Periarticular Multimodal Drug Injections in Total Knee Arthroplasty

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tae Kyun Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00901628
First received: May 13, 2009
Last updated: December 15, 2012
Last verified: December 2012
Results First Received: May 15, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Osteoarthritis, Knee
Interventions: Drug: ropivacaine
Drug: morphine sulfate
Drug: ketorolac
Drug: epinephrine
Drug: cefuroxime

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
101 patients who were scheduled for unilateral total knee arthroplasty recruitment at Joint Reconstruction Center, Seoul National University Bundang hospital from April 2008 to March 2009 were recruited.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
no participant was excluded before assignment

Reporting Groups
  Description
Periarticular Injection Group Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime
No Injection Group usual postoperative care using the continuous femoral nerve block, IV-PCA and preemptive oral medications without periarticular injection

Participant Flow:   Overall Study
    Periarticular Injection Group     No Injection Group  
STARTED     49     52  
COMPLETED     45     42  
NOT COMPLETED     4     10  
disconnection of catheter                 4                 8  
disconnection of drain                 0                 1  
peroneal nerve palsy                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Periarticular Injection Group Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime
No Injection Group usual postoperative care without periarticular injection
Total Total of all reporting groups

Baseline Measures
    Periarticular Injection Group     No Injection Group     Total  
Number of Participants  
[units: participants]
  49     52     101  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     9     8     17  
>=65 years     40     44     84  
Age  
[units: years]
Mean ± Standard Deviation
  70.2  ± 7.1     70.1  ± 4.9     70.1  ± 6.1  
Gender  
[units: participants]
     
Female     44     48     92  
Male     5     4     9  
Region of Enrollment  
[units: participants]
     
Korea, Republic of     49     52     101  



  Outcome Measures
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1.  Primary:   Pain( Visual Analog Scale )   [ Time Frame: the night after surgery ]

2.  Secondary:   Intravenous Patient Controlled Analgesia(PCA) Consumption During 24 Hours After Surgery   [ Time Frame: 24 hours postoperative ]

3.  Secondary:   Participant Number of Postoperative Nausea and Vomiting During 24 Hours After Surgery   [ Time Frame: 24 hours after surgery ]

4.  Secondary:   the Proportion of Patients Who Were Satisfied With the Pain Management   [ Time Frame: postoperative 7 day ]

5.  Secondary:   The Proportion of Patients Who Could Raise Leg With Replaced Knee Extended   [ Time Frame: 24 hours postoperative ]

6.  Secondary:   Maximal Flexion Angle Degree on Postoperative 7 Day   [ Time Frame: postoperative 7 day ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Tae Kyun Kim
Organization: Joint Reconstruction Center, Seoul National University Bundang Hospital
phone: 82-31-787-7196
e-mail: osktk@snubh.org


No publications provided


Responsible Party: Tae Kyun Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00901628     History of Changes
Other Study ID Numbers: B-0804/056-021
Study First Received: May 13, 2009
Results First Received: May 15, 2009
Last Updated: December 15, 2012
Health Authority: Korea: Food and Drug Administration