The aim of this study was to determine the effect of drainage on the Hemovac drain and deep breathing technique on the amount of shoulder pain in female patients undergoing laparoscopic surgery.
Design
The clinical trial included three groups: two intervention groups and one control group, each with a sample size of 33, community based and pragmatic, with parallel, blind, randomized groups
Settings and conduct
The aim of this study was to determine the effect of using drann in women's laparoscopic surgery on postoperative pain and its comparison with deep breathing technique. This study is a randomized, non-controlled clinical trial. Inclusion criteria include: Diagnostic laparoscopy, myomectomy and cystectomy. In the drain group, laparoscopic surgery is performed routinely. Then a hemovaccum duct with a closed system is embedded in the subtrophic site and is removed from the drainage section before discharge. In the deep breathing group, the person is asked to slowly breathe deeply after three hours of laparoscopic surgery every hour. In a non-drainage group, only laparoscopic surgery is performed routinely. The severity of abdominal pain and shoulder is measured at 3, 6, 12 and 24 hours after visual acuity. After surgery, Diclofenac Suppository is prescribed every 12 hours in case of pain and then the pain and dosage of suppository and surgical complications are compared in three groups.
Participants/Inclusion and exclusion criteria
Entry criteria for non-use of analgesic drugs and lack of surgical history ؛ Exit criteria have had shoulder, abdomen, pelvic before surgery
Intervention groups
Control group 1 the effect of drainage with Hemovac drain on shoulder pain . Control group 2 the effect deep breathing on shoulder pain after laparoscopic surgery in women.Third control group without any intervention.
Main outcome variables
Score of shoulder pain ؛ pain in surgical site
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190113042347N1
Registration date:2019-03-16, 1397/12/25
Registration timing:retrospective
Last update:2019-03-16, 1397/12/25
Update count:0
Registration date
2019-03-16, 1397/12/25
Registrant information
Name
Fatemeh Hosseinzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3382 6629
Email address
fatemeh.hosseinzadeh4780@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-01, 1397/12/10
Expected recruitment end date
2019-09-01, 1398/06/10
Actual recruitment start date
2018-04-30, 1397/02/10
Actual recruitment end date
2018-12-22, 1397/10/01
Trial completion date
2019-01-30, 1397/11/10
Scientific title
The effect of drain hemovac on shoulder pain after women laparoscopic surgery and compared with deep breathing technique
Public title
The effect of drain hemovac on shoulder pain after women laparoscopic surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Complete consciousness
No use of pain medication
Hemodynamic stability
The first surgery under general anesthesia
Exclusion criteria:
Taking memory medication
Having shoulder, abdomen, pelvic pain before surgery
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
99
Actual sample size reached:
99
Randomization (investigator's opinion)
Randomized
Randomization description
To determine the groups, the Block Randomization method is used to determine the groups in the six-block blocks and then determine the situation randomly to determine the final volume of the samples .
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants in the research do not know which investigation groups are located.
Health care personnel do not know which patients are in investigation groups are located.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Farah Abad Road,Sari , Mandarin Province
City
sari
Province
Mazandaran
Postal code
48157-33971
Approval date
2019-02-05, 1397/11/16
Ethics committee reference number
IR.MAZUMS.REC.1397.300
Health conditions studied
1
Description of health condition studied
shoulder pain
ICD-10 code
M25.51
ICD-10 code description
Pain in shoulder
2
Description of health condition studied
Abdominal pain
ICD-10 code
R10.8
ICD-10 code description
Other abdominal pain
Primary outcomes
1
Description
Shoulder pain
Timepoint
At 3, 6, 12, 24 hours after the end of laparoscopic surgery
Method of measurement
Visual Analogue Scale
2
Description
Abdominal pain
Timepoint
At 3, 6, 12, 24 hours after the end of laparoscopic surgery
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Taking analgesic drugs
Timepoint
end of surgery
Method of measurement
check list
2
Description
Nausea
Timepoint
End of surgery
Method of measurement
check list
Intervention groups
1
Description
Intervention group 1: In the drain group, laparoscopic surgery is performed routinely. A hemovaccum duct is then inserted with a closed system from the truce subunit and leaves the morning of the next laparoscopy.
Category
Prevention
2
Description
Intervention group 2 : In the deep breathing group, laparoscopic surgery is performed routinely. After the surgery, the patient breathes deeply up to three times a day.
Category
Prevention
3
Description
Control group: Only laparoscopic surgery is done routinely.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Motahari Hospital, Urmia
Full name of responsible person
Fatemeh Hosseinzadeh
Street address
Shahid Motahari Hospital, Kashani St , Urmia , West Azerbaijan Province
City
Urmia
Province
West Azarbaijan
Postal code
57147-37793
Phone
+98 44 3223 7077
Email
fatemeh20204194@gmail.com
Web page address
https://motahari.umsu.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saeidi
Street address
Central headquarters of Mazandaran University of Medical Sciences and Health Services , Beginning of Valiasr highway, Sari
City
sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3448 4800
Fax
+98 11 3336 2370
Email
ebrahimesmaeili@yahoo.com
Web page address
http://pajooheshi.mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari 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
Mazandaran University of Medical Sciences
Full name of responsible person
Fatemeh Hosseinzadeh
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Operation Room
Street address
No.208 , Alley 14 , hashte shahrivar , Urmia
City
Urmia
Province
Mazandaran
Postal code
57168-37793
Phone
+98 44 3382 6629
Email
fatemeh.hosseinzadeh4780@gmail.com
Web page address
http://www.mazums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ebrahim Nasiri
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Central headquarters of Mazandaran University of Medical Sciences and Health Services , Beginning of Valiasr highway, Sari
City
Sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3354 3247
Fax
Email
rezanf2002@yahoo.com
Web page address
http://paramed.mazums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Fatemeh Hosseinzadeh
Position
MSc Student
Latest degree
Bachelor
Other areas of specialty/work
Operation Room
Street address
No.208, Alley 14, Hashteshahrivar ,Urmia
City
Urmia
Province
West Azarbaijan
Postal code
57168-37793
Phone
+98 44 3382 6629
Email
fatemeh.hosseinzadeh4780@gmail.com
Web page address
http://www.mazums.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