Comparison of the effect of standard gas pressure with low intra-abdominal co2 pressure on postoperative shoulder pain in laparoscopic cholecystectomy patients
Determining the effect of standard pressure with low intra-abdominal co2 pressure on postoperative shoulder pain in laparoscopic cholecystectomy patients.
Design
A triple blind clinical trial with a control group, with parallel groups, phase 3 of 34 patients.Allocation of samples to intervention and control groups is done non-randomly
Settings and conduct
This study is conducted in patients with symptomatic gallstones who refer to Qazvin Velayat hospital and are candidates for laparoscopic cholecystectomy according to the order of the patient's surgeon. the patient enters one of 2 groups A (standard intra-abdominal co2 pressure), group B (low intra-abdominal co2 pressure). Participant and outcome assessor and data safety and monitoring committee are blinded
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients aged 25 to 70 who have symptomatic gallstones or chronic cholecystitis.
Exclusion criteria:
pregnant women
Age < 25 years and > 70 years
Gallbladder carcinoma and its abnormalities
Previous upper abdominal surgery
Patients who do not want to participate in the study
Patients with a history of drug or alcohol abuse
Intervention groups
Group A (standard intra-abdominal co2 pressure), group B (low intra-abdominal co2 pressure)
Main outcome variables
postoperative shoulder pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231120060124N1
Registration date:2023-12-19, 1402/09/28
Registration timing:prospective
Last update:2023-12-19, 1402/09/28
Update count:0
Registration date
2023-12-19, 1402/09/28
Registrant information
Name
Alireza Abadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 6001
Email address
dralireza.abadi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-22, 1402/10/01
Expected recruitment end date
2024-04-20, 1403/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of standard gas pressure with low intra-abdominal co2 pressure on postoperative shoulder pain in laparoscopic cholecystectomy patients
Public title
Investigating the effect of intra-abdominal CO2 gas pressure on shoulder pain after laparoscopic cholecystectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 25 to 70 who are diagnosed with symptomatic gallstones or chronic cholecystitis
Exclusion criteria:
Pregnant women
aged <25 years and >70 years
emergency cholecystectomy
jaundice
intraoperative injury to the intestine or bile duct
intraoperative bleeding
gangrenous cholecystitis or emphysema
obstructive jaundice
choledocholithiasis
coagulopathy
rupture of the gallbladder during Surgery or damage to the common bile duct
cholangitis
pancreatitis
gallbladder carcinoma and its abnormalities
previous upper abdominal surgery
patients who do not want to participate in the study
acute cholecystitis
problems Nerves and psyche
failure of the surgeon to use CO2 pressure
Age
From 25 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Data and Safety Monitoring Board
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
This is a triple-blind type of experiment, which will be blind for the people participating in the study and evaluating the outcome and Data Safety and Monitoring Committee. In the consent form to participate in the study, it is written for the patient that his presence does not necessarily mean intervention but may be included in the control group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of qazvin University of Medical Sciences
Street address
Research and Technology deputy ,Mavaddat Alley,Shahid Beheshti Blvd
City
Qazvin
Province
Qazvin
Postal code
3413996134
Approval date
2023-10-15, 1402/07/23
Ethics committee reference number
IR.QUMS.REC.1402.189
Health conditions studied
1
Description of health condition studied
Shoulder pain after laparoscopy
ICD-10 code
M25.5
ICD-10 code description
Pain in joint
Primary outcomes
1
Description
Shoulder pain
Timepoint
3, 6, 12 and 24 hours after the operation
Method of measurement
visual analog score (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: a 10 mm port is inserted through the incision below the umbilicus using the Hasson method, and the abdominal cavity is filled with CO2 gas in group B with a low intra-abdominal pressure of 7-7 mm Hg, and the camera is also inserted into the abdomen through the same port. Under the camera guide, another 10 mm port will be placed under the xiphoid process and two 5 mm ports in the subcostal area. During the process of creating pneumoperitoneum, intra-abdominal pressure, gas volume and gas flow rate are checked, and gallbladder removal will be performed in group B with a low intra-abdominal pressure of 7-8 mmHg. The air behind the liver is completely sucked.
Category
Treatment - Surgery
2
Description
A 10 mm port is inserted through the incision below the umbilicus using the Hasson method, and the abdominal cavity is filled with CO2 gas in group A with a standard intra-abdominal pressure of 14-15 mm Hg, and the camera is also inserted into the abdomen through the same port under the camera guide. Another 10 mm port will be placed under the xiphoid appendage and two 5 mm ports will be placed in the subcostal region. During the process of creating pneumoperitoneum, intra-abdominal pressure, gas volume and gas flow rate are checked, and gallbladder removal will be performed in group A with a standard intra-abdominal pressure of 14-15 mmHg. The air behind the liver is completely sucked.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Velayat hospital
Full name of responsible person
Alireza Abadi
Street address
22 Bahman Blvd., Minoodar region
City
Qazvin
Province
Qazvin
Postal code
3471976161
Phone
+98 28 3379 0620
Email
dralireza.abadi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Seyyed Mehdi Mirhashemi
Street address
Research and Technology deputy ,Mavaddat Alley,Shahid Beheshti Blvd
City
Qazvin
Province
Qazvin
Postal code
3413996134
Phone
+98 28 3333 7006
Email
researchdpt@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Alireza Abadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Bahonar street
City
Qazvin
Province
Qazvin
Postal code
34197-58911
Phone
+98 28 3333 6001
Fax
Email
dralireza.abadi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Alireza Abadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
University campus building, Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
34197-58911
Phone
+98 28 3333 6001
Email
dralireza.abadi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Alireza Abadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
University campus building, Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
34197-58911
Phone
+98 28 3333 6001
Email
dralireza.abadi@gmail.com
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