Safety and Efficacy of Cocktail Periarticular Injection in Simultaneous Total Knee Arthroplasty

Study Overview
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Brief Summary
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We investigated the safety and efficacy of the bilateral periarticular cocktail injection at a reduced dosage in patients undergoing simultaneous bilateral total knee arthroplasty.

Detailed Description
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It is hypothesized that intraoperative periarticular injection with cocktail analgesics can reduce postoperative parenteral narcotics use and improve patient satisfaction following total knee arthroplasty. A prospective, randomized trial is conducted to testify the hypothesis above by recruiting patients who go through simultaneous bilateral TKA and observing their postoperative analgesic consumption, visual analog scores and functional recovery. Potential side-effects of the multimodal drugs is also under observation.

Official Title
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Safety and Efficacy of Cocktail Periarticular Injection for Pain Management in Simultaneous Bilateral Total Knee Arthroplasty- A Prospective, Randomized Trial

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: ropivacaine, fentanyl, adrenaline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with tricompartmental knee disease undergoing simultaneous bilateral TKA Exclusion Criteria: diabetes mellitus neuromuscular deficit a known allergy to one of the drugs being injected a history of cardiac disease or arrhythmia requiring special monitoring

Ages Eligible for Study
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Maximum Age: 80 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cocktail analgesia<br>The local infiltration mixture of ropivacaine, fentanyl, adrenaline is used intra-articularly during operation. The patients in the cocktail analgesia group received an injection of 200mg ropivacaine, 100ug fentanyl, and 0.25mg adrenaline into knee collateral ligaments, posterior aspect of the capsule, quadriceps tendon, patellar tendon, fat pad, periosteum, and synovium, along with PCIA morphine postoperatively. | Drug: ropivacaine, fentanyl, adrenaline<br>* The patients in the cocktail analgesia group received an injection of 200mg ropivacaine, 100ug fentanyl, and 0.25mg adrenaline into knee collateral ligaments, posterior aspect of the capsule, quadriceps tendon, patellar tendon, fat pad, periosteum, and synovium, along with PCIA morphine postoperatively.<br>* Other names: Naropin, AstraZeneca;|
| No Intervention: no cocktail injection<br>The patients in the no cocktail injection group received PCIA morphine postoperatively. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the Morphine consumption and PCIA duration |  | 12 hours to 3 days after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the visual analog scale (VAS) in each group patients underwent total knee arthroplasty |  | 4 hours to 5 days after the surgery | 
| Function recovery evaluation for patients received surgery |  | 1, 3 and 5 days after the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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total knee arthroplasty, cocktail analgesia, morphine consumption