Perioperative Analgesia After Knee Arthroplasty

Knee Arthroplasty Clinical Trial

Official title:

Perioperative Analgetic Therapy After Knee Arthroplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01225484
• Other study ID #: 21-315 ex 09/10
• Status: Recruiting
• Phase: Phase 4
• First received: October 19, 2010
• Last updated: April 8, 2015
• Start date: October 2010
• Est. completion date: October 2015

Study information

• Verified date: April 2015
• Source: Landeskrankenhaus Feldbach
• Contact: Karl Trauner, M.D.
• Phone: +43 3152 899 3701
• Email: karl.trauner[@]lkh-feldbach.at
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial Summary

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 123
• Est. completion date: October 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Arthroplasty

Intervention

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.
• 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.

Locations

Country	Name	City	State
Austria	LKH Feldbach	Feldbach

Sponsors (2)

Lead Sponsor	Collaborator
Landeskrankenhaus Feldbach	Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Static and dynamic pain scores (VAS)		72 h	No
Secondary	Maximum knee flexion (active/passive)>= 90°		72 h	No