Comparative study of the effect of local infiltration of two doses of Hydrocortisone on pain and nausea and vomiting after laparoscopic cholecystectomy
General purpose :
Determining and comparing the effect of local infiltration of two doses of pre-emptive hydrocortisone on pain, nausea and vomiting(PONV) After laparoscopic cholecystectomy(LC)
Specific purpose :
1) Determining and comparing the mean vas score of pain intensity after surgery
2) Determining and comparing the mean vas score of intensity of PONV
3) Determining and comparing the frequency of vomiting after surgery
4) Determining and comparing the average pethidine consumption of after surgery
5) Determine and compare the average of the first time needed for analgesia
6) Determining and comparing the average of the first time needed for anti-nausea
7) Determining and comparing the frequency percentage of the number of anti-nausea doses received
Design
Clinical trial with control group, three-blind, phase 3 on 105 patients. randomized by random allocation using statistical software.
Settings and conduct
This three-blind clinical trial study will be performed on patients of Alzahra and Ayatollah Kashani Hospital in Isfahan who undergo LC due to chronic cholecystitis.
Participants/Inclusion and exclusion criteria
Inclusion criteria :
1) Age group 85-20 y
2) LC due to chronic cholecystitis
3) ASA physical status one and two
Criteria for non-inclusion :
1) allergy to local anesthetics and drugs, morbid obesity, advanced respiratory diseases, kidney, blood, liver, cardiovascular
2) Chronic use of drug , beta adrenergic receptor antagonists and drug addicts
3) Pregnant women
4) mental retardation
Intervention groups
Group A: receive 100 mg of pre-emptive hydrocortisone at the surgical site.
Group B: Receive 50 mg of pre-emptive hydrocortisone at the surgical site.
Group C: receive cc20 preoperative normal saline at the surgical site
Main outcome variables
Reduce surgical complications، patient and medical center costs; Increase patient satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101211005362N26
Registration date:2021-07-07, 1400/04/16
Registration timing:registered_while_recruiting
Last update:2021-07-07, 1400/04/16
Update count:0
Registration date
2021-07-07, 1400/04/16
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
2021-04-21, 1400/02/01
Expected recruitment end date
2021-12-22, 1400/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of local infiltration of two doses of Hydrocortisone on pain and nausea and vomiting after laparoscopic cholecystectomy
Public title
Effect of local Hydrocortisone on pain and nausea and vomiting after surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age group 85-20 years
Case of laparoscopic cholecystectomy due to chronic cholecystitis
ASA physical status one and two
Exclusion criteria:
Patients with allergies to local anesthetics and drugs, morbid obesity, advanced respiratory diseases, kidney, blood, liver, cardiovascular
Chronic drug use, beta or alcohol adrenergic receptor antagonists, and drug addicts
pregnant women
Mental retardation
Age
From 20 years old to 85 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
The method of randomization in this study is a simple random method using random allocation software, which is an individual randomization unit and random sequencing is done using this software and based on the arrangement presented by patients. Drugs and placebo in syringes together The shape and volume of the preparation are coded depending on the content (1,2,3) and according to the sequence determined by the software, patients receive the desired material. For allocation concealment, the sequentially numbered ,sealed ,opaque envelopes or SNOSE method is used.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this three-blind study of patients and researchers and statistical analysts, the results of the study group and the drug used are not known. Medications are coded. The doctor who injects the medicine only knows the type of medicine, and the information from the study is collected by another doctor who does not know the type of medicine.
Placebo
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
Anesthesiology group, Al-Zahra Educational and Medical Center, Soffe Boulevard, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174675731
Approval date
2021-05-11, 1400/02/21
Ethics committee reference number
IR.MUI.MED.REC.1400.103
Health conditions studied
1
Description of health condition studied
Post operative pain
ICD-10 code
G89.18
ICD-10 code description
Other acute post procedural pain
2
Description of health condition studied
Post operative nausea and vomiting
ICD-10 code
K91.0
ICD-10 code description
Vomiting following gastrointestinal surgery
Primary outcomes
1
Description
Pain Visual Analogue Scale score
Timepoint
In recovery every 15 minutes and up to 24 hours after surgery every 6 hours
Method of measurement
Visual Analogue Scale score
Secondary outcomes
1
Description
Post operative nausea and vomiting Visual Analogue Scale score
Timepoint
In recovery every 15 minutes and up to 24 hours after surgery every 6 hours
Method of measurement
Visual Analogue Scale score
Intervention groups
1
Description
Intervention group 1: consists of 35 people receiving 100 mg of hydrocortisone who receive the drug once and as a preemptive by local infiltration at the site of laparoscopic cholecystectomy 15 minutes before the surgical incision is made.
Category
Treatment - Drugs
2
Description
Intervention group 2: consists of 35 people receiving 50 mg of hydrocortisone who receive the drug once and as a preemptive by local infiltration at the site of laparoscopic cholecystectomy 15 minutes before the surgical incision is made.
Category
Treatment - Drugs
3
Description
Control group: consists of 35 people receiving 20cc of non-drug normal saline (placebo)which is received as a preemptive by local infiltration at the surgical site of laparoscopic cholecystectomy15 minutes before the surgical incision is made.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Dr. Mohammadreza Safavi
Street address
Al-Zahra Educational and Medical Center, Soffe Boulevard, Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-75731
Phone
+98 31 3620 1992
Email
safavi@med.mui.ac.ir
2
Recruitment center
Name of recruitment center
Kashani hospital
Full name of responsible person
Dr. Mohammadreza Safavi
Street address
Kashani street
City
Isfahan
Province
Isfehan
Postal code
81839-83434
Phone
+98 31 3233 0091
Email
safavi@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Shaghayegh Haghjoo Javanmard
Street address
Vice Chancellor for Research and Technology, Building No. 4, Isfahan University of Medical Sciences and Health Services, Hezar Jerib St.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Mohammadreza Safavi
Position
Professor of Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Al-Zahra Educational and Medical Center, Soffe Boulevard , Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 1992
Email
safavi@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Mohammadreza Safavi
Position
Professor of Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Al-Zahra Educational and Medical Center, Soffe Boulevard , Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 1992
Email
safavi@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Mohammadreza Safavi
Position
Professor of Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Al-Zahra Educational and Medical Center, Soffe Boulevard , Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 1992
Email
safavi@med.mui.ac.ir
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