Determining the effect of using an abdominal drain on shoulder pain after gallbladder laparoscopy (PLSP)
Design
A clinical trial with a control group, with parallel groups, randomized, number of 34 samples, the allocation of samples to the intervention groups is done according to the surgeon's order and his diagnosis.
Settings and conduct
This study is a double-blind clinical trial that is conducted in patients with symptomatic gallstones who refer to educational and medical centers in the province and are candidates for laparoscopic cholecystectomy according to the order of the surgeon. Hemovag suction drain will be randomly placed under the liver in a group of patients (group A) and the drain will be removed 24 to 48 hours after surgery in the absence of bile.No drain or tube will be placed in group B patients, and both groups will be given the same antibiotics after the operation. Post-operative pain with pethidine 25 mg intravenously once in the post-anesthesia care unit and acetaminophen suppository every 8 hours in the ward will be given as pain relief for patients. Pain assessment 3, 6, 12 and 24 hours after the operation through visual Analog Score (VAS) will be performed. Safety and data monitoring committee and outcome assessor are blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients aged 25 to 70 who have symptomatic gallstones or chronic cholecystitis.
Exclusion:
Emergency cholecystectomy
Jaundice
Bad history of alcohol and drug use
Explore the common bile duct
Subtotal cholecystectomy
Gallbladder carcinoma and its abnormalities
Previous upper abdominal surgery
Intervention groups
Group A (with abdominal drain), Group B (without drain)
Main outcome variables
Shoulder Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230607058404N1
Registration date:2023-09-02, 1402/06/11
Registration timing:prospective
Last update:2023-09-02, 1402/06/11
Update count:0
Registration date
2023-09-02, 1402/06/11
Registrant information
Name
Mohammadamin Karimlu
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3379 0628
Email address
karimlu.amin@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-06, 1402/06/15
Expected recruitment end date
2024-03-05, 1402/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of using an abdominal drain on shoulder pain after gallbladder laparoscopy (PLSP) in patients referred to Velayat Hospital.
Public title
Investigating the effect of using an abdominal drain on shoulder pain after gallbladder laparoscopy (PLSP)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients diagnosed with symptomatic gallstones or chronic cholecystitis.
Exclusion criteria:
Pregnant women
Age less than 25 years and more than 70 years
Emergency cholecystectomy
Intraoperative injury to the intestine or bile duct
Jaundice
Bad history of alcohol and drug use
Bleeding during surgery
Gangrenous cholecystitis or emphysema
Choledocholithiasis
Coagulopathy
Rupture of the gallbladder during surgery
Explore the common bile duct
Subtotal cholecystectomy
Cholangitis
Pancreatitis
Gallbladder carcinoma and its abnormalities
Previous upper abdominal surgery
Age
From 25 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data and Safety Monitoring Board
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The information of the checklist is provided by the secretary of the department in which people with national codes are registered to the person in charge of the analysis and statistical analysis of the plan. After entering SPSS and coding 1 and 2, the results of the evaluation will be analyzed by the statistics professor, separating the intervention and control groups (which only the secretary of the department knows about). Whether he did or not is unknown. The analyst and the data safety monitoring committee are not aware of which solution the patients received.
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,Qazvin
City
Qazvin
Province
Qazvin
Postal code
3413996134
Approval date
2023-08-19, 1402/05/28
Ethics committee reference number
IR.QUMS.REC.1402.129
Health conditions studied
1
Description of health condition studied
Post laparoscopic shoulder pain
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: After the surgery, a Hemovag suction drain will be randomly placed under the liver in a series of patients (group A) and the drain will be removed 24-48 hours after surgery in the absence of bile.
Category
Treatment - Surgery
2
Description
Control group: No drain or tube will be placed in group B patients
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Velayat hospital
Full name of responsible person
Mohammadamin Karimlu
Street address
22 Bahman Blvd., Minoodar region
City
Qazvin
Province
Qazvin
Postal code
3471976161
Phone
+98 28 3379 0620
Email
aminkarimlu65@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,Qazvin
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
Mohammadamin Karimlu
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
Email
aminkarimlu65@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mohammadamin Karimlu
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
aminkarimlu65@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mohammadamin Karimlu
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
Fax
Email
aminkarimlu65@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