Perioperative Analgesia After Knee Arthroplasty

NCT01225484 | Unknown Phase 4

• 1 other identifier: 21-315 ex 09/10
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

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)

Conditions

Knee Arthroplasty

Keywords

Knee arthroplasty, perioperative analgesia

Outcome Measures

Primary Outcomes (1)

• Static and dynamic pain scores (VAS)

  72 h

Secondary Outcomes (1)

• Maximum knee flexion (active/passive)>= 90°

  72 h

Study Arms (2)

CFNB, periarticular infiltration

ACTIVE COMPARATOR

Procedure: Continuous femoral nerve block + periarticular infiltration

Intraarticular catheter, periarticular infiltration

ACTIVE COMPARATOR

Procedure: Continuous femoral nerve block + periarticular infiltration; Procedure: Intraarticular and periarticular ropivacaine

Interventions

Continuous femoral nerve block + periarticular infiltration PROCEDURE

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.

Also known as: CFNB plus periarticular infiltration

CFNB, periarticular infiltration; Intraarticular catheter, periarticular infiltration

Intraarticular and periarticular ropivacaine PROCEDURE

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.

Also known as: Intraarticular ropivacaine plus periarticular ropivavaine

Intraarticular catheter, periarticular infiltration

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective primary knee arthroplasty
• ASA I,II,\&III patients
• Spinal Anaesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Landeskrankenhaus Feldbach: lead
• Medical University of Graz: collaborator

Study Sites (1)

LKH Feldbach

Feldbach, A-8330, Austria

RECRUITING

Study Officials

• Karl Trauner, M.D.

  LKH Feldbach

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karl Trauner, M.D.

CONTACT

+43 3152 899 3701; karl.trauner@lkh-feldbach.at

Angelika Rohrleitner, M.D.

CONTACT

+43 3152 899 3701; angelika.rohrleitner@lkh-feldbach.at

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: October 19, 2010
• First Posted: October 21, 2010
• Study Start: October 1, 2010
• Primary Completion: September 1, 2015
• Study Completion: October 1, 2015
• Last Updated: April 9, 2015

Record last verified: 2015-04

Locations

AU (1)