The evaluation of intraperitoneal irrigation with bupivacaine %0/5 on postoperative pain control of laparoscopic cholecystectomy patients in comparison with the control group
Determining the effect of intraperitoneal irrigation with bupivacaine %0/5 on postoperative pain control of laparoscopic cholecystectomy patients in comparison with the control group
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 2 on 92 patients. For randomization, kitset.ir website was used to generate random numbers.
Settings and conduct
At the end of the operation and after laparoscopic cholecystectomy, the bed of the gallbladder and the right hemi-diaphragm and on the liver, in the first group of patients with 100 cc of 0.9% normal saline solution containing 20 ml of 0.5 marcaine and in the second group with 100 cc of normal solution 0.9% saline will washed for 10 minutes and then all the liquid in the place is suctioned as much as possible, at the end of the operation in both groups of pneumoperitoneum, it will drained from the entrance of the ports and the air in the back of the liver will also under active suction.
Participants/Inclusion and exclusion criteria
1. Absence of acute cholecystitis
2. No drug addiction
3. Absence of drug sensitivities
4. Absence of mental disorders
5. Not having diabetes
Intervention groups
The first group of patients were washed with 100 cc of 0.9% normal saline solution containing 20 ml of 0.5 marcain and in the second group with 100 cc of 0.9% normal saline solution for 10 minutes.
Main outcome variables
Postoperative pain in laparoscopic cholecystectomy patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221212056794N1
Registration date:2023-01-21, 1401/11/01
Registration timing:registered_while_recruiting
Last update:2023-01-21, 1401/11/01
Update count:0
Registration date
2023-01-21, 1401/11/01
Registrant information
Name
Vahid Salehi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3322 0163
Email address
sums78vhds@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-31, 1401/10/10
Expected recruitment end date
2023-03-01, 1401/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of intraperitoneal irrigation with bupivacaine %0/5 on postoperative pain control of laparoscopic cholecystectomy patients in comparison with the control group
Public title
The evaluation of intraperitoneal irrigation with bupivacaine %0/5 on postoperative pain control of laparoscopic cholecystectomy patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Absence of acute cerebrocystitis
Absence of addiction and drug use
Absence of drug sensitivities
Absence of mental disorders
Not having diabetes
Exclusion criteria:
The presence of severe inflammation and adhesion in the operation site, so that it turns the laparoscopic surgery into a surgical procedure
Rupture of the gallbladder and leakage of bile at the operation site
High bleeding during the operation so that there is a possibility of peritoneal irritation due to the blood in the peritoneum
The patient's unwillingness to continue studying after surgery
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
92
Randomization (investigator's opinion)
Randomized
Randomization description
randomization method using the kitset.ir site to generate random numbers will enter one of the 2 studied groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the method of blinding will be double-blind and the participants will be unaware of the intervention group and the researcher who evaluates the pain intensity will be unaware of the outcome of the variables.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yasuj University of Medical Sciences
Street address
Deputy of research and technology of Yasuj university of medical sciences, Shahid Motahari Blvd; Kohgiluyeh and Boyer-Ahmad Province; Iran.
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Approval date
2022-05-18, 1401/02/28
Ethics committee reference number
IR.YUMS.REC.1401.074
Health conditions studied
1
Description of health condition studied
cholecystectomy
ICD-10 code
K91
ICD-10 code description
Intraoperative and postprocedural complications and disorders of digestive system, not elsewhere classified
Primary outcomes
1
Description
Postoperative pain in laparoscopic cholecystectomy patients
Timepoint
After entering the ward and 6, 12 and 24 hours after surgery
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with 100 cc of 0.9% normal saline solution containing 20 ml of 0.5 marcaine
Category
Treatment - Surgery
2
Description
Control group: Washed with 100 cc of 0.9% normal saline solution for 10 minutes
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Vahid Salehi
Street address
Shahid Beheshti Hospital, Shahid Mohammad Montazeri St. Yasuj city ; Kohgiluyeh and Boyer-Ahmad Province; Iran.
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3322 1813
Email
en@yums.ac.ir
2
Recruitment center
Name of recruitment center
Shahid Jalil Hospital
Full name of responsible person
Vahid Salehi
Street address
Shahid Jalil Hospital, Varzesh St; Yasuj city ; Kohgiluyeh and Boyer-Ahmad Province; Iran.
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3333 7001
Email
en@yums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Seyed Amin Hoseini
Street address
Deputy of research and technology of Yasuj university of medical sciences, Shahid Motahari Blvd; Kohgiluyeh and Boyer-Ahmad Province; Iran.
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3333 7251
Email
en@yums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Vahid Salehi
Position
Assistant Professor of Surgery
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Shahid Beheshti Hospital, Shahid Mohammad Montazeri St. Yasuj city ; Kohgiluyeh and Boyer-Ahmad Province; Iran.
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3322 1813
Email
sums78vhds@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Vahid Salehi
Position
Assistant Professor of Surgery
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Shahid Beheshti Hospital, Shahid Mohammad Montazeri St. Yasuj city ; Kohgiluyeh and Boyer-Ahmad Province; Iran.
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3322 1813
Email
sums78vhds@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Hosein Mohammadzadeh
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Shahid Beheshti Hospital, Shahid Mohammad Montazeri St. Yasuj city ; Kohgiluyeh and Boyer-Ahmad Province; Iran.
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3322 1813
Email
mansoorehm330@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
SPSS file
When the data will become available and for how long
A week
To whom data/document is available
researchers
Under which criteria data/document could be used
Improve treatment
From where data/document is obtainable
Dr. Vahid Salehi
What processes are involved for a request to access data/document