Determining and comparing the preemptive analgesic effect of meloxicam and acetaminophen after inguinal hernia repair surgery
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 58 patients. "Random allocation" computer software will be used for randomization.
Settings and conduct
Patients are studied at Imam Khomeini Hospital in Urmia. After assigning to the group and performing the intervention, the patient enters the operating room and the surgery is performed. The examination of the patient's pain intensity will be done at 4, 12, and 24 hours after the surgery with the Visual Analogue Scale (VAS.)
Participants/Inclusion and exclusion criteria
Male patients who are eligible and willing to participate in the study are included in the study after obtaining written consent. Exclusion criteria include duration of surgery of more than one hour, amount of intraoperative bleeding more than 6 ml/kg, history of liver or kidney disease, drug addicts or alcoholic patients or continuous use of any related drugs, the urgency of surgery, gastrointestinal problems and taking painkillers 24 hours before surgery.
Intervention groups
The studied patients are randomly divided into two equal groups A and B. Before entering the operating room, group A will receive 15 mg of meloxicam, group B will receive 15 mg/kg of acetaminophen.
Main outcome variables
Pain intensity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221126056613N8
Registration date:2024-05-18, 1403/02/29
Registration timing:prospective
Last update:2024-05-18, 1403/02/29
Update count:0
Registration date
2024-05-18, 1403/02/29
Registrant information
Name
aliakbar nasiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3346 9931
Email address
nasiriali7@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2024-08-22, 1403/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Pre-emptive Analgesic Effect of Oral Meloxicam with Oral Acetaminophen After Inguinal Hernia Repair Operations
Public title
Comparison of the Pre-emptive Analgesic Effect of Oral Meloxicam with Oral Acetaminophen After Inguinal Hernia Repair Operations
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosed with inguinal hernia
American Society of Anesthesiology grade 1 physical status patients
Candidate for inguinal hernia repair surgery
Exclusion criteria:
Age
From 18 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
58
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into two groups in a simple random manner using the numbers given by "Random Allocation" computer software. The randomization method is such that each patient is given a code and then the codes are written on a piece of paper, and after mixing the pieces of paper together, a piece of paper is randomly taken out each time and the code is related to the patient. In a list, the first 28 codes will be in the case group and the second 28 will be in the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The procedure will be performed blindly and without the knowledge of the patients and the surgeon, so the study will be double-blind. Also, with the advice of a pharmaceutics expert, the pharmaceutical forms of the two groups will be designed the same.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Research of Imam Khomeini Medical Education Center of Urmia University of Medica
Street address
Emam Khomeini University Hospital, Ershad Ave., Modarres Blvd.
City
Urmia
Province
West Azarbaijan
Postal code
5715789397
Approval date
2024-01-31, 1402/11/11
Ethics committee reference number
IR.UMSU.HIMAM.REC.1402.146
Health conditions studied
1
Description of health condition studied
Inguinal hernia
ICD-10 code
K40
ICD-10 code description
Inguinal hernia
Primary outcomes
1
Description
Pain intensity
Timepoint
4, 12, and 24 hours after the surgery
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: Oral meloxicam 15 mg, single dose
Category
Treatment - Drugs
2
Description
Second intervention group: oral acetaminophen 15 mg/kg, single dose
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital Urmia
Full name of responsible person
Ramin nasiri
Street address
Emam Khomeini University Hospital, Ershad Ave., Modarres Blvd.
City
Urmia
Province
West Azarbaijan
Postal code
5715789397
Phone
+98 991 564 5228
Email
raminnasiri13788@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Saber Gholizadeh
Street address
Research and Technology Vice-Chancellor, West Azarbaijan University of Medical Sciences and Healthcare Services, Emergency Room, Resalat Blvd., Urmia
City
Urmia
Province
West Azarbaijan
Postal code
57146154637
Phone
+98 44 3223 1930
Email
sabergholizadeh@yahoo.com
Web page address
http://umsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia University of Medical Sciences
Proportion provided by this source
10
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
Oroumia University of Medical Sciences
Full name of responsible person
Aliakbar Nasiri
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Emam Khomini university hospital, Ershad Ave., Modarres Blvd.
City
Urmia
Province
West Azarbaijan
Postal code
5715781351
Phone
+98 44 3345 7286
Email
Nasiriali7@gmail.com
Web page address
https://umsu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Aliakbar Nasiri
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Imam khomeini Hospital, Ershad Ave.
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 915 341 6876
Email
nasiriali7@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Aliakbar Nasiri
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Khomeini Hospital, Ershad Ave.
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 915 341 6876
Email
nasiriali7@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All data is shareable.
When the data will become available and for how long
One year after the results are published
To whom data/document is available
It will be available only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
After analyzing the data
From where data/document is obtainable
Imam Khomeini Hospital Urmia
What processes are involved for a request to access data/document
Refer to the Research Department of Imam Khomeini Hospital in Urmia