Fast-track rehabilitation protocol for Total Knee Arthroplasty: A Randomized Controlled Trial comparing Local Infiltration Analgesia with Femoral Nerve Block

Phase 4

Completed

Conditions: Pijnbestrijding bij primaire totale knieprothese
total knee arthroplasty

Registration Number: NL-OMON38898

Lead Sponsor: Sint Maartenskliniek

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 82

Inclusion Criteria

• age 50-80 years
• ASA physical health classification I - II
• patient presents with non-inflammatory primary knee osteoarthritis (radiological confirmation)
• patient planned for a primary unilateral posterior-stabilized tri-compartmental cemented total knee replacement (Genesis II - PS)
• scheduled for fast-track protocol TKA
• patient plans to be available for follow-up through one year postoperative
• written informed consent

Exclusion Criteria

• any contra-indication for regional anesthesia
• any contra-indication for spinal anesthesia
• traumatic osteoarthritis requiring TKA
• an active, local infection or systemic infection
• known hypersensitivity to amide-type local anesthetics
• known hypersensitivity to opioids
• a Body Mass Index (BMI) > 40 kg/m2
• inability to walk independently (inability to walk at least 10 consecutive meters without a walking aid)
• scheduled for contralateral TKA within 1 year post-operative
• scheduled for another operation within 3 months post-operative
• physical, emotional or neurological conditions that would compromise compliance with postoperative rehabilitation and follow-up
• chronic opioid analgesic therapy
• rheumatoid arthritis

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>functional outcome after total knee arthroplasty measured with a performance<br /><br>battery consisting of three functional tasks: Timed-Up-And-Go test, Stair Climb<br /><br>Task en Six Minutes Walk Test. These tests are done: . pre-operatively, 2. when<br /><br>reaching discharge criteria, 3. three months post-operatively, 4. one year<br /><br>post-operatively </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>length of stay, time to reach discharge criteria, quantity and quality of<br /><br>mobilization during hospital stay, pain medication consumption postoperatively<br /><br>(during hospital stay and after hospital discharge), painscores at rest and<br /><br>during mobilization, patient satisfaction with analgesia and the fast track<br /><br>protocol, range of motion of the operated knee, functional outcome of the knee<br /><br>reported by the patient, fear of motion and quality of life.</p><br>