Preemptive Injection of Periarticular-Multimodal Drug for Postoperative Pain Management in Total Knee Arthroplasty: A double-blind randomized clinical trial.
- Main aim:
To investigate the effect of a periarticular multimodal drugs injections preemptively on postoperative pain control and functions of knee following total knee arthroplasty (TKA).
- Type of study:
A double-blind, placebo-controlled, randomized clinical trial.
- Population of study: 120 eligible individuals - aged 30 to 80 years old, were scheduled for primary unilateral Total Knee Arthroplasty.
- Inclusion criteria:
Individuals with osteoarthritis who were scheduled for primary unilateral TKA.
- Exclusion criteria:
BMI greater than 40; previous history of allergy to any medications; known abuser of alcohol and other drugs; any inflammatory arthritis; previous major surgery in the same knee joint indicated for TKA; necessity for bilateral TKA; patient's disinclination for the follow-up.
- Sample size:
120 eligible patients were randomly divided to one of two groups: the intervention group (60) and the control group (60).
Interventions:
Intervention group: Preemptive Injection of Periarticular-Multimodal Drug including Bupivacaine hydrochloride (0.5%) 50 mg, Morphine sulfate10 mg, Epinephrin (1:1000) 300 mcg and ketorolac 30 mg which were all diluted by 0.9 % sodium chloride solution to make a total of 100 ml.
Control group: Preemptive Injection of Epinephrine (1:1000) that also was diluted in 0.9 % sodium chloride to make a total of 100 ml.
Time of intervention:
The injections were given 15 minutes before incision.
- Outcomes:
Primary outcome: Severity of pain.
Secondary outcome: Function of knee joint.
General information
Acronym
TKA: Total knee arthroplasty, KSS: Knee Society Score, VAS: Visual Analog Scale.
IRCT registration information
IRCT registration number:IRCT2016073129132N2
Registration date:2016-08-24, 1395/06/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-08-24, 1395/06/03
Registrant information
Name
Sajad Badiei
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3264 4568
Email address
s_badiei@edc.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2014-11-01, 1393/08/10
Expected recruitment end date
2015-11-30, 1394/09/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Preemptive Injection of Periarticular-Multimodal Drug for Postoperative Pain Management in Total Knee Arthroplasty: A double-blind randomized clinical trial.
Public title
Preventive injection of some types of pain-relief drugs around knee joint for management of pain after complete replacement of knee joint.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: individuals with osteoarthritis who were scheduled for primary unilateral TKA.
Exclusion criteria: BMI greater than 40; previous history of allergy to any medications; known abuser of alcohol and other drugs; any inflammatory arthritis; previous major surgery in the same knee joint indicated for TKA; individuals who were candidated for bilateral TKA; patients who did not show up for the follow-up.
Age
From 30 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Hezarjarib St.
City
Isfahan
Postal code
73461-81746
Approval date
2014-10-21, 1393/07/29
Ethics committee reference number
394048
Health conditions studied
1
Description of health condition studied
Arthrosis of knee (Gonarthrosis)
ICD-10 code
M17.1
ICD-10 code description
Other primary gonarthrosis
2
Description of health condition studied
Severity of pain after Total Knee Arthroplasty
ICD-10 code
T84.8
ICD-10 code description
Other complications of internal orthopaedic prosthetic devices, implants and grafts
3
Description of health condition studied
Total Knee Arthroplasty
ICD-10 code
Z96.8
ICD-10 code description
Presence of other specified functional implants
Primary outcomes
1
Description
the severity of the pain in knee joint.
Timepoint
24 hours, 48 hours and 6 weeks after the surgery
Method of measurement
Visual Analog Scale (VAS)
Secondary outcomes
1
Description
function of knee joint
Timepoint
6 weeks and 6 months after surgery
Method of measurement
Knee Society Score
Intervention groups
1
Description
Intervention group:
Intervention Name: Preemptive Injection of Periarticular-Multimodal Drug
Intervention Description:Injection of a cocktail including Bupivacaine hydrochloride 0.5% (AstraZeneca, Cenexi, France) 50 mg, Morphine sulfate10 mg (Darou Pakhsh, Tehran, Iran), Epinephrin (1:1000) (Darou Pakhsh, Tehran, Iran) 300 mcg and ketorolac (Caspian Tamin, Rasht, Iran) 30 mg which are all diluted by 0.9 % sodium chloride solution to make a total of 100 ml (15 minutes before surgery).
Category
Treatment - Drugs
2
Description
Control group:
Intervention name: Routinely preemptive Injection
Intervention discription: Preemptive Injection of Epinephrine (1:1000) that also been diluted in 0.9 % sodium chloride to make a total of 100 ml (15 minutes before surgery).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayat-Allah Kashani Teaching Hospital
Full name of responsible person
Dr. Mehrdad Rogha
Street address
Ayat-Allah Kashani Street.
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences and Health Cares.
Full name of responsible person
Fariba Vakili
Street address
Hezarjarib St., Isfahan University of Medical Sciences and Health Cares, School of Medicine, Research affairs.
City
Isfahan
Grant name
Grant code / Reference number
394048
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences and Health Cares.
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Sajad Badiei
Position
M.D., Research assistant.
Other areas of specialty/work
Street address
Unit 4, NO 73, Ariya ِDead, Shahid Soltani Alley, Shah Seyed Ali Alley, Abulhasan Isfahani Boulevard.
City
Isfahan
Postal code
8153976191
Phone
+98 31 3264 4568
Fax
Email
s_badiei@edc.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Sajad Badiei
Position
M.D., Research assistant.
Other areas of specialty/work
Street address
Unit 4, NO 73, Ariya Dead, Shahid Soltani Alley, Shah Seyed Ali Alley, Abulhasan Isfahani Boulevard.
City
Isfahan
Postal code
8153976191
Phone
+98 31 3264 4568
Fax
Email
s_badiei@edc.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Sajad Badiei
Position
M.D., Research assistant.
Other areas of specialty/work
Street address
Unit 4, NO 73, Ariya Dead, Shahid Soltani Alley, Shah Seyed Ali Alley, Abulhasan Isfahani Boulevard.
City
Isfahan
Postal code
8153976191
Phone
+98 31 3264 4568
Fax
Email
s_badiei@edc.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)