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Comparison of the prophylactic effectiveness of intravenous Ibuprofen and intramuscular Piroxicam on pain intensity after lower abdominal surgery under general anesthesia

Protocol summary

Study aim
Comparison of the prophylactic effectiveness of intravenous Ibuprofen and intramuscular Piroxicam on pain intensity after lower abdominal surgery under general anesthesia
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 90 patients. Random allocation software is used for randomization.
Settings and conduct
Immediately after induction of anesthesia and before surgical incision, in the Piroxicam group, 20 milligrams (mg) of intramuscular Piroxicam, in the Ibuprofen group, 400 mg of Ibuprofen and in the control group, intravenous Normal saline is injected and then, at certain hours after surgery, its effect on reducing postoperative pain is compared in three groups. This study is performed in Al-Zahra Hospital in Isfahan. Patients and researcher are not aware of the type of injected drugs.
Participants/Inclusion and exclusion criteria
Class 1 and 2 patients in the American society of Anesthesiology (ASA) classification system aged 25 to 65 years that candidates for lower abdominal surgery without history of drugs, alcohol and benzodiazepine addiction, without history of seizures, psychiatric problems, liver and kidney disease, gastrointestinal bleeding, peptic ulcer and Coagulation disorder No allergy to the drugs used in the study
Intervention groups
In the Piroxicam group, 20 milligrams (mg) of intramuscular Piroxicam, in the Ibuprofen group, 400 mg of Ibuprofen and in the control group, intravenous Normal saline is injected into each patient.
Main outcome variables
Postoperative pain intensity; Average opioids consumption in the first 24 hours after surgery; Mean heart rate and blood pressure during surgery; First time of requesting opioids; Duration of stay in recovery; extubation time; Degree of patient satisfaction with pain relief

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210331050801N1
Registration date: 2021-07-12, 1400/04/21
Registration timing: prospective

Last update: 2021-07-12, 1400/04/21
Update count: 0
Registration date
2021-07-12, 1400/04/21
Registrant information
Name
Zahra Amouaghaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3529 1723
Email address
zr.amouaghaei@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-01, 1400/05/10
Expected recruitment end date
2021-09-01, 1400/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the prophylactic effectiveness of intravenous Ibuprofen and intramuscular Piroxicam on pain intensity after lower abdominal surgery under general anesthesia
Public title
Comparison of the effect of Ibuprofen and Piroxicam on pain relief after surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
ASA1 and ASA2 patient Patient aged 25 to 65 years Patients undergoing lower abdominal surgery No history of drugs, alcohol and benzodiazepine addiction No history of seizures, psychiatric problems, liver and kidney disease, gastrointestinal bleeding, peptic ulcer and Coagulation disorder No allergy to the drugs used in the study
Exclusion criteria:
Age
From 25 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, block randomization method is used. Patients who have the inclusion criteria are selected sequentially so that the first 3 are considered as a block and Then, using random allocation software, they are randomly divided into 3 groups: ibuprofen, piroxicam and control. This process continues until 90 patients enter the study. Thus, we will have equally 30 patients in each group (ibuprofen, piroxicam and control).
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants in study are unaware of the type of drug being injected. An anesthesiologist, who has no role in data collecting, prepares the medication in same volume and injects them. The data collector and the person who evaluating the outcome are not aware of the grouping of patients and the type of injected drug But the data analyzer is informed.
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
Hezar jarib Ave, Azadi Square
City
Isfahan
Province
Isfehan
Postal code
73461-81746
Approval date
2020-07-11, 1399/04/21
Ethics committee reference number
IR.MUI.MED.REC.1399.286

Health conditions studied

1

Description of health condition studied
Postoperative pain
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain

Primary outcomes

1

Description
Intensity of postoperative pain
Timepoint
Immediately after consciousness in recovery and 2, 8, 12 and 24 hours after surgery
Method of measurement
visual analogue scale

2

Description
The amount of opioid used in the first 24 hours after surgery
Timepoint
First 24 hours after surgery
Method of measurement
Reading the patient file

3

Description
Blood pressure
Timepoint
At the beginning of surgery and then every 30 minutes during surgery
Method of measurement
Digital barometer

4

Description
Heart rate
Timepoint
At the beginning of surgery and then every 30 minutes during surgery
Method of measurement
Pulse oximeter

5

Description
Duration of stay in recovery
Timepoint
After leaving the recovery
Method of measurement
Minute

6

Description
Extubation time
Timepoint
After extubation
Method of measurement
Minute

7

Description
The first time of requesting opioid after surgery
Timepoint
After end of surgery
Method of measurement
Minute

8

Description
Degree of patients' satisfaction with pain relief
Timepoint
24 hours after surgery
Method of measurement
Use of visual analogue scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Immediately after induction of anesthesia (which is the same in all 3 groups) and before surgical incision, 20 mg Piroxicam (made by Alborz daroo factory) is injected intramuscularly into patient who is going to have lower abdominal surgery.
Category
Prevention

2

Description
Intervention group: Immediately after induction of anesthesia (which is the same in all 3 groups) and before surgical incision, 400 mg Ibuprofen (made by Caspian factory) is injected intravenously into patient who is going to have lower abdominal surgery.
Category
Prevention

3

Description
Control group: Immediately after induction of anesthesia (which is the same in all 3 groups) and before surgical incision, Normal saline serum (With a volume equal to the other two group`s drug) is injected intravenously into patient who is going to have lower abdominal surgery.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Gholamreza Khalili
Street address
Al-Zahra Hospital, Sofe Blvd.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
khalili@med.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo Javanmard
Street address
Vice chancellor or research and technology, Isfahan University of Medical Sciences, Hezar jarib Ave.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8138
Email
vcr-office@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan 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
Gholamreza Khalili
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Al-Zahra hospital, Sofe Blvd.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 1992
Email
khalili@med.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Khalili
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Al-Zahra hospital, Sofe Blvd.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 1992
Email
khalili@med.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Khalili
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Al-Zahra hospital, Sofe Blvd.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 1992
Email
khalili@med.mui.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
all of data is potentially shareable after unidentifying individuals.
When the data will become available and for how long
Access period starts 6 months after the results are published.
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
use in other studies
From where data/document is obtainable
khalili@med.mui.ac.ir
What processes are involved for a request to access data/document
After sending email, the request is read and reviewed and then will be answered as soon as possible.
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