Analgesia After Total Knee Arthroplasty: Peri-Articular Injection Versus Epidural + Femoral Nerve Blockade

Study Overview
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Brief Summary
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There are 2 common ways to manage pain after total knee arthroplasty at our institution. Some patients receive an epidural analgesia, a femoral nerve block and pills for pain. More recently, some surgeons have replaced femoral nerve blockade with peri-articular injections. These patients receive a peri-articular injection (injection of pain medication around the knee), pills for pain and a pain patch on the skin. The purpose of this research project is to find out if one of these ways to treat pain is better than the other. The investigators will look at this question in many ways, but the main way is how long it takes for you to be judged ready for discharge from the hospital.

Official Title
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Analgesia After Total Knee Arthroplasty: Peri-Articular Injection Versus Epidural + Femoral Nerve Blockade

Conditions
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Readiness to Discharge

Intervention / Treatment
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* Procedure: Peri-Articular Injection
* Procedure: Epidural Pathway (PCEA+FNB)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with osteoarthritis scheduled for primary bicompartmental total knee arthroplasty with a participating surgeon Age 18 to 85 years old Planned use of regional anesthesia Ability to follow study protocol Up to 15 degrees varus, up to 15 degrees flexion and up to 15 degrees valgus Exclusion Criteria: Patients younger than 18 years old and older than 85 Patients intending to receive general anesthesia Allergy or intolerance to one of the study medications Patients with an ASA of IV Patients with insulin-dependent diabetes Patients with hepatic (liver) failure Patients with chronic renal (kidney) failure Chronic opioid use (taking opioids for longer than 3 months) Patients with any prior major ipsilateral open knee surgery. Patients with flexion contracture of knee > 15 degrees Patients with varus deformity > 15 degrees Patients with valgus deformity > 15 degrees Patients with a contraindication to use of epinephrine

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Epidural Pathway (PCEA+FNB)<br> | Procedure: Epidural Pathway (PCEA+FNB)<br>* Pre-operative anesthesia/analgesia: meloxicam (7.5 or 15mg), extended release oxycodone (10mg or 20mg), dexamethasone (6mg), clonidine patch (100 mcg/24 hr) Anesthetic: Spinal with 0.5% bupivacaine, IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Post-operative analgesia:Prilosec (20mg), Meloxicam (7.5mg or 15 mg PO), extended release oxycodone (10mg or 20mg), Oxycodone (5mg q 3 hr PRN), Acetaminophen (1000mg), ketorolac 15mg IV<br>|
| Active Comparator: Peri-Articular Injection<br> | Procedure: Peri-Articular Injection<br>* Pre-operative anesthesia/analgesia: meloxicam (7.5 or 15mg), dexamethasone (6mg) Anesthetic:: Combined Spinal-Epidural with 0.5% bupivacaine. IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Postoperative pain management: hydromorphone/bupivacaine PCEA (4/4/10/20, initially). Meloxicam (7.5 or 15mg), Oxycodone/Acetaminophen (5/325 3hr PRN)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Primary Outcome is Time Until a Patient is Ready for Discharge. | The primary outcome is time until a patient is ready for discharge. Discharge criteria are: PCA (if present) has been discontinued Not experiencing moderate or severe nausea (within last 4 hours). Solid food diet Able to urinate (Foley catheter removed) Pain: NRS <4. Surgical wound dry No acute medical problems Physical Therapy Criteria Independently transfer from supine to sit, from sitting to standing Ambulate 40 ft. without assistance Extension range of motion (< 10 degrees) | Participants will be followed for the duration of their hospital stay, an expected average of 3 days |