Study question: Is there an ideal combination of intraoperative long acting analgesics (periarticular infiltration (PI), femoral nerve block (FB) and intrathecal opioids (IO)) to optimize post-operative functional recovery, decrease overall narcotic consumption and enable faster 'readiness to discharge' for patients undergoing primary total knee replacement (TKR)?
Our study design is a five-arm double blinded randomized control trial. In order to create a blinded study, each participant will have all three interventions (Femoral Nerve Block (FB), Periarticular Injection (PI) and Intrathecal Opioid (IO)) performed during their visit. Normal saline (NS) will be substituted for opioid or local anesthetic in cases where a control is required. Specific 5 arms include: * Using all three anesthetics: o PI + FB + IO (arm 1) * Using a combination of two anesthetics + normal saline substitute for control: * NS + FB + IO (arm 2) * PI + NS + IO (arm 3) * PI + FB + NS (arm 4) * Control: * NS + NS + IO (arm 5) The control arm would include IO as the sole intervention as this is simply added to the spinal anesthetic used for the surgery itself. It is felt that having a study arm without any long-acting analgesic medication (opioid or local anesthetic) as the "control" arm following a spinal anesthetic would not meet current standard of care and cause harm to the participant The investigators hypothesize that the combination of three forms of long acting analgesia (PI, FB, IO) will result in the greatest outcomes compared to a combination of any two or control. Our aim is to demonstrate that this optimal analgesic combination will have an additive pain control effect and will minimize side effects thus translating to less acute pain, improve patient mobility, and attaining "readiness to discharge" quicker.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
220
Health Sciences North Research Institute
Greater Sudbury, Ontario, Canada
Time to Discharge
Meeting discharge criteria - Participants will be followed for the duration of hospital stay, approximately 3-5 days
Time frame: Post-op day 1 to discharge date or day 5
Time up and go performance measures
Measured by physiotherapists - Functional Outcome - Participants will be followed for the duration of hospital stay, approximately 3-5 days
Time frame: Post-op day1 to discharge date or day 5
Total Opioid Consumption Measures
Narcotic Use and Assessment - Participants will be followed for the duration of hospital stay, approximately 3-5 days
Time frame: Post-op day 0 to discharge date or day 5
Complications
To include nausea, vomiting, pruritis as assessed by Common Terminology Criteria for Adverse Events (CTCAE) - Participants will be followed for the duration of hospital stay, approximately 3-5 days
Time frame: Post-op day 0 to discharge date or day 5
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0.3 ml
30ml
100 ml
100 ml
600 mcg
30 mg
0.5% 1:400,000 30ml