Comparison of the effect of intraarticular and periarticular injection of cocktail of morphin epinephrin ropivacain ketorolac on eliminating the postoperative pain after total knee arthroplasty in patients with knee degenerative joint disease
Comparison of the effect of intraarticular and periarticular injection of cocktail of morphin epinephrin ropivacain ketorolac on eliminating the postoperative pain after total knee arthroplasty in patients with knee degenerative joint disease
Design
triple blinded randomised control trial
Settings and conduct
Imam Khomeini hospital, orthopedic surgery room
Participants/Inclusion and exclusion criteria
those with knee osteoarthritis referred to Imam Khomeini hospital for total knee arthroplasty. inclusions: age 18-80 weight 50-120, ability to read wright persian language and complete informed consent form.
exclusions: drug dependence, drug hypersensitivity, neurologic, psychiatric, cardiac renal or liver comorbidity and those with inflammatory arthritis
Intervention groups
1. intraarticular injection of the analgesic cocktail(5mg morphin sulfate, 400 mg ropivacain, 30mg ketorolac, 0.6 cc epinephrin 1/1000) 100cc after suturing the knee capsule at the end of total knee arthroplasty
2. periarticular injection of analgesic cocktail 100cc after inserting the knee prosthesis
3. periarticular injection of analgesic cocktail 50cc after prosthesis instrumentation and injection of another 50cc of the cocktail after suturing the capsule at the end of the surgery
Main outcome variables
the amount of Morphin sulfate injection after the surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210613051559N1
Registration date:2021-06-19, 1400/03/29
Registration timing:registered_while_recruiting
Last update:2021-06-19, 1400/03/29
Update count:0
Registration date
2021-06-19, 1400/03/29
Registrant information
Name
Farzad Vosoughi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8827 0873
Email address
farzadvosooghi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-15, 1400/03/25
Expected recruitment end date
2022-06-15, 1401/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of intraarticular and periarticular injection of cocktail of morphin epinephrin ropivacain ketorolac on eliminating the postoperative pain after total knee arthroplasty in patients with knee degenerative joint disease
Public title
Comparison of the effect of intraarticular and periarticular injection of cocktail of morphin epinephrin ropivacain ketorolac on eliminating the postoperative pain after total knee arthroplasty in patients with knee degenerative joint disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
those aged 18-80
weight between 50-120 kg
ability to read, write and complete informed consent
Exclusion criteria:
drug sensitivity
drug dependence
neurologic disease
psychiatric illness
cardiac disease
liver disease
cardiac arrythmia
Diabetes
neuromuscular problem
inflammatory arthritis e.g. RA
renal disease
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization
triple blind (the patient the analyser and the researcher gathering datea are not informed of the type of allocation)
the allocation of each patient is determined according to the numbers generated by randomization software and is documented in sealed envelope. during the operation, the envelope is opened and the surgeon is informed of the type of allocation at the time of prosthesis insertion by his operative staff.
Blinding (investigator's opinion)
Triple blinded
Blinding description
the allocation of each patient is determined according to the numbers generated by randomization software and is documented in sealed envelope. during the operation, the envelope is opened and the surgeon is informed of the type of allocation at the time of prosthesis insertion by his operative staff.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethical review board of imam khomeini hospital, tehran university of medical sciences
Street address
Imam Khomeini Hospital, End of Keshavarz Blvd, Tehran1419733141, Iran.
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2021-01-27, 1399/11/08
Ethics committee reference number
IR.TUMS.IKHC.REC.1399.434
Health conditions studied
1
Description of health condition studied
knee degenerative joint disease
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
amount of post operative morphin sulfate injection after the total knee arthroplasty
Timepoint
during 72 hr after the total knee arthroplasty
Method of measurement
mg morphin injected by the nursery and documented in the patien's documents
Secondary outcomes
1
Description
visual analogue scale
Timepoint
during 72 h postoperatively 1 week and 1 months after surgery
Intervention group: periarticular injection of analgesic cocktail 100 cc
Category
Rehabilitation
3
Description
Intervention group: intra (50cc) and peri articular (50 cc) injection of analgesic cocktail
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
farzad vosoughi
Street address
Joint Reconstruction Research Center, Orthopedicsurgery department, Imam Khomeini Hospital, End of Keshavarz Blvd, Tehran1419733141, Iran.
City
tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 8827 0873
Email
farzadvosooghi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
farzad vosoughi
Street address
Joint Reconstruction Research Center, Orthopedicsurgery department, Imam Khomeini Hospital, End of Keshavarz Blvd, Tehran1419733141, Iran.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 8827 0873
Email
farzadvosooghi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
seyed mohammad javad mortazavi
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Joint Reconstruction Research Center, Orthopedicsurgery department, Imam Khomeini Hospital, End of Keshavarz Blvd, Tehran1419733141, Iran.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 8827 0873
Email
smjmort@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
farzad vosoughi
Position
researcher
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Joint Reconstruction Research Center, Orthopedicsurgery department, Imam Khomeini Hospital, End of Keshavarz Blvd, Tehran1419733141, Iran.
City
tehran
Province
Tehran
Postal code
1419733141
Phone
009888270873
Email
farzadvosooghi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
farzad vosoughi
Position
researcher
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Joint Reconstruction Research Center, Orthopedicsurgery department, Imam Khomeini Hospital, End of Keshavarz Blvd, Tehran1419733141, Iran.
City
tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 8827 0873
Email
farzadvosooghi@gmail.com
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
Comparision of the effect of intraarticular and periarticular injection of coctail of morphin epinephrin ropivacain ketorolac on eliminating the postoperative pain after total knee arthroplasty in knee arthrotic patients referred to the joint reconstruction research center of imamkhomeini hospital
When the data will become available and for how long
at the end of the study
To whom data/document is available
academic institution
Under which criteria data/document could be used
scientific journal
From where data/document is obtainable
for comparing the clinical outcom the data is aimed to be shared online
What processes are involved for a request to access data/document