Comparison of oral gabapentin effect with a dose of intravenous acetaminophen on pain after knee arthroplasty
Design
Clinical trial with control group and two groups of interventional, double-blind, , 15 cases and three groups is assessed.
Settings and conduct
The present study is a double-blind study that is conducted in Ghaem Hospital in Mashhad, and patients and evaluates are unaware.
Participants/Inclusion and exclusion criteria
After approval by the Ethics Committee and approval of the plan at the University Research Committee, all patients with complete knee arthroplasty were enrolled in the study.
Intervention groups
Intervention group 1: Intravenous injection of 1000 mg intravenous acetaminophen within half an hour during surgery
Intervention group 2: Use 600 mg oral gabapentin two hours before surgery
Main outcome variables
Patients' pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190430043424N1
Registration date:2019-05-12, 1398/02/22
Registration timing:registered_while_recruiting
Last update:2019-05-12, 1398/02/22
Update count:0
Registration date
2019-05-12, 1398/02/22
Registrant information
Name
Mohammad Alipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3852 5209
Email address
alipourm1398@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-17, 1398/01/28
Expected recruitment end date
2020-03-20, 1399/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of oral gabapentin with a dose of intravenous acetaminophen on pain after knee arthroplasty
Public title
Comparison of the effect of oral gabapentin with a dose of intravenous acetaminophen on pain after 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:
15
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Sciences
Street address
Department of Anesthesiology, Imam Reza Hospital, Square Taghiabad
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
ICD-10 code
T84.9
ICD-10 code description
Unspecified complication of internal orthopaedic prosthetic device, implant and graft
Primary outcomes
1
Description
Drug measurements
Timepoint
after intervention
Method of measurement
MORPHIN EQUIVALLENT
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
Ghaem Hospital
Full name of responsible person
Dr. Mohammad Alipour
Street address
Ghaem Hospital, Ahmad Abad Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3852 5209
Email
alipourm@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
International Offic Administration Center(Qoreishi Building) ; Daneshgah St.,
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3841 2081
Email
ramresearch@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
Ghaem Hospital, Taghiabad Square
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
Mohammad Alipour
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ghaem Hospital, Taghiabad Square
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
Ghaem Hospital, Taghiabad Square
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
Not applicable
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
Data file
When the data will become available and for how long
6 months after publication
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