Study of the effectiveness of adding magnesium sulfate to Ropivacaine comparing to the addition of Tramadol to Ropivacaine on the beginning of analgesia and the level of block and analgesia in patients undergoing lower limb orthopedic surgery
Study of the effectiveness of adding magnesium sulfate to Ropivacaine comparing to the addition of Tramadol to Ropivacaine on the beginning of analgesia and the level of block and analgesia in patients undergoing lower limb orthopedic surgery
Design
This study is a double-blinded clinical trial. The study population will be included all patients undergoing lower limb surgery who will refer to Taleghani Hospital of Kermanshah city.110 eligible patients will be selected conveniently and randomly will bebe assigned to two intervention groups.
Settings and conduct
This study that will be conducted in Taleghani hospital of Kermanshah city is double-blinded one. In this way that patients and researchers will be blinded to the study groups, the dosage of the drug and the manufacturer of the medicine. At the beginning of the study, the diastolic and systolic blood pressure, and the number of pulses of both groups are recorded in a checklist.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Age between 16 -60 years; Anesthesia level 1 to 10
Exclusion criteria: Patients with underlying illness include high blood pressure, pulmonary disease, cardiovascular disease; Drug users patients
Intervention groups
The first intervention group in addition to Rupivacaine ,will receive 100 mg magnesium sulfate 15 minutes before the surgery. The second intervention group, in addition to Rupivacaine will receive 10 mg tramadol 15 minutes before the surgery
Main outcome variables
Pain; nausea
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N116
Registration date:2019-03-10, 1397/12/19
Registration timing:prospective
Last update:2019-03-10, 1397/12/19
Update count:0
Registration date
2019-03-10, 1397/12/19
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-16, 1397/12/25
Expected recruitment end date
2019-06-15, 1398/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effectiveness of adding magnesium sulfate to Ropivacaine comparing to the addition of Tramadol to Ropivacaine on the beginning of analgesia and the level of block and analgesia in patients undergoing lower limb orthopedic surgery
Public title
Study of the effectiveness of adding magnesium sulfate to Ropivacaine comparing to the addition of Tramadol to Ropivacaine on the beginning of analgesia in patients undergoing lower limb orthopedic surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 16 -60 years
Anesthesia level 1 to 10
Exclusion criteria:
Patients with underlying illness include high blood pressure, pulmonary disease, cardiovascular disease
Drug users patients
Age
From 16 months old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
115
Randomization (investigator's opinion)
Randomized
Randomization description
Randomly Individually by random number table via code receipt
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients and researcher will be blinded to the study groups, the dosage of the drug and the manufacturer of the drug
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2018-12-26, 1397/10/05
Ethics committee reference number
ir.kums.rec.1397.790
Health conditions studied
1
Description of health condition studied
Postoperative pain of lower limb orthopaedic surgery
ICD-10 code
M79.6
ICD-10 code description
Pain in limb, hand, foot, fingers and toes
Primary outcomes
1
Description
Pain
Timepoint
The beginning and end of the study
Method of measurement
Based on the visual scale of pain
2
Description
Nausea
Timepoint
The beginning and end of the study
Method of measurement
Asking the patient
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group in addition to Rupivacaine ,will receive 100 mg magnesium sulfate ,15 minutes before the surgery
Category
Treatment - Drugs
2
Description
The second intervention group, in addition to Rupivacaine will receive 10 mg tramadol 15 minutes before the surgery
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Behnam Yari Bajlani
Street address
Taleghani Hospital, Shahid Beheshti Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 7985
Email
dr_m20081362@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Behnam Yari Bajlani
Position
M.A student of special care
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Taleghani Hospital, Shahid Beheshti Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 7985
Email
dr_m20081362@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Maryam Rahmatinejad
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Taleghani Hospital, Shahid Beheshti Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 7985
Email
dr_m20081362@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Behnam Yari Bajlani
Position
M.A student of special care
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Taleghani Hospital, Shahid Beheshti Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 7985
Email
dr_m20081362@yahoo.com
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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The main outcomes of the study will be shared
When the data will become available and for how long
3 months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Collected data is confidential and will not be shared with anyone else
From where data/document is obtainable
To receive the documentation, email send for update manager
What processes are involved for a request to access data/document
In a 15-day period, the documents will be sent e-mail