Effect of intraperitoneal irrigation with Ketamine in comparison with lidocaine on Pain following laparoscopic cholecystectomy, a randomized clinical trial
Reducing postoperative pain and improving general condition of patients after laparoscopic cholecystectomy
Design
In this study, patients will be divided into three groups by block randomization and interventions will be done at the end of the operation. The severity of the pain in the shoulders and also in the abdomen and in the upper right quadrant during the specified hours is evaluated and recorded. Additional analgesics requested by the patient will also be checked at specific hours and recorded in the questionnaire.
Settings and conduct
The study will be conducted in the operating room and surgery department of the Semnan Kosar Hospital(Iran).
Participants/Inclusion and exclusion criteria
Inclusion criteria:
All patients with chronic cholecystitis candidate for elective laparoscopic cholecystectomy
Exclusion criteria:
1. Using any drug that can affect on postoperative pain.
2. Addiction to drugs or alcohol (in the past or at present).
3. The presence of acute cholecystitis or empyema of the gallbladder.
4. Presence of severe inflammation and adhesion at the site of surgery so that open surgery is required.
5. Rupture of the gallbladder and bile leakage at the site of surgery.
6. Intraoperative bleeding so that resulted in peritoneal stimulation due to presence of blood in the peritoneum .
Intervention groups
In the first group of patients, the Surgical Site Irrigation will done by 100 cc normal saline 0.9% containing 3 mg / kg Lidocaine 1% for 5-10 minutes.
In the second group of patients, the Surgical Site Irrigation will done by 100 cc of 0.9% saline solution containing 0.5 mg / kg of ketamine for 5 to 10 minutes.
In the third group, the Surgical Site Irrigation will done by 100 ml of normal saline for 5 to 10 minutes.
Then in each of the three groups, the fluid in the surgical site is suctioned as far as possible and at the end of the surgery the peritoneal air will be suctioned and the air in the posterior area of the liver is also actively suctioned.
Main outcome variables
Severity of Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151020024625N6
Registration date:2018-02-27, 1396/12/08
Registration timing:registered_while_recruiting
Last update:2018-02-27, 1396/12/08
Update count:0
Registration date
2018-02-27, 1396/12/08
Registrant information
Name
Mehrdad Zahmatkesh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3343 7844
Email address
mehrdadzahmatkesh@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-12, 1396/07/20
Expected recruitment end date
2018-06-09, 1397/03/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of intraperitoneal irrigation with Ketamine in comparison with lidocaine on Pain following laparoscopic cholecystectomy, a randomized clinical trial
Public title
Effect of Ketamine and lidocaine on Pain following laparoscopic cholecystectomy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Chronic Cholecystitis Candidate for elective Laparoscopic Cholecystectomy
Exclusion criteria:
Presence of severe inflammation and adhesion at the site of surgery so that laparoscopic surgery is not possible.
Rupture of the gallbladder and bile leakage at the site of surgery
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be entered into one of the three groups by block randomization method (6-blocks).
Blinding (investigator's opinion)
Triple blinded
Blinding description
The patient, person who assessing pain and data analyst are not aware of the patient's group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee, Semnan University of Medical Sciences
Street address
Basidj Boulevard
City
Semnan
Province
Semnan
Postal code
3519899951
Approval date
2016-10-01, 1395/07/10
Ethics committee reference number
IR.SEMUMS.REC.1395.94
Health conditions studied
1
Description of health condition studied
Post Operative pain
ICD-10 code
R52
ICD-10 code description
Pain, unspecified
Primary outcomes
1
Description
Severity of Pain
Timepoint
Every 1 hour up to 24 hours after surgery
Method of measurement
VAS: Visual Analog Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Surgical Site Irrigation will done by 100 cc normal saline 0.9% containing 3 mg / kg Lidocaine 1% for 5-10 minutes.Then all the fluid in the surgical site is suctioned as far as possible and at the end of the surgery the peritoneal air will be suctioned and the air in the posterior area of the liver is also actively suctioned.
Category
Treatment - Drugs
2
Description
Intervention group 2: In the second group of patients, the Surgical Site Irrigation will done by 100 cc of 0.9% saline solution containing 0.5 mg / kg of ketamine for 5 to 10 minutes.Then all the fluid in the surgical site is suctioned as far as possible and at the end of the surgery the peritoneal air will be suctioned and the air in the posterior area of the liver is also actively suctioned.
Category
Treatment - Drugs
3
Description
Control group: In the third group, the Surgical Site Irrigation will done by 100 ml of normal saline for 5 to 10 minutes.Then all the fluid in the surgical site is suctioned as far as possible and at the end of the surgery the peritoneal air will be suctioned and the air in the posterior area of the liver is also actively suctioned.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar Hospital
Full name of responsible person
Saeedeh Ataei
Street address
Basidj Boulevard
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3142 2120
Fax
Email
saeidehataei@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohammad Reza Asgari
Street address
Basidj Boulevard
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3344 1022
Email
sem.ums.res@gmail.com
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
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
Semnan University of Medical Sciences
Full name of responsible person
Dr. Hamid Reza Hemmati
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Basidj Boulevard
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3142 2120
Email
dr.hemmati2007@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Hamid Reza Hemmati
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Basidj Boulevard
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3142 2120
Email
dr.hemmati2007@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mehrdad Zahmatkesh
Position
Researcher
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
Basidj Boulevard
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3343 7838
Email
mehrdadzahmatkesh@semums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
Results of statistical Analysis
When the data will become available and for how long
After completing the project
To whom data/document is available
Only the study researchers and Referee
Under which criteria data/document could be used
For similar studies
From where data/document is obtainable
Dr Hamid Reza Hemmati
What processes are involved for a request to access data/document