The Combination of Adductor Canal Block and Periarticular Injection. A Novel Technique for Patients Undergoing Total Knee Replacement (ACB PAI)

Study Overview
=================
Brief Summary
-----------------
Total knee replacement is associated with severe post-operative pain. The purpose of this study is to compare two methods of treatment for pain control following Total Knee Replacement with an accelerated physical therapy protocol to aid the achievement of rehab milestones.

Detailed Description
-----------------
A total of 106 patients undergoing total knee arthroplasty will be randomized into two groups: one to receive only Periarticular injections and the other periarticular injections AND adductor canal block. Patients will be asked their numeric pain scores before surgery as baseline and at 24 and 48 hours post-operation. Patients also will be asked questions from painOUT questionnaire at 24 and 48 hours. Time to reach discharge criteria based on physical therapy assessments will also be measured.

Official Title
-----------------
The Combination of Adductor Canal Block and Periarticular Injection. A Novel Technique for Patients Undergoing Total Knee Replacement (ACB PAI)

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Drug: Bupivacaine
* Drug: Morphine
* Drug: Methylprednisolone
* Drug: Cefazolin
* Drug: Normal saline
* Drug: Midazolam
* Drug: Propofol
* Drug: Dexamethasone
* Device: 8 MHz. Chiba needle, 22 G / 4 inches


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with osteoarthritis scheduled for primary tricompartmental 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) Exclusion Criteria: Hepatic or renal insufficiency Patients younger than 18 years old and older than 80 Patients intending to receive general anesthesia Patients planning to go to rehab post operatively Patients scheduled to go into the OR after 1 pm Allergy or intolerance to one of the study medications Patients with an ASA of IV Chronic gabapentin/pregabalin use (regular use for longer than 3 months) Chronic opioid use (taking opioids for longer than 3 months) Diabetes Patients on workers compensation or disability

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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>Intra-Operatively Spinal anesthetic with 0.5% bupivacaine (10 or 12.5) Surgeon will perform the periarticular injections: First deep injection prior to cementation Bupivacaine 0.5% with epinephrine, 30cc Morphine, 8 mg/ml, 1 cc Methylprednisolone, 40 mg/ml, 1 ml Cefazolin, 500 mg in 10 ml Normal saline, 22cc Second superficial injection prior to closure. 1.20 ml 0.25% bupivacaine Intravenous sedation with midazolam and propofol. | Drug: Bupivacaine<br> <br> Drug: Morphine<br> <br> Drug: Methylprednisolone<br> <br> Drug: Cefazolin<br> <br> Drug: Normal saline<br> <br> Drug: Midazolam<br> <br> Drug: Propofol<br> <br> Drug: Dexamethasone<br> <br> |
| Experimental: Peri-Articular Injections and Adductor Canal Block<br>Intra-Operatively Spinal anesthetic with 0.5% bupivacaine (10 or 12.5) Adductor canal block technique: Supine position, after IV sedation Ultrasound guided with linear transducer 8 MHz. Chiba needle, 22 G / 4 inches Femoral artery will be identified in the adductor canal deep to the Sartorius muscle 15 cc of Bupivacaine 0.25% with 2 mg of Preservative free Dexamethasone Local anesthetic will be delivered periarterial between 12 and 6 o'clock Intravenous sedation with midazolam and propofol. First deep injection prior to cementation Bupivacaine 0.5% with epinephrine, 30cc Morphine, 8 mg/ml, 1 cc Methylprednisolone, 40 mg/ml, 1 ml Cefazolin, 500 mg in 10 ml Normal saline, 22cc Second superficial injection prior to closure. 20 ml 0.25% bupivacaine | Drug: Bupivacaine<br> <br> Drug: Morphine<br> <br> Drug: Methylprednisolone<br> <br> Drug: Cefazolin<br> <br> Drug: Normal saline<br> <br> Drug: Midazolam<br> <br> Drug: Propofol<br> <br> Drug: Dexamethasone<br> <br> Device: 8 MHz. Chiba needle, 22 G / 4 inches<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Meet Physical Therapy Discharge Criteria | Time to reach physical therapy (PT) goals | First 3 days post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical Rating Scale (NRS) Pain Scores With Ambulation Postoperative Day 1 | Patient reported pain scores on postoperative day 1 from 0-10. 0 being no pain, 10 being the worst pain imaginable. | 24 hours after operating room discharge | 
| NRS Pain Score With Movement POD2 | NRS pain with movement as reported by the patient. Rated from 0-10. 0 being no pain, 10 being the worst pain imaginable. | 48 hours after surgery | 
| Opioid Consumption Postoperative Day (POD) 1 | Opioid consumption for patients from 0-24 hours postoperative, measured in mg OME (oral morphine equivalents) | 0-24 hours postoperatively | 
| Opioid Consumption POD2 | Opioid consumption over hours 24-48 postoperatively. Measured in mg OME (oral morphine equivalents). Higher equates to more opioids consumed. | 24-48 hours postoperative | 
| Hospital Length of Stay | Measured in minutes. | Average of 3 days | 
| Patient Outcome Questionnaire (painOUT) Least Pain for 0-24 Hours Postoperatively | Measures: least pain in the last 24 hours. Scores are measured from 0-10. 0 being no pain to 10 being the worst pain imaginable. | Participants will be followed for the duration of 2 days post operatively in the hospital | 
| Patient Outcome Questionnaire (painOUT) Least Pain for 24-48 Hours Postoperatively | Least pain experienced from 24-48 hours postoperative on a scale from 0-10. 0 being no pain at all to 10 being the worst pain imaginable | 24-48 hours postoperative | 
| Patient Outcome Questionnaire (painOUT) Most Pain for 0-24 Hours Postoperatively | Painout most pain experienced 0-24 hours postoperatively, measured from 0-10. 0 being no pain to 10 being the worst pain imaginable | 0-24 hours postoperatively | 
| Patient Outcome Questionnaire (painOUT) Most Pain for 24-48 Hours Postoperatively | Painout most pain experienced 24-48 hours postoperatively measured on a scale from 0-10. Higher scores indicate higher pain levels. | 24-48 hours postoperative | 
| Knee Society Score (KSS) at 6 Weeks Postoperatively | KSS (Knee Society Score) score measured at 6 weeks postoperatively. The scale is from 0-100. Scores below 60 indicate poor function, 60-69 indicate fair, 70-79 indicate good, and 80-100 indicate excellent functional scores. KSS measures knee pain, flexion contracture,extension lag, alignment, stability, and total range of flexion and generates an associated score correlating to knee function. Higher is better. There is no sub score - only the cumulative Knee Society Score. | Post operatively at approximately 6 weeks after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nerve Block, Rehabilitation, Knee Replacement, Total