The aim of this study was to evaluate shoulder pain after changing Trendelenberg position or head position with angle of 30 degrees at the time of peritoneum.
Design
The present study is a simple-blind, randomized, double-blind, placebo-controlled study with 35 patients in each group and phase 3.
Settings and conduct
The present study is a double-blind study in which patients and statistical analysts are not informed about the type of intervention.
Participants/Inclusion and exclusion criteria
All mothers who are candidates for elective cesarean section in term pregnancy have the following conditions, including non-urgent maternal and fetal reasons. Pregnancy between 42-37 weeks and no spinal indications such as spinal cord infection. In maintaining the proper position .. Existence of neurological and neurological disorders. Maternal dissatisfaction with performing spinal. Coagulation abnormalities
Intervention groups
In the intervention group, the Trendelenberg position or downward shift of 30 degrees at the time of peritoneal closure.
Main outcome variables
shoulder pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190826044617N1
Registration date:2019-09-16, 1398/06/25
Registration timing:registered_while_recruiting
Last update:2019-09-16, 1398/06/25
Update count:0
Registration date
2019-09-16, 1398/06/25
Registrant information
Name
Parya Parvin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3852 5209
Email address
parvinp951@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-17, 1398/01/28
Expected recruitment end date
2020-04-16, 1399/01/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of changing the position on shoulder pain after cesarean section under spinal anesthesia
Public title
The effect of changing the position on shoulder pain after cesarean section under spinal anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All mothers were candidates for elective cesarean section at term pregnancy
Gestational age between 37-42 weeks
Exclusion criteria:
Spin Indicator counter
Sensitivity to local anesthetic drugs
Maternal inability to maintain proper position
Presence of neurological disorders
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
Data analyser
Sample size
Target sample size:
35
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization is simple and the randomization unit is individualized, the position of patients is placed in a sealed envelops and we assign one envelope to each patient.
Blinding (investigator's opinion)
Single blinded
Blinding description
Data was sent in form of two Group ( A and B ) to the person responsible for data analysis and analyzer wasn't not aware of the intervention.
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