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Perioperative Analgesia After Knee Arthroplasty

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2015 by Karl Trauner, Landeskrankenhaus Feldbach.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01225484
First Posted: October 21, 2010
Last Update Posted: April 9, 2015
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.
Collaborator:
Medical University of Graz
Information provided by (Responsible Party):
Karl Trauner, Landeskrankenhaus Feldbach
  Purpose
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)

Condition Intervention Phase
Knee Arthroplasty Procedure: Continuous femoral nerve block + periarticular infiltration Procedure: Intraarticular and periarticular ropivacaine Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Perioperative Analgetic Therapy After Knee Arthroplasty

Resource links provided by NLM:


Further study details as provided by Karl Trauner, Landeskrankenhaus Feldbach:

Primary Outcome Measures:
  • Static and dynamic pain scores (VAS) [ Time Frame: 72 h ]

Secondary Outcome Measures:
  • Maximum knee flexion (active/passive)>= 90° [ Time Frame: 72 h ]

Estimated Enrollment: 123
Study Start Date: October 2010
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CFNB, periarticular infiltration Procedure: Continuous femoral nerve block + 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 Name: CFNB plus periarticular infiltration
Active Comparator: Intraarticular catheter, periarticular infiltration Procedure: Continuous femoral nerve block + 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 Name: CFNB plus periarticular infiltration
Procedure: Intraarticular and periarticular ropivacaine
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 Name: Intraarticular ropivacaine plus periarticular ropivavaine

  Eligibility

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01225484


Contacts
Contact: Karl Trauner, M.D. +43 3152 899 3701 karl.trauner@lkh-feldbach.at
Contact: Angelika Rohrleitner, M.D. +43 3152 899 3701 angelika.rohrleitner@lkh-feldbach.at

Locations
Austria
LKH Feldbach Recruiting
Feldbach, Austria, A-8330
Sponsors and Collaborators
Landeskrankenhaus Feldbach
Medical University of Graz
Investigators
Principal Investigator: Karl Trauner, M.D. LKH Feldbach
  More Information

Responsible Party: Karl Trauner, M.D., Landeskrankenhaus Feldbach
ClinicalTrials.gov Identifier: NCT01225484     History of Changes
Other Study ID Numbers: 21-315 ex 09/10
First Submitted: October 19, 2010
First Posted: October 21, 2010
Last Update Posted: April 9, 2015
Last Verified: April 2015

Keywords provided by Karl Trauner, Landeskrankenhaus Feldbach:
Knee arthroplasty, perioperative analgesia

Additional relevant MeSH terms:
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents