Safety and Efficacy of Cocktail Periarticular Injection in Simultaneous Total Knee Arthroplasty
NCT ID: NCT02270437
Last Updated: 2015-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
55 participants
INTERVENTIONAL
2014-06-30
2015-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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cocktail analgesia
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.
ropivacaine, fentanyl, adrenaline
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.
no cocktail injection
The patients in the no cocktail injection group received PCIA morphine postoperatively.
No interventions assigned to this group
Interventions
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ropivacaine, fentanyl, adrenaline
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* neuromuscular deficit
* a known allergy to one of the drugs being injected
* a history of cardiac disease or arrhythmia requiring special monitoring
80 Years
ALL
No
Sponsors
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Peking Union Medical College Hospital
OTHER
Responsible Party
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Zhihong Wu
Prof.
Principal Investigators
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Wu Zhihong, Prof
Role: STUDY_DIRECTOR
Peking Union Medical College Hospital
Locations
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Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Countries
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Other Identifiers
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CBX 726
Identifier Type: -
Identifier Source: org_study_id
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