Back to resultsThe Efficacy of Periarticular Single Drug Compared With Multimodal Drug Injection in Controlling Pain After TKA (TKA)
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
single anaesthetic drug
multimodal drug injection
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring pain control, periarticular injection, Total knee arthroplasty, levobupivacaine, multimodal drug injection
Eligibility Criteria
Inclusion Criteria:
- primary osteoarthritis of the knee who undergoing unilateral primary total knee arthroplasty
- age 50-85 years old
Exclusion Criteria:
- unable to perform spinal anaesthesia
- history of drug allergies; local anaesthesia, Non-steroidal anti-inflammatory drugs, morphine, epinephrine
- cognitive function impairment
- renal impairment (creatinine clearance < 30 mL/min)
- liver impairment, gastrointestinal bleeding
Sites / Locations
- department of orthopaedic surgery, Faculty of medicine, Thammasat university
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
multimodal drug injection
Single anaesthetic drug
Arm Description
Multimodal drug injection Levobupivacaine 150 mg, epinephrine(1:1000) 0.6 mL(0.6 mg), morphine sulfate 5 mL(5 mg), ketorolac 1 mL (30 mg) and mixed with normal saline up to 100 mL
Single anaesthetic drug levobupivacaine 150 mg and epinephrine (1:1000) 0.6 ml (0.6 mg)
Outcomes
Primary Outcome Measures
pain score
pain score at rest and activity between 2 groups every 4 hours until 48 hours after surgery
Secondary Outcome Measures
time to request analgesic drug
time when patient request morphine from patient controlled analgesia after intra-operative drug injection
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01898052
Brief Title
The Efficacy of Periarticular Single Drug Compared With Multimodal Drug Injection in Controlling Pain After TKA
Acronym
TKA
Official Title
A Comparative Study on the Efficacy of Periarticular Single Anesthetic Drug Compared With Multimodal Drug Injection in Controlling Pain After Total Knee Arthroplasty: A Double Blinded Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Thammasat University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine the periarticular multimodal drug injection has more efficacy for controlling pain after TKA than single anaesthetic drug injection.
Detailed Description
Many studies have to determine the efficacy of periarticular multimodal drug injection or single local anaesthetic drug comparing with placebo for pain controlled in TKA. But in this study would like to determine which one of both drugs are more efficacy.
In multimodal drug injection consist of levobupivacaine, morphine, ketorolac and epinephrine while single anaesthetic drug has levobupivacaine and epinephrine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
pain control, periarticular injection, Total knee arthroplasty, levobupivacaine, multimodal drug injection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
multimodal drug injection
Arm Type
Experimental
Arm Description
Multimodal drug injection Levobupivacaine 150 mg, epinephrine(1:1000) 0.6 mL(0.6 mg), morphine sulfate 5 mL(5 mg), ketorolac 1 mL (30 mg) and mixed with normal saline up to 100 mL
Arm Title
Single anaesthetic drug
Arm Type
Active Comparator
Arm Description
Single anaesthetic drug levobupivacaine 150 mg and epinephrine (1:1000) 0.6 ml (0.6 mg)
Intervention Type
Drug
Intervention Name(s)
single anaesthetic drug
Other Intervention Name(s)
levobupivacaine, chirocaine
Intervention Description
inject periarticular tissue of the knee after implantation
Intervention Type
Drug
Intervention Name(s)
multimodal drug injection
Other Intervention Name(s)
anaesthetic cocktail
Intervention Description
inject periarticular tissue of the knee
Primary Outcome Measure Information:
Title
pain score
Description
pain score at rest and activity between 2 groups every 4 hours until 48 hours after surgery
Time Frame
48 hour after surgery
Secondary Outcome Measure Information:
Title
time to request analgesic drug
Description
time when patient request morphine from patient controlled analgesia after intra-operative drug injection
Time Frame
48 hours
Other Pre-specified Outcome Measures:
Title
drug consumption
Description
morphine consumption that record from patient controlled analgesia
Time Frame
48 hours
Title
knee score
Description
Knee injury and osteoarthritis outcome score (KOOS) at pre-operation and post-operation 3 months
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
primary osteoarthritis of the knee who undergoing unilateral primary total knee arthroplasty
age 50-85 years old
Exclusion Criteria:
unable to perform spinal anaesthesia
history of drug allergies; local anaesthesia, Non-steroidal anti-inflammatory drugs, morphine, epinephrine
cognitive function impairment
renal impairment (creatinine clearance < 30 mL/min)
liver impairment, gastrointestinal bleeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Supakit Kanitnate, M.D.
Organizational Affiliation
orthopaedics department
Official's Role
Principal Investigator
Facility Information:
Facility Name
department of orthopaedic surgery, Faculty of medicine, Thammasat university
City
Khlong Luang
State/Province
Pathumthani
ZIP/Postal Code
12120
Country
Thailand
12. IPD Sharing Statement
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The Efficacy of Periarticular Single Drug Compared With Multimodal Drug Injection in Controlling Pain After TKA
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