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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:
Control:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: PI+FNB+IO | Experimental | Bupivicaine 15mg, Fentanyl 15mcg, Epimorphine 150mcg, 0.5% Ropivicaine with 1:400,000 Epinephrine 30ml, Ropivicaine 100ml, Epinephrine 600mcg, Ketorolac 30mg |
|
| Arm 2:NS+FNB+IO | Experimental | Bupivicaine 15mg, Fentanyl 15mcg, Epimorphine 150mcg, 0.5% Ropivicaine with1:400,000 Epinephrine 30ml, Normal Saline 100ml |
|
| Arm 3: PI+NS+IO | Experimental | Bupivicaine 15mg, Fentanyl 15mcg, Epimorphine 150mcg, Normal Saline 30ml, Ropivicaine 100ml, Epinephrine 600mcg, Ketorolac 30mg |
|
| Arm 4: PI+FNB+NS | Experimental | Bupivicaine 15mg, Fentanyl 15mcg, Normal Saline 0.3ml, 0.5% Ropivicaine with 1:400,000 Epinephrine 30ml, Ropivicaine 100ml, Epinephrine 600mcg, Ketorolac 30mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivicaine | Drug | 15mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Discharge | Meeting discharge criteria - Participants will be followed for the duration of hospital stay, approximately 3-5 days | Post-op day 1 to discharge date or day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Post-op day1 to discharge date or day 5 |
| Total Opioid Consumption Measures |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kim Wong, MD, FRCPC, BSc, PT | Health Sciences North | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health Sciences North Research Institute | Greater Sudbury | Ontario | P3E 5J1 | Canada |
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| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D000077330 | Saline Solution |
| D004837 | Epinephrine |
| D020910 | Ketorolac |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000077324 | Crystalloid Solutions |
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| Arm 5:NS+NS+IO | Active Comparator | Bupivicaine 15mg, Fentanyl 15mcg, Epimorphine 150mcg, Normal Saline 30ml, Normal Saline 100ml |
|
| Fentanyl | Drug | 15mcg |
|
| Epimorphine | Drug | 150mcg |
|
| Normal Saline | Drug | 0.3 ml |
|
| Normal Saline | Drug | 30ml |
|
| Normal Saline | Drug | 100 ml |
|
| Ropivicaine | Drug | 100 ml |
|
| Epinephrine | Drug | 600 mcg |
|
| Ketorolac | Drug | 30 mg |
|
| Ropivicaine with Epinephrine | Drug | 0.5% 1:400,000 30ml |
|
Narcotic Use and Assessment - Participants will be followed for the duration of hospital stay, approximately 3-5 days |
| 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 | Post-op day 0 to discharge date or day 5 |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |