- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01225484
Perioperative Analgesia After Knee Arthroplasty
April 8, 2015 updated by: Karl Trauner, Landeskrankenhaus Feldbach
Perioperative Analgetic Therapy After Knee Arthroplasty
The purpose of this study is to compare two accepted methods of pain control in knee arthroplasty surgery.The first method combines the periarticular injection of ropivacaine with continuous blockade of the femoral nerve.The second method uses periarticular infiltration of ropivacaine in combination with an bolus of ropivacaine into an intraarticular catheter placed intraoperatively followed by a continuous intraarticular infusion of ropivacaine.
All patient will also receive a sustained-release oral opioid and oral rescue opioids determined by pain severity using the Visual Analog Scale (VAS)
Study Overview
Status
Unknown
Conditions
Study Type
Interventional
Enrollment (Anticipated)
123
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Karl Trauner, M.D.
- Phone Number: +43 3152 899 3701
- Email: karl.trauner@lkh-feldbach.at
Study Contact Backup
- Name: Angelika Rohrleitner, M.D.
- Phone Number: +43 3152 899 3701
- Email: angelika.rohrleitner@lkh-feldbach.at
Study Locations
-
-
-
Feldbach, Austria, A-8330
- Recruiting
- LKH Feldbach
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Elective primary knee arthroplasty
- ASA I,II,&III patients
- Spinal Anaesthesia
Exclusion Criteria:
- Patients refusing consent
- Contraindications to regional anaesthesia
- Preexisting neurological disease
- Alcohol or drug abuse
- Inability to use the outcome assessment tools
- Wheel chair or walker dependent
- Pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: CFNB, periarticular infiltration
|
Initial bolus of ropivacaine 5mg/ml 30mls into the femoral-nerve-catheter preoperatively.
Periarticular infiltration of ropivacaine 2mg/ml 150 mls intraoperatively.
Continuous perineural infusion of ropivacaine 2mg/ml at a rate of 6 mls/hr postoperatively.
Rate can be adjusted to achieve optimal pain control and avoid motor blockade.
Other Names:
|
Active Comparator: Intraarticular catheter, periarticular infiltration
|
Initial bolus of ropivacaine 5mg/ml 30mls into the femoral-nerve-catheter preoperatively.
Periarticular infiltration of ropivacaine 2mg/ml 150 mls intraoperatively.
Continuous perineural infusion of ropivacaine 2mg/ml at a rate of 6 mls/hr postoperatively.
Rate can be adjusted to achieve optimal pain control and avoid motor blockade.
Other Names:
Periarticular infiltration of 150 mls ropivacaine 2mg/ml intraoperatively, intraarticular injection of 40 mls ropivacaine 2 mg/ml at skin closure followed by infusion of ropivacaine 2 mg/ml at a rate of 4 mls/hr delivered by an intraarticular catheter until the morning of postoperative day 3.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Static and dynamic pain scores (VAS)
Time Frame: 72 h
|
72 h
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum knee flexion (active/passive)>= 90°
Time Frame: 72 h
|
72 h
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Karl Trauner, M.D., LKH Feldbach
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2010
Primary Completion (Anticipated)
September 1, 2015
Study Completion (Anticipated)
October 1, 2015
Study Registration Dates
First Submitted
October 19, 2010
First Submitted That Met QC Criteria
October 20, 2010
First Posted (Estimate)
October 21, 2010
Study Record Updates
Last Update Posted (Estimate)
April 9, 2015
Last Update Submitted That Met QC Criteria
April 8, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21-315 ex 09/10
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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