Optimizing Pain and Rehabilitation After Knee Arthroplasty (OPRA)

Sunnybrook Health Sciences Centre

Status and phase: Completed; Phase 3

Conditions: Total Knee Arthroplasty

Treatments: Other: single femoral nerve block; Other: local infiltration analgesia; Other: continuous FNB

Study type: Interventional

Funder types: Other

Identifiers

NCT01616836

011-2012

Details and patient eligibility

About

The aim of this study is to determine the best method of pain control that will help with rehabilitation after total knee arthroplasty (TKA). Currently, the best method for pain control after TKA appears to be continuous femoral nerve block (FNB) where a small tube is placed beside the nerve that provides sensation to a large part of the knee and local anesthetic infused after surgery causing numbness to the surgical site. A single injection method also exists and may provide similar benefits. Both methods require training and can result in side effects such as temporary weakness (while the local anesthetic is still working) that can inhibit rehabilitation. A newer method injecting local anesthetic into the joint after surgery (Local Infiltration Analgesia (LIA)) is becoming common, does not cause weakness and can be done quickly at the end of surgery. It is unknown if the pain control provided by LIA is as good as that of FNB. This study will compare the femoral nerve block, continuous femoral nerve block and LIA technique to determine which provides better pain relief after TKA.

Full description

This will be a prospective, randomized, double blind study. Patients will be randomized using a computer-generated sequence to one of three groups:

Group 1: Continuous femoral nerve block group (cFNB) Group 2: Single injection femoral nerve block group (sFNB) Group 3: Local infiltration analgesia group (LIA)

Inclusion criteria: Patients between the ages of 18 and 85 having primary tri-compartmental total knee arthroplasty.

Exclusion criteria: Allergy, intolerance, or contraindication to any study medication (see below), inability to walk independently prior to TKA, inability to comprehend French or English, use of major tranquilizers, ASA 4 or 5, BMI > 40, opioid tolerance (opioid consumption > 30mg oral morphine or equivalent per day), pregnancy

Enrollment: 100 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults undergoing primary, tri-compartmental knee arthroplasty

Exclusion criteria

• Allergy, intolerance, or contraindication to any study medication
• Inability to walk independently prior to TKA
• Inability to comprehend French or English
• Use of major tranquilizers
• ASA 4 or 5
• BMI > 40
• Opioid tolerance (opioid consumption > 30mg oral morphine or equivalent per day)
• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 3 patient groups

continuous FNB

Active Comparator group

Description:

Bolus femoral nerve block (ropivacaine 0.5% 20 mL), continuous infusion 48 hours (ropivacaine 0.2%, 5 mL/h), placebo local infiltration

Treatment:

Other: continuous FNB

single FNB

Active Comparator group

Description:

femoral nerve block (ropivacaine 0.5% 20 mL), placebo femoral nerve block infusion, placebo local infiltration

Treatment:

Other: single femoral nerve block

LIA

Active Comparator group

Description:

placebo fascia iliac block, placebo fascia iliaca infusion, local infiltration analgesia

Treatment:

Other: local infiltration analgesia