The Efficacy of Periarticular Single Drug Compared With Multimodal Drug Injection in Controlling Pain After TKA

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: single anaesthetic drug
* Drug: multimodal drug injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: multimodal drug injection<br>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 | Drug: multimodal drug injection<br>* inject periarticular tissue of the knee<br>* Other names: anaesthetic cocktail;|
| Active Comparator: Single anaesthetic drug<br>Single anaesthetic drug levobupivacaine 150 mg and epinephrine (1:1000) 0.6 ml (0.6 mg) | Drug: single anaesthetic drug<br>* inject periarticular tissue of the knee after implantation<br>* Other names: chirocaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain score | pain score at rest and activity between 2 groups every 4 hours until 48 hours after surgery | 48 hour after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to request analgesic drug | time when patient request morphine from patient controlled analgesia after intra-operative drug injection | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain control, periarticular injection, Total knee arthroplasty, levobupivacaine, multimodal drug injection