Perioperative Analgesia After Knee Arthroplasty

Sponsor

Landeskrankenhaus Feldbach (Other)

Overall Status

Unknown status

CT.gov ID

NCT01225484

Collaborator

Medical University of Graz (Other)

123

Enrollment

Location

Arms

Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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)

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

123 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Perioperative Analgetic Therapy After Knee Arthroplasty

Study Start Date :

Oct 1, 2010

Anticipated Primary Completion Date :

Sep 1, 2015

Anticipated Study Completion Date :

Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: 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 Names: Intraarticular ropivacaine plus periarticular ropivavaine

Arm

Intervention/Treatment

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 Names:

CFNB plus periarticular infiltration

Active Comparator: Intraarticular catheter, periarticular infiltration

Procedure: Continuous femoral nerve block + periarticular infiltration

Other Names:

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 Names:

Intraarticular ropivacaine plus periarticular ropivavaine

Outcome Measures

Primary Outcome Measures

Static and dynamic pain scores (VAS) [72 h]

Secondary Outcome Measures

Maximum knee flexion (active/passive)>= 90° [72 h]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	LKH Feldbach	Feldbach		Austria	A-8330

Sponsors and Collaborators

Landeskrankenhaus Feldbach
Medical University of Graz

Investigators

Principal Investigator: Karl Trauner, M.D., LKH Feldbach

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Karl Trauner, M.D., Landeskrankenhaus Feldbach

ClinicalTrials.gov Identifier:

NCT01225484

Other Study ID Numbers:

21-315 ex 09/10

First Posted:

Oct 21, 2010

Last Update Posted:

Apr 9, 2015

Last Verified:

Apr 1, 2015

Keywords provided by Karl Trauner, M.D., Landeskrankenhaus Feldbach

Knee arthroplasty, perioperative analgesia

Additional relevant MeSH terms:

Ropivacaine

Study Results

No Results Posted as of Apr 9, 2015