Preemptive comparative study of the effect of Apotel and intravenous Ketorolac on pain after laparoscopic cholecystectomy surgery under general anesthesia
1. Reducing the use of systemic narcotics
2. Reducing the side effects of systemic narcotics following their use
3. Early discharge of the patient from the hospital and reduction of the length of hospitalization
4. Increasing satisfaction of patient and recovery staff by reducing postoperative pain
Design
Clinical trial with control group, with parallel groups, triple blind, randomized, phase 3 on 90 patients. Random allocation software is used for randomization
Settings and conduct
This study is a randomized, triple-blind clinical trial (patient, data collector, and statistical consultant who performs statistical analysis don't know anything about groups in this study) on 90 patients aged 18-65 years with ASA class one and two who Cholecystectomy is performed on them under general anesthesia. Demographic and physiological information of patients are recorded by using pre-prepared information forms. Patients are divided into 3 groups by using random allocation software.
Participants/Inclusion and exclusion criteria
Candidate patients aged 18-65 for laparoscopic cholecystectomy under general anesthesia with ASA class 1 and 2
Addiction, underlying diseases, previous allergies to drugs
Intervention groups
Patients are divided into 3 groups by using random allocation software. Group A recieves 30mg intravenous ketorolac in 50cc normal saline, group B recives 2gr Apotel in 50cc normal saline and group C as a control group recieves 50cc normal saline before general anesthesia and 30minutes before sergical incision .
Main outcome variables
by reducing the post operative pain , sympathetic stimulation and risk of cardiovascular disorder and post operative narcotic use will be reduced.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101211005362N30
Registration date:2022-04-26, 1401/02/06
Registration timing:registered_while_recruiting
Last update:2022-04-26, 1401/02/06
Update count:0
Registration date
2022-04-26, 1401/02/06
Registrant information
Name
Mohammadreza Safavi
Name of organization / entity
Anesthesiology and Critical Care Research Center, Isfahan University of Medical Sciences, Isfahan
Country
Iran (Islamic Republic of)
Phone
+98 31 1273 2659
Email address
safavi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-19, 1400/12/28
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Preemptive comparative study of the effect of Apotel and intravenous Ketorolac on pain after laparoscopic cholecystectomy surgery under general anesthesia
Public title
The effect of Apotel and Ketorolac on pain after surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate patients aged 18-65 years for laparoscopic cholecystectomy under general anesthesia with ASA class 1 and 2
Exclusion criteria:
addiction
underlying disease
drug allergy
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
In this study simple randomization is done and patients are divided into 3 groups (A,B,C) by using random allocation software.
Blinding (investigator's opinion)
Triple blinded
Blinding description
This study is a randomized, triple-blind clinical trial in which the patient and the person collecting the data and the statistical consultant performing the statistical analysis have no knowledge of the groups in this study .
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174675731
Approval date
2022-01-18, 1400/10/28
Ethics committee reference number
IR.MUI.MED.REC.1400.749
Health conditions studied
1
Description of health condition studied
Pain after laparoscopic cholecystectomy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
VAS
Timepoint
Visual Analogue Scale is assessed at 1, 2, 3, 4, 8, 12, and 24 hours after surgery
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients receive 30mg of intravenous Ketorolac in 50cc normal saline before surgical incision
Category
Prevention
2
Description
Intervention group: Patients receive 2gr of Apotel in 50 cc of normal saline before surgical incision
Category
Prevention
3
Description
Control group: Patients receive 50cc of normal saline before surgical incision