Safety and Efficacy of Cocktail Periarticular Injection in Simultaneous Total Knee Arthroplasty
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02270437|
Recruitment Status : Completed
First Posted : October 21, 2014
Last Update Posted : August 28, 2015
|Condition or disease||Intervention/treatment||Phase|
|Pain, Postoperative||Drug: ropivacaine, fentanyl, adrenaline||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Safety and Efficacy of Cocktail Periarticular Injection for Pain Management in Simultaneous Bilateral Total Knee Arthroplasty- A Prospective, Randomized Trial|
|Study Start Date :||June 2014|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||August 2015|
Experimental: 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.
Drug: 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 Name: Naropin, AstraZeneca
No Intervention: no cocktail injection
The patients in the no cocktail injection group received PCIA morphine postoperatively.
- To evaluate the Morphine consumption and PCIA duration [ Time Frame: 12 hours to 3 days after the surgery ]
- To evaluate the visual analog scale (VAS) in each group patients underwent total knee arthroplasty [ Time Frame: 4 hours to 5 days after the surgery ]
- Function recovery evaluation for patients received surgery [ Time Frame: 1, 3 and 5 days after the surgery ]
- Testing of body temperature,routine blood examination [ Time Frame: hospital admission and 1, 3, 5 days after the surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02270437
|Peking Union Medical College Hospital|
|Beijing, Beijing, China, 100005|
|Study Director:||Wu Zhihong, Prof||Peking Union Medical College Hospital|