Total Knee Arthroplasty
Conditions
Brief summary
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.
Detailed 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
Interventions
OTHERcontinuous FNB
femoral nerve block (ropivacaine 0.5%, 20 mL) with femoral nerve block infusion 48 h (ropivacaine 0.2%, 5mL/h), placebo local infiltration
single femoral nerve block (ropivacaine 0.5%, 20 mL), placebo femoral nerve block infusion, placebo local infiltration
placebo fascia iliac block, placebo fascia iliaca infusion, local infiltration analgesia (tricompartmental injection of 150 mL ropivacaine 0.2%, ketorolac 30 mg, epinephrine 10 microg/mL)
Sponsors
Canadian Anesthesiologists' Society
The Physicians' Services Incorporated Foundation
Sunnybrook Health Sciences Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Rating Scale for Pain | 09h00 on postoperative day 2 | Pain at this time is the primary impediment to beginning physiotherapy and achieving discharge criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee range of motion | Measured each postoperative day (4 day maximum) during daily physiotherapy session | Active and passive range of motion - physical outcome measure |
| Six minute walk test | Measured once at the first postoperative visit with the surgeon, 6 weeks postoperative | Validated functional outcome measure after total knee arthoplasty |
| Timed up and go | Measured once on postoperative day 2 during the physiotherapy session | Functional outcome measure |
| WOMAC | Baseline questionnaire given preoperatively, at first postoperative visit (6 weeks), and second postoperative visit (3 months) | Western Ontario and McMaster University Osteoarthritis Index - functional outcome measure questionnaire |
| LEFS | Baseline questionnaire given preoperatively, at first postoperative visit (6 weeks), and second postoperative visit (3 months) | Lower extremity functional scale - functional outcome questionnaire |
| Opioid consumption | Cumulative 4 day consumption | Opioid consumption is a surrogate outcome for pain. A reduction in opioid consumption also confers benefits of reduced side effects - nausea, dizziness, sedation, respiratory depression |
| Complications of femoral nerve block, local infiltration analgesia | From date of randomization until the first postoperative visit at 6 weeks | hematoma, infection, persistent neurological deficit 6 weeks postoperatively |
| Inability to ambulate/falls | Participants will be followed for the duration of hospital stay, an expected average of 4 days | — |
| Nausea | Participants will be followed for the duration of hospital stay, an expected average of 4 days | — |
| NRS for pain | The highest NRS will be assessed daily during the patient's physiotherapy session, as well as the highest NRS achieved at 2 weeks, 6 weeks, and 3 months postoperatively | Assessing worst pain during physiotherapy, later dates to assess for the incidence of chronic pain |
| Incidence of motor block | Participants will be followed for the duration of hospital stay, an expected average of 4 days | weakness in quadriceps from femoral nerve block can delay physiotherapy and cause falls |
Countries
Canada
Outcome results
None listed