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Perioperative Analgesia After Knee Arthroplasty

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Landeskrankenhaus Feldbach.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Medical University of Graz
Information provided by:
Landeskrankenhaus Feldbach
ClinicalTrials.gov Identifier:
NCT01225484
First received: October 19, 2010
Last updated: June 22, 2011
Last verified: September 2010
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Perioperative Analgetic Therapy After Knee Arthroplasty

Resource links provided by NLM:


Further study details as provided by Landeskrankenhaus Feldbach:

Primary Outcome Measures:
  • Static and dynamic pain scores (VAS) [ Time Frame: 72 h ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maximum knee flexion (active/passive)>= 90° [ Time Frame: 72 h ] [ Designated as safety issue: No ]

Estimated Enrollment: 123
Study Start Date: October 2010
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: September 2012 (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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Karl Trauner, M.D, LKH Feldbach
ClinicalTrials.gov Identifier: NCT01225484     History of Changes
Other Study ID Numbers: 21-315 ex 09/10
Study First Received: October 19, 2010
Last Updated: June 22, 2011
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Landeskrankenhaus Feldbach:
Knee arthroplasty, perioperative analgesia

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

ClinicalTrials.gov processed this record on November 24, 2014