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Investigating the effect of the patient's Trendelenburg position along with high volume ventilation and placement of long gas in the abdominal cavity on shoulder tip pain after cesarean section

Protocol summary

Study aim
Determining the effect of the patient's Trendelenburg position along with high volume ventilation and placement of long gas in the abdominal cavity on the occurrence of shoulder tip pain after cesarean section.
Design
A controlled, parallel-group, randomized, phase 2 clinical trial on 100 patients. The randomization method is a simple randomization method. The unit of randomization is individual.
Settings and conduct
This study will be conducted in Imam Reza Hospital of Mashhad and includes patients referred for cesarean section. In the intervention group, in the case of spinal anesthesia, the patients will be placed in the Trendelenburg position and long gauze will be placed on both sides of the uterus. In the control group, in the case of spinal anesthesia, they will be placed in a flat and horizontal position. Then, in both groups, 24 hours later, shoulder pain will be measured with VAS scoring criteria.No blinding was done. ​
Participants/Inclusion and exclusion criteria
The study inclusion criteria include all patients who are candidates for elective cesarean section. Exclusion criteria include patients not agreeing to participate in the study or causing any surgical or obstetric complications during cesarean surgery for the mother and baby.
Intervention groups
In the intervention group, in the case of spinal anesthesia, the patients will be placed in the Trendelenburg position, and long gauze will be placed on both sides of the uterus, and in the case of general anesthesia, ventilation with a higher volume will be used. became. In the control group, in the case of spinal anesthesia, they will be placed in a flat and horizontal position, and in the case of general anesthesia, they will receive medium-volume ventilation.
Main outcome variables
Shoulder pain after caesarean section

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231025059861N1
Registration date: 2023-11-18, 1402/08/27
Registration timing: prospective

Last update: 2023-11-18, 1402/08/27
Update count: 0
Registration date
2023-11-18, 1402/08/27
Registrant information
Name
Alireza Mortazavipasand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3711 2585
Email address
mortazavipasanda991@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-21, 1402/08/30
Expected recruitment end date
2024-06-20, 1403/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of the patient's Trendelenburg position along with high volume ventilation and placement of long gas in the abdominal cavity on shoulder tip pain after cesarean section
Public title
Investigating Trendelenburg position and high volume ventilation on shoulder pain after cesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Elective caesarean section candidates obtaining informed consent
Exclusion criteria:
Presence of chronic shoulder or upper limb pain History of any fracture in the shoulder joints
Age
From 15 years old to 50 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 170
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is a simple randomization method. The unit of randomization is individual. Using the table of random numbers, patients are randomly divided into two groups: The experimental group and the control group. Even numbers are considered for the experimental group and odd numbers are for the control group. Random allocation is done by the researcher .
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
No. 66, 24 Ave.motahhari Blvd
City
mashhad
Province
Razavi Khorasan
Postal code
7135574133
Approval date
2023-02-05, 1401/11/16
Ethics committee reference number
IR.MUMS.IRH.REC.1401.065

Health conditions studied

1

Description of health condition studied
Shoulder pain in caesarean section patients
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Shoulder pain after caesarean section
Timepoint
24 hours after patients leave the recovery room and enter the ward
Method of measurement
The pain intensity will be measured based on the visual pain criterion

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: including the patient's Trendelenburg position during cesarean section and with high volume ventilation and placement of long gas in the abdominal cavity
Category
Treatment - Devices

2

Description
Control group: Patients who were not placed in the Trendelenburg position during cesarean section and are in a flat position.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Seyed Alireza Mortazavipasand
Street address
Ebne Sina St
City
mashhad
Province
Razavi Khorasan
Postal code
91379133169
Phone
+98 51 3854 3031
Email
mortazavipasandA991@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
vcresraech@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Seyed Alireza Mortazavipasand
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No. 66, 24 Ave.motahhari Blvd
City
mashhad
Province
Razavi Khorasan
Postal code
7135574133
Phone
+98 51 3711 2585
Email
mortazavipasanda991@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyed Alireza Mortazavipasand
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No. 66, 24 Ave.motahhari Blvd
City
mashhad
Province
Razavi Khorasan
Postal code
7135574133
Phone
+98 51 3854 3031
Email
mortazavipasanda991@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyed Alireza Mortazavipasand
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No. 66, 24 Ave.motahhari Blvd
City
mashhad
Province
Razavi Khorasan
Postal code
7135574133
Phone
+98 51 3854 3031
Email
mortazavipasanda991@mums.ac.ir

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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