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Comparison of local infiltration analgesia and epidural analgesia in postoperative pain management, functional outcomes and blood loss control in total knee arthroplasty : A randomized clinical trial

Protocol summary

Study aim
The goal of this randomized clinical trial is to evaluate the efficacy of LIA in patient who received spinal anesthesia in comparison with epidural analgesia combined with pain control infusion pump.
Design
Computer generated permutation digit method
Settings and conduct
Taleghani Hospital
Participants/Inclusion and exclusion criteria
TKA revision Bilateral TKA Collagen vascular disease Neurovascular disease Hematologic disease Coagulopathy Inclusion : 50 - 85 years old with knee pain Don't response to conservative treatment
Intervention groups
Inter articular (knee) injection Pain pump
Main outcome variables
ROM Bleeding SLR Pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170807035554N1
Registration date: 2018-06-27, 1397/04/06
Registration timing: registered_while_recruiting

Last update: 2018-06-27, 1397/04/06
Update count: 0
Registration date
2018-06-27, 1397/04/06
Registrant information
Name
arash sajadi
Name of organization / entity
shaheed beheshti university of medicalscience
Country
Iran (Islamic Republic of)
Phone
+98 912 337 7215
Email address
arashsajadi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-26, 1397/04/05
Expected recruitment end date
2018-08-23, 1397/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of local infiltration analgesia and epidural analgesia in postoperative pain management, functional outcomes and blood loss control in total knee arthroplasty : A randomized clinical trial
Public title
Comparison of local infiltration analgesia and epidural analgesia in postoperative pain management, functional outcomes and blood loss control in total knee arthroplasty
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
50 - 85 years old with knee pain Don't response to conservative treatment
Exclusion criteria:
TKA revision Bilateral TKA Collagen vascular disease Neurovascular disease Hematologic disease Coagulopathy
Age
From 50 years old to 85 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Computer generated permutation digit method
Blinding (investigator's opinion)
Double blinded
Blinding description
No information of who get treatment for health care & patients.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Yaman st
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2018-05-16, 1397/02/26
Ethics committee reference number
IR.SBMU.MSP.REC.1397.260

Health conditions studied

1

Description of health condition studied
Osteoarthritis of Knee
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of Knee

Primary outcomes

1

Description
ROM Bleeding SLR Pain
Timepoint
2 Days & 2 Weeks
Method of measurement
A questionnaire based on VAS-Score

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Local Infiltration Analgesia
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Arash sajadi
Street address
Yaman st
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2560
Email
arashsajadi@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Arash sajadi
Street address
Yaman st
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2560
Email
arashsajadi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Arash sajadi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Yaman st
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 23 0311
Email
arashsajadi@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Arash sajadi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Yaman st
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 23 0311
Email
arashsajadi@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Arash Sajad
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Yaman st
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
arashsajadi@sbmu.ac.ir
Email
arashsajadi@sbmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
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