Evaluation of the relationship between co2 insufflation rate during laparoscopic surgery and the shoulder pain after it, in patients undergoing laparoscopic cholecystectomy
Objective: Evaluation of relation between co2 blowing speed during laparoscopy surgery and shoulder pain after surgery in patients with laparoscopic cholecystectomy in Kowsar hospital
Study design: systematic random (toss); without placebo control; single central.
The study population: patients with gallstone that will be undergoing laparoscopic cholecystectomy surgery.
Inclusion criteria: all patients with gallstone that will be undergoing laparoscopic cholecystectomy surgery.
Exclusion criteria: drug addiction; patients who receive sedation exception with shoulder pain; patients who need drains after surgery; patients who associated with bile leakage or bleeding during surgery; patients who have laparoscopic surgery become to open surgery.
Sample size, intervention, intervention time, outcome of study: 100 patients with gallstones referred to operating room in Kowsar hospital that are candidate for laparoscopic cholecystectomy surgery and will be undergoing to surgery.
Intervention group: in this group of 50 peoples, patients will be undergoing laparoscopic cholecystectomy surgery and then co2 gas injection will perform from start of laparoscopic surgery with high-speed (7.5 liters per minute) for them.
Control group: in this group of 50 patients are undergoing laparoscopic cholecystectomy surgery and co2 gas injection will perform from start of laparoscopic surgery with low-speed (2.5 liters per minute) for them.
The number of sedation request in 24 hours after surgery and also shoulder pain in 1, 6, 12 and 24 hours after surgery was checked with verbal rating scale method.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017060125732N17
Registration date:2017-06-18, 1396/03/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-18, 1396/03/28
Registrant information
Name
Alireza Emadi
Name of organization / entity
Semnan University of Medical Sciences, Semnan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 1336
Email address
are20935@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Semnan University of Medical Sciences
Expected recruitment start date
2017-01-03, 1395/10/14
Expected recruitment end date
2018-01-04, 1396/10/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the relationship between co2 insufflation rate during laparoscopic surgery and the shoulder pain after it, in patients undergoing laparoscopic cholecystectomy
Public title
Evaluation of the relationship between co2 insufflation rate during laparoscopic surgery and the shoulder pain after it, in patients undergoing laparoscopic cholecystectomy
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: all patients with gallstone that will be undergoing laparoscopic cholecystectomy surgery.
Exclusion criteria: drug addiction; patients who receive sedation exception with shoulder pain; patients who need drains after surgery; patients who associated with bile leakage or bleeding during surgery; patients who have laparoscopic surgery become to open surgery.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
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, Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Postal code
3514799442
Approval date
2017-01-03, 1395/10/14
Ethics committee reference number
IR.SEMUMS.REC.1395.158
Health conditions studied
1
Description of health condition studied
Shoulder pain
ICD-10 code
M25.5
ICD-10 code description
Pain in joint
Primary outcomes
1
Description
Shoulder pain intensity
Timepoint
1, 6, 12 and 24 hours after surgery.
Method of measurement
verbal rating scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: in this group of 50 peoples, patients will be undergoing laparoscopic cholecystectomy surgery and then co2 gas injection will perform from start of laparoscopic surgery with high-speed (7.5 liters per minute) for them.
Category
Diagnosis
2
Description
Control group: in this group of 50 peoples, patients are undergoing laparoscopic cholecystectomy surgery and co2 gas injection will perform from start of laparoscopic surgery with low-speed (2.5 liters per minute) for them.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar Hospital
Full name of responsible person
Setareh Soltany
Street address
Kosar Hospital, Street Amin, Semnan
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences, Deputy of Research and Technology
Full name of responsible person
Mohammadreza Asgari
Street address
Semnan University of Medical Sciences, Deputy of Research and Technology, Basij Blvd, Semnan
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences, Deputy of Research and Technology
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
Semnan University of Medical Sciences
Full name of responsible person
Setareh Soltany
Position
General surgery
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, Blvd Basij, Semnan
City
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
+98 23 3344 8999
Email
are20935@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Setareh Soltany
Position
General surgery
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, Blvd Basij, Semnan
City
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
+98 23 3344 8999
Email
are20935@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Setareh Soltany
Position
General surgery
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, Blvd Basij, Semnan
City
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
+98 23 3344 8999
Email
are20935@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)