Implementation of a Pain Management Protocol for Total Knee Arthroplasty

Study Overview
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Brief Summary
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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)?

Detailed Description
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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.

Official Title
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An Analysis of the Functional Benefit, Narcotic Use and Time to Discharge Readiness Following the Implementation of a Comprehensive Pain Management Protocol for Primary Total Knee Arthroplasty

Conditions
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Knee Replacement, Total

Intervention / Treatment
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* Drug: Bupivicaine
* Drug: Fentanyl
* Drug: Epimorphine
* Drug: Normal Saline
* Drug: Normal Saline
* Drug: Normal Saline
* Drug: Ropivicaine
* Drug: Epinephrine
* Drug: Ketorolac
* Drug: Ropivicaine with Epinephrine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: PI+FNB+IO<br>Bupivicaine 15mg, Fentanyl 15mcg, Epimorphine 150mcg, 0.5% Ropivicaine with 1:400,000 Epinephrine 30ml, Ropivicaine 100ml, Epinephrine 600mcg, Ketorolac 30mg | Drug: Bupivicaine<br>* 15mg<br>Drug: Fentanyl<br>* 15mcg<br>Drug: Epimorphine<br>* 150mcg<br>Drug: Ropivicaine<br>* 100 ml<br>Drug: Epinephrine<br>* 600 mcg<br>Drug: Ketorolac<br>* 30 mg<br>Drug: Ropivicaine with Epinephrine<br>* 0.5% 1:400,000 30ml<br>|
| Experimental: Arm 2:NS+FNB+IO<br>Bupivicaine 15mg, Fentanyl 15mcg, Epimorphine 150mcg, 0.5% Ropivicaine with1:400,000 Epinephrine 30ml, Normal Saline 100ml | Drug: Bupivicaine<br>* 15mg<br>Drug: Fentanyl<br>* 15mcg<br>Drug: Epimorphine<br>* 150mcg<br>Drug: Normal Saline<br>* 100 ml<br>Drug: Ropivicaine with Epinephrine<br>* 0.5% 1:400,000 30ml<br>|
| Experimental: Arm 3: PI+NS+IO<br>Bupivicaine 15mg, Fentanyl 15mcg, Epimorphine 150mcg, Normal Saline 30ml, Ropivicaine 100ml, Epinephrine 600mcg, Ketorolac 30mg | Drug: Bupivicaine<br>* 15mg<br>Drug: Fentanyl<br>* 15mcg<br>Drug: Epimorphine<br>* 150mcg<br>Drug: Normal Saline<br>* 30ml<br>Drug: Ropivicaine<br>* 100 ml<br>Drug: Epinephrine<br>* 600 mcg<br>Drug: Ketorolac<br>* 30 mg<br>|
| Experimental: Arm 4: PI+FNB+NS<br>Bupivicaine 15mg, Fentanyl 15mcg, Normal Saline 0.3ml, 0.5% Ropivicaine with 1:400,000 Epinephrine 30ml, Ropivicaine 100ml, Epinephrine 600mcg, Ketorolac 30mg | Drug: Bupivicaine<br>* 15mg<br>Drug: Fentanyl<br>* 15mcg<br>Drug: Normal Saline<br>* 0.3 ml<br>Drug: Ropivicaine<br>* 100 ml<br>Drug: Epinephrine<br>* 600 mcg<br>Drug: Ketorolac<br>* 30 mg<br>Drug: Ropivicaine with Epinephrine<br>* 0.5% 1:400,000 30ml<br>|
| Active Comparator: Arm 5:NS+NS+IO<br>Bupivicaine 15mg, Fentanyl 15mcg, Epimorphine 150mcg, Normal Saline 30ml, Normal Saline 100ml | Drug: Bupivicaine<br>* 15mg<br>Drug: Fentanyl<br>* 15mcg<br>Drug: Epimorphine<br>* 150mcg<br>Drug: Normal Saline<br>* 30ml<br>Drug: Normal Saline<br>* 100 ml<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |