Adductor Canal Block With Periarticular Injection and IPACK (ACB/PAI/IPACK) Versus Periarticular Injection (PAI)

Study Overview
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Brief Summary
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A comparison of two pain control methods - the combination of Adductor Canal Block (ACB)/Periarticular Injection (PAI)/Infiltration of the interspace between the popliteal artery and the capsule of the posterior knee (IPACK) versus the Periarticular Injection (PAI) - in patients undergoing total knee arthroplasty. Primary outcome is NRS pain scores with ambulation on postoperative day one (24 hours post-block administration).

Official Title
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Analgesia After Total Knee Arthroplasty: Adductor Canal Block With Periarticular Injection and IPACK (ACB/PAI/IPACK) Versus Periarticular Injection (PAI). A Double-Blinded Randomized Controlled Trial

Conditions
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Knee Arthropathy

Intervention / Treatment
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* Drug: Bupivacaine
* Drug: Methylprednisolone
* Drug: Cefazolin
* Device: 8 MHz. Chiba needle
* Drug: 15 cc of bupivacaine 0.25% with 2 mg of preservative free Dexamethasone
* Drug: 25 cc 0.25% bupivacaine
* Drug: 20cc 0.25% bupivacaine
* Drug: 2 mg IV dexamethasone.
* Drug: bupivacaine 0.5% with epinephrine 30cc


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with osteoarthritis scheduled for a primary either partial or total knee arthroplasty with a participating surgeon Age 18 to 80 years Planned use of regional anesthesia Ability to follow study protocol English speaking (secondary outcomes include questionnaires validated in English only) Patients of participating surgeons Exclusion Criteria: Hepatic or renal insufficiency Younger than 18 years old and older than 80 Patients undergoing general anesthesia Allergy or intolerance to one of the study medications BMI > 40 Diabetes ASA of IV Chronic gabapentin/pregabalin use (regular use for longer than 3 months) Chronic opioid use (taking opioids for longer than 3 months, or daily oral morphine equivalent of >5mg/day for one month) Patients with severe valgus deformity and flexion contracture

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Peri-Articular Injections only<br>Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg) Injection prior to cementation bupivacaine 0.5% with epinephrine 30cc; methylprednisolone, 40 mg/ml, 1 ml cefazolin, 500 mg in 10 ml normal saline, 22cc Superficial injection prior to closure. 20cc 0.25% bupivacaine 2 mg IV dexamethasone. | Drug: Bupivacaine<br>* 0.5% with epinephrine 30cc<br>Drug: Methylprednisolone<br>* 40 mg/ml, 1 ml<br>Drug: Cefazolin<br>* 500 mg in 10 ml<br>Device: 8 MHz. Chiba needle<br>* 22G/ 4 inches<br>Drug: 25 cc 0.25% bupivacaine<br>* 25 cc 0.25% bupivacaine<br>Drug: 20cc 0.25% bupivacaine<br>* 20cc 0.25% bupivacaine<br>Drug: 2 mg IV dexamethasone.<br>* 2 mg IV dexamethasone.<br>Drug: bupivacaine 0.5% with epinephrine 30cc<br>* bupivacaine 0.5% with epinephrine 30cc<br>|
| Experimental: Peri-Articular Injections, Adductor Canal Block, and IPACK<br>Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg) Injection prior to cementation bupivacaine 0.25% with epinephrine 30cc; methylprednisolone, 40 mg/ml, 1 ml cefazolin, 500 mg in 10 ml normal saline, 22cc Superficial injection prior to closure. a. 20cc 0.25% bupivacaine Adductor canal block technique (supine position, post IV sedation) a. Mid-thigh injection of 15 cc of bupivacaine 0.25% with 2 mg of PF Dexamethasone IPACK technique (supine position) a. 25 cc 0.25% bupivacaine | Drug: Bupivacaine<br>* 0.5% with epinephrine 30cc<br>Drug: Methylprednisolone<br>* 40 mg/ml, 1 ml<br>Drug: Cefazolin<br>* 500 mg in 10 ml<br>Device: 8 MHz. Chiba needle<br>* 22G/ 4 inches<br>Drug: 15 cc of bupivacaine 0.25% with 2 mg of preservative free Dexamethasone<br>* 15 cc of bupivacaine 0.25% with 2 mg of PF Dexamethasone<br>Drug: 25 cc 0.25% bupivacaine<br>* 25 cc 0.25% bupivacaine<br>Drug: 20cc 0.25% bupivacaine<br>* 20cc 0.25% bupivacaine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NRS Pain Scores | NRS Pain scores with ambulation 24 hours post block administration | 24 hours post block administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid consumption | Opioid consumption at different intervals | 24 hours on Post-Operative Day 1, 48 hours on Post-Operative Day 2, and 72 hours on Post-Operative Day 3 | 
| NRS at Rest and with movement | NRS at rest and with movement at different intervals | 24 hours on Post-Operative Day 1, 48 hours on Post-Operative Day 2, and 72 hours on Post-Operative Day 3 | 
| Physical Therapy milestones | Milestones include time to ambulate and time to reach discharge criteria set by Physical Therapy | It will be assessed on 24 hours on Post-Operative Day 1, 48 hours on Post-Operative Day 2, and 72 hours on Post-Operative Day 3 | 
| Patient Satisfaction with Pain Control using the likert scale | Satisfaction with Pain control at different intervals | Post-Operative Day 2 | 
| PainOUT | PainOUT scores | Post-Operative Day 1 and Post-Operative Day 2 | 
| Hospital Length of Stay | Length of Stay (LOS) calculation | It will be assessed on 24 hours on Post-Operative Day 1, 48 hours on Post-Operative Day 2, and 72 hours on Post-Operative Day 3 | 
| Opioid Related Symptom Distress Scale (ORSDS) | ORSDS scores | Post-Operative Day 1 and Post-Operative Day 2 | 
| Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr) | KOOS Jr scores | baseline and 6 weeks post op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IPACK, PAI