Knee Replacement, Total
Conditions
Brief summary
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)?
Detailed description
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.
Interventions
DRUGBupivicaine
15mg
DRUGFentanyl
15mcg
DRUGEpimorphine
150mcg
DRUGNormal Saline
0.3 ml
DRUGRopivicaine
100 ml
DRUGEpinephrine
600 mcg
DRUGKetorolac
30 mg
DRUGRopivicaine with Epinephrine
0.5% 1:400,000 30ml
Sponsors
Health Sciences North Research Institute
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 No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older * primary total knee replacement for osteoarthritis * agrees to a spinal anesthetic for TKR
Exclusion criteria
* History of chronic pain or opioid tolerance (individuals requiring equivalent of 1 mg or more intravenous or 3 mg or more oral morphine per hour for greater than 1 month) * general anesthetic for TKR * major neurological deficit * allergy to local anesthetic * allergy to morphine or hydromorphone, anti-inflammatory, acetaminophen * renal insufficiency * liver failure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Discharge | Post-op day 1 to discharge date or day 5 | Meeting discharge criteria - Participants will be followed for the duration of hospital stay, approximately 3-5 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time up and go performance measures | Post-op day1 to discharge date or day 5 | Measured by physiotherapists - Functional Outcome - Participants will be followed for the duration of hospital stay, approximately 3-5 days |
| Total Opioid Consumption Measures | Post-op day 0 to discharge date or day 5 | Narcotic Use and Assessment - Participants will be followed for the duration of hospital stay, approximately 3-5 days |
| Complications | Post-op day 0 to discharge date or day 5 | 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 |
Countries
Canada
Outcome results
None listed