatola Taleghani Hospital
Full name of responsible person
zainab suhrabi
Street address
Ilam beside to Iran Khodro
City
Ilam

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Kalvandi - Deputy of Research and Technology of the University
Street address
Banganjab - Deputy of Research and Technology University
City
Ilam
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ilam University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
zainab suhrabi
Position
Master of Midwifery Education / Midwifery Manager
Other areas of specialty/work
Street address
Banganjab- pajohesh Blvd- Faculty of Nursing and Midwifery
City
I;am
Postal code
00988412227123
Phone
+98 84 3222 7123
Fax
Email
suhrabi-z@medilam.ac.ir ; suhrabi2007@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
zainab suhrabi
Position
Master of Midwifery Education
Other areas of specialty/work
Street address
Banganjab- pajohesh Blvd- Faculty of Nursing and Midwifery
City
ilam
Postal code
00988412227123
Phone
+98 84 3222 7123
Fax
Email
suhrabi-z@medilam.ac.ir ; suhrabi2007@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
zainab suhrabi
Position
Master of Midwifery / Midwifery Manager
Other areas of specialty/work
Street address
ترجمه ایلام- بانگنجاب- بلوار پژوهش- دانشکده پرستاری و مامایی 54/5000 Elam-Bangajab- pajohesh Blvd- Faculty of Nursing and Midwifery
City
Ilam
Postal code
00988412227123
Phone
+98 84 3222 7123
Fax
Email
suhrabi-z@medilam.ac.ir ; suhrabi2007@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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