Comparing the effect of preoperative oral Gabapentin with single dose intravenous Acetaminophen on postoperative pain of knee arthroplasty
Design
Randomised, controlled, superiority, parallel group trial with a sample size of 90 patients.
Settings and conduct
Place: Qaem hospital in Mashhad. Patients are assigned to three groups using randomization software and envelopes. In the first group, 1000 mg of intravenous acetaminophen with the Apotel brand diluted in 100 cc of normal saline and marked with a blue color label is infused during the first half hour during surgery, and the second group is given 600 mg of gabapentin orally with 100 cc water two hours before the operation. The third group, which is the control group, does not receive any medication. During the follow-up period, patients receive painkillers if they have grade four and higher grade pain.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 18-75 years, physical status I or II in ASA (American Society of Anesthesiology), no allergy to gabapentin, absence of mental disorders, not using of alcohol, narcotics, painkillers, corticosteroids and anticonvulsant drugs regularly or in last twenty-four hours.
Intervention groups
Intervention group1: Infusion of 1000 milligrams of intravenous acetaminophen during the first half-hour during surgery. Intervention group 2: Assumption of 600 mg oral gabapentin two hours before surgery. Control group: No drugs.
Main outcome variables
Primary outcome: Drug measurements; Secondary outcome: Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100920004780N12
Registration date:2023-09-05, 1402/06/14
Registration timing:prospective
Last update:2023-09-05, 1402/06/14
Update count:0
Registration date
2023-09-05, 1402/06/14
Registrant information
Name
Mohammad Alipour
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1801 2612
Email address
alipourm@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-07, 1402/07/15
Expected recruitment end date
2024-10-06, 1403/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of preoperative oral Gabapentin with single dose intravenous Acetaminophen on postoperative pain of knee arthroplasty
Public title
Comparing the effect of preoperative oral Gabapentin with single dose intravenous Acetaminophen on postoperative pain of knee arthroplasty
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Physical grade I or II in ASA Lack of sensitivity to Gabapentin The absence of mental disorders Do not drink alcohol, drugs, and taking constipation, and corticosteroids and anticonvulsants on a regular basis or in the past twenty four hours No pregnancy No myasthenia grave disease Not having any kidney disease
Exclusion criteria:
The occurrence of any surgical complications during surgery Reduce or increase the average blood pressure (MAP) Heart rate is greater than 30% of the initial rate
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization. Allocation concealment method is sealed envelopes system. Patients are assigned to three groups using randomization software and sealed envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a double-blind that the name of the drug is in closed envelopes, and the patients and the investigator are not aware of the type of drug.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of Mashhad university of medical science
Street address
Department of Anesthesiology, Imam Reza hospital, Daneshgah street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Approval date
2018-12-18, 1397/09/27
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1397.753
Health conditions studied
1
Description of health condition studied
knee arthroplasty surgery
ICD-10 code
T84.9
ICD-10 code description
Unspecified complication of internal orthopedic prosthetic device, implant and graft
Primary outcomes
1
Description
Drug measurements
Timepoint
After intervention
Method of measurement
Morphin equivalent
Secondary outcomes
1
Description
Pain
Timepoint
After intervention
Method of measurement
Visual analogue scale
Intervention groups
1
Description
Intervention group1: Infusion of 1000 milligrams of intravenous Acetaminophen during the first half-hour during surgery
Category
Treatment - Drugs
2
Description
Intervention group: Assumption of 600 mg oral Gabapentin two hours before surgery
Category
Prevention
3
Description
Control group: No drugs
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Qaem hospital
Full name of responsible person
Mohammad Alipour
Street address
Anesthesia department, Qaem hospital, Ahmad-Abad street
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3840 0001
Email
alipourm@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayourmobarhan
Street address
Deputy of research and technology, Qoreshi building, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
ghayourm@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Alipour
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesia department, Qaem hospital, Ahmad-Abad street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3852 5209
Email
alipourm@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammd Alipour
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesia Department, Qaem hospital, Ahmad-Abad street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3852 5209
Email
alipourm@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Alipour
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesia department, Qaem hospital, Ahmad-Abad street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3852 5209
Email
alipourm@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after patients are made unidentifiable.
When the data will become available and for how long
Data can be accessible 6 months after results are published.
To whom data/document is available
people working in academic institutions
Under which criteria data/document could be used
Statistical analyzes are permitted in overview articles on delivered data.
From where data/document is obtainable
Send an email to Alipourm@mums.ac.ir.
What processes are involved for a request to access data/document
After sending a request email to the corresponding author, data will be sent in one month.