Fast Track Total Knee Arthroplasty: Local Infiltration Analgesia vs Femoral Nerve Block

Arthroplasty, Replacement, Knee Clinical Trial

Official title:

Fast-track Rehabilitation Protocol for Total Knee Arthroplasty: A Randomized Controlled Trial Comparing Local Infiltration Analgesia With Femoral Nerve Block

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01966263
• Other study ID #: 497
• Secondary ID: 2013-001008-13NL
• Status: Completed
• Phase: Phase 4
• Start date: November 2013
• Est. completion date: December 2015

Study information

• Verified date: April 2022
• Source: Sint Maartenskliniek
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to determine whether either a femoral nerve block (FNB) or local infiltration analgesia (LIA) is a better anesthetic technique to achieve optimal functional outcome after one year in patients receiving a total knee arthroplasty and following a fast track rehabilitation protocol.

Description:

For an optimal and fast recovery after total knee arthroplasty (TKA), a fast track rehabilitation protocol has been developed. The literature is not yet conclusive about the optimal anesthestic technique. The optimal technique should support fast mobilization by giving good pain relieve with minimal side effects such as nausea, drowsiness and muscle weakness. If pain relieve is optimal, the patient mobilizes fast and length of stay is shortened. But does fast recovery lead to better functional outcome? The objective of this study is to determine whether either a femoral nerve block (FNB) or local infiltration analgesia (LIA) is a better anesthetic technique to achieve optimal functional outcome after one year in patients receiving a total knee arthroplasty and following a fast track rehabilitation protocol.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists (ASA) physical health status I-II

• patient presents with non-inflammatory primary knee osteoarthritis (radiological confirmation)

• patient is planned for a primary unilateral posterior-stabilized tri-compartmental cemented total knee replacement (Genesis II - PS)

• patient is scheduled for fast track protocol

• patient plans to be available fot follow-up through one year post-operative

• written informed consent

Exclusion Criteria:

• any contra-indication for locoregional 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 intolerance or contraindication for opioids, nonsteroidal antiinflammatory drugs (NSAIDs) or paracetamol

• a Body Mass Index > 40 kg/m2

• inability to walk independently (inability to walk at least 10 consecutive meters without a walking aid)

• scheduled for contralateral TKA within one year postoperative

• scheduled for another operation within 3 months postoperative

• physical, emotional or neurological conditions that would compromize compliance with postoperative rehabilitation and follow-up

• chronic opioid analgesic therapy

• chronic gabapentin or pregabalin analgesic therapy

• rheumatoid arthritis

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Knee

Intervention

Procedure:
• LIA of the posterior capsule of the knee
the surgeon infiltrates the posterior capsule of the knee using 100 mL ropivacaine 0.2% with 0.5 mg epinephrine.
• LIA of the anterior capsule of the knee
the surgeon infiltrates the anterior capsule of the knee using 50 mL ropivacaine 0.2% with 0.25 mg epinephrine.
• LIA of the subcutaneous tissue of the knee
the surgeon infiltrates the subcutaneous tissue of the knee using 50 mL ropivacaine 0.2% before wound closure.
• FNB with catheter
pre-operatively the anesthesiologist will ultrasound guided place a catheter close to the femoral nerve using sodium chloride (NaCl 0.9%) (no local anesthetic). During surgery, when the LIA of the posterior capsule is performed, 20 mL ropivacaine 0.2% will be administered through the catheter to create a femoral nerve block (FNB). Postoperatively patients will receive 20 mL ropivacaine 0.2% through the catheter 6 times daily for 24 hours

Locations

Country	Name	City	State
Netherlands	Sint Maartenskliniek	Ubbergen

Sponsors (1)

Lead Sponsor	Collaborator
Sint Maartenskliniek

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stair Climbing Task (SCT)	The SCT assesses the ability to ascend and descend a flight of stairs, as well as lower extremity strength, power, and balance.	one year
Secondary	Timed Up and Go Test (TUG)	The TUG assesses basic mobility skill as well as strength, balance, and agility. Originally developed for frail elderly people as the "Get-Up and Go Test" in 1986, it was adapted in 1991 to include the "time" component. The TUG is used in a range of populations from children to the elderly and for many conditions, including osteoarthritis, joint arthroplasty, rheumatoid arthritis, hip fractures, stroke, vertigo, and cerebral palsy.	1 year
Secondary	Six Minute Walking Test (6MWT)	The 6MWT assesses endurance and ability to walk over longer distances. The 6MWT was first described as a field test for physical fitness in 1963 and then as a 12-minute walk test in people with chronic bronchitis. The 6MWT was found to perform as well as the 12-minute walk, and is now used to assess the submaximal level of functional performance at a similar level required for daily physical activities.; Used in many conditions, such as osteoarthritis, cardiopulmonary disease, stroke, traumatic brain injury, patients who have undergone an amputation, Parkinson's disease, and Alzheimer's disease, as well as in elderly populations and children.	1 year