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

NCT ID: NCT01966263

Last Updated: 2023-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2015-12-31

Brief 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.

Detailed 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.

Conditions

Arthroplasty, Replacement, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Local Infiltration Analgesia (LIA)

local infiltration analgesia is an anesthetic technique that consists of the infiltration of operated tissue with a long acting local anesthetic during surgery to achieve postoperative pain relieve. In this study LIA of the knee will exist of: 1. local infiltration analgesia (LIA) of the posterior capsule of the knee, 2. LIA of the anterior capsule of the knee and 3. LIA of the subcutaneous tissue of the knee

Group Type: ACTIVE_COMPARATOR

LIA of the posterior capsule of the knee

Intervention Type: PROCEDURE

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

Intervention Type: PROCEDURE

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

Intervention Type: PROCEDURE

the surgeon infiltrates the subcutaneous tissue of the knee using 50 mL ropivacaine 0.2% before wound closure.

Femoral Nerve Block (FNB)

a femoral nerve block is an anaesthetic technique that consists of anesthetizing the femoral nerve proximal of the operating area to achieve numbness distal of the block puncture site. A catheter can be placed, so the nerve can be anesthetized continuously or repeatedly for post-operative pain relieve.

In this study the FNB with catheter will be combined with local infiltration analgesia (LIA) of the posterior capsule of the knee

Group Type: ACTIVE_COMPARATOR

LIA of the posterior capsule of the knee

Intervention Type: PROCEDURE

the surgeon infiltrates the posterior capsule of the knee using 100 mL ropivacaine 0.2% with 0.5 mg epinephrine.

FNB with catheter

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

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

Intervention Type: PROCEDURE

Other Intervention Names

Naropin 0.2%; Adrenalin 1mg/mL; local infiltration analgesia; Naropin 0.2%; Adrenalin 1mg/mL; local infiltration analgesia; Naropin 0.2%; local infiltration analgesia; Naropin 0.2%; normal saline; femoral nerve block; continuous femoral nerve block; femoral catheter

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sint Maartenskliniek

OTHER

Sponsor Role: lead

Responsible Party

Maaike Fenten

Anesthesiologist, Head of anesthesiology department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rudolf Stienstra, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Sint Maartenskliniek

Locations

Sint Maartenskliniek

Ubbergen, , Netherlands

Countries

Netherlands

References

Fenten MGE, Bakker SMK, Scheffer GJ, Wymenga AB, Stienstra R, Heesterbeek PJC. Femoral nerve catheter vs local infiltration for analgesia in fast track total knee arthroplasty: short-term and long-term outcomes. Br J Anaesth. 2018 Oct;121(4):850-858. doi: 10.1016/j.bja.2018.05.069. Epub 2018 Jul 26.

Reference Type: DERIVED

PMID: 30236246 (View on PubMed)

Other Identifiers

2013-001008-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NL43965.072.13

Identifier Type: OTHER

Identifier Source: secondary_id

497

Identifier Type: -

Identifier Source: org_study_id