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

Phase 4

Completed

Conditions: Knee Arthropathy

Interventions: Drug: Bupivacaine with epinephrine
Drug: Methylprednisolone
Drug: Cefazolin
Device: 8 MHz. Chiba needle
Drug: Bupivacaine with Dexamethasone
Drug: Bupivacaine 25cc
Drug: Bupivacaine 20cc
Drug: Dexamethasone

Registration Number: NCT03094663

Lead Sponsor: Hospital for Special Surgery, New York

Brief Summary: 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).

Detailed Description: Total knee arthroplasties (TKA) are severely painful surgeries that require optimal pain control to ensure expeditious recovery and discharge. Nerve blocks, such as the femoral and sciatic nerves, are instrumental in effectively providing pain relief and improving patient satisfaction. However, though pain scores notably decreased with the introduction of nerve blocks, motor blockade rendered these patients immobile and may pose a fall risk early in the post-operative period. The advent of ultrasound introduces newer block techniques with adequate analgesia without the cost of motor blockade.

The adductor canal block serves as an alternative to the femoral or sciatic nerve blocks in providing anterior knee analgesia without significantly compromising quadriceps strength. However, patients' posterior knee compartment remains an issue for pain control. Sciatic and posterior tibial nerve blocks were implemented but again, results in motor blockade. A small percentage of sciatic nerve block cases also exhibit foot drop due to peroneal nerve injury. Alternatively, as a sensory block, the periarticular injection (PAI) proves to hasten ambulation and recovery after TKA. The PAI blind injection into the posterior capsule seems to aid in pain control of the posterior compartment and reduces the total number physical therapy sessions.

Injection in the interspace between the Popliteal Artery and Capsule of the posterior Knee (IPACK) provides an alternative to the PAI blind technique for analgesia in the posterior compartment. The IPACK block is not a nerve block, but rather infiltrates the area between the popliteal artery and femur. This area is rich with sensory nerve fibers from the posterior capsule of the knee, which originates from the sciatic and posterior tibial nerve. In this prospective study, we will compare pain scores between the three groups: ACB/PAI/IPACK, ACB/IPACK and PAI only. We will determine whether there is a difference between groups in NRS pain score with ambulation 24 hours post block administration.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 86

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Peri-Articular Injections only	8 MHz. Chiba needle	Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg) 1. Injection prior to cementation 1. bupivacaine 0.5% with epinephrine 30cc; 2. methylprednisolone, 40 mg/ml, 1 ml 3. cefazolin, 500 mg in 10 ml 4. normal saline, 22cc 2. Superficial injection prior to closure. 1. 20cc 0.25% bupivacaine 2. 2 mg IV dexamethasone.
Peri-Articular Injections, Adductor Canal Block, and IPACK	8 MHz. Chiba needle	Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg) 1. Injection prior to cementation 1. bupivacaine 0.25% with epinephrine 30cc; 2. methylprednisolone, 40 mg/ml, 1 ml 3. cefazolin, 500 mg in 10 ml 4. normal saline, 22cc 2. Superficial injection prior to closure. a. 20cc 0.25% bupivacaine 3. 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 4. IPACK technique (supine position) a. 25 cc 0.25% bupivacaine
Peri-Articular Injections, Adductor Canal Block, and IPACK	Bupivacaine 20cc	Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg) 1. Injection prior to cementation 1. bupivacaine 0.25% with epinephrine 30cc; 2. methylprednisolone, 40 mg/ml, 1 ml 3. cefazolin, 500 mg in 10 ml 4. normal saline, 22cc 2. Superficial injection prior to closure. a. 20cc 0.25% bupivacaine 3. 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 4. IPACK technique (supine position) a. 25 cc 0.25% bupivacaine
Peri-Articular Injections only	Bupivacaine with epinephrine	Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg) 1. Injection prior to cementation 1. bupivacaine 0.5% with epinephrine 30cc; 2. methylprednisolone, 40 mg/ml, 1 ml 3. cefazolin, 500 mg in 10 ml 4. normal saline, 22cc 2. Superficial injection prior to closure. 1. 20cc 0.25% bupivacaine 2. 2 mg IV dexamethasone.
Peri-Articular Injections, Adductor Canal Block, and IPACK	Bupivacaine with epinephrine	Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg) 1. Injection prior to cementation 1. bupivacaine 0.25% with epinephrine 30cc; 2. methylprednisolone, 40 mg/ml, 1 ml 3. cefazolin, 500 mg in 10 ml 4. normal saline, 22cc 2. Superficial injection prior to closure. a. 20cc 0.25% bupivacaine 3. 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 4. IPACK technique (supine position) a. 25 cc 0.25% bupivacaine
Peri-Articular Injections, Adductor Canal Block, and IPACK	Bupivacaine with Dexamethasone	Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg) 1. Injection prior to cementation 1. bupivacaine 0.25% with epinephrine 30cc; 2. methylprednisolone, 40 mg/ml, 1 ml 3. cefazolin, 500 mg in 10 ml 4. normal saline, 22cc 2. Superficial injection prior to closure. a. 20cc 0.25% bupivacaine 3. 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 4. IPACK technique (supine position) a. 25 cc 0.25% bupivacaine
Peri-Articular Injections only	Bupivacaine 25cc	Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg) 1. Injection prior to cementation 1. bupivacaine 0.5% with epinephrine 30cc; 2. methylprednisolone, 40 mg/ml, 1 ml 3. cefazolin, 500 mg in 10 ml 4. normal saline, 22cc 2. Superficial injection prior to closure. 1. 20cc 0.25% bupivacaine 2. 2 mg IV dexamethasone.
Peri-Articular Injections only	Bupivacaine 20cc	Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg) 1. Injection prior to cementation 1. bupivacaine 0.5% with epinephrine 30cc; 2. methylprednisolone, 40 mg/ml, 1 ml 3. cefazolin, 500 mg in 10 ml 4. normal saline, 22cc 2. Superficial injection prior to closure. 1. 20cc 0.25% bupivacaine 2. 2 mg IV dexamethasone.
Peri-Articular Injections, Adductor Canal Block, and IPACK	Bupivacaine 25cc	Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg) 1. Injection prior to cementation 1. bupivacaine 0.25% with epinephrine 30cc; 2. methylprednisolone, 40 mg/ml, 1 ml 3. cefazolin, 500 mg in 10 ml 4. normal saline, 22cc 2. Superficial injection prior to closure. a. 20cc 0.25% bupivacaine 3. 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 4. IPACK technique (supine position) a. 25 cc 0.25% bupivacaine
Peri-Articular Injections only	Methylprednisolone	Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg) 1. Injection prior to cementation 1. bupivacaine 0.5% with epinephrine 30cc; 2. methylprednisolone, 40 mg/ml, 1 ml 3. cefazolin, 500 mg in 10 ml 4. normal saline, 22cc 2. Superficial injection prior to closure. 1. 20cc 0.25% bupivacaine 2. 2 mg IV dexamethasone.
Peri-Articular Injections only	Cefazolin	Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg) 1. Injection prior to cementation 1. bupivacaine 0.5% with epinephrine 30cc; 2. methylprednisolone, 40 mg/ml, 1 ml 3. cefazolin, 500 mg in 10 ml 4. normal saline, 22cc 2. Superficial injection prior to closure. 1. 20cc 0.25% bupivacaine 2. 2 mg IV dexamethasone.
Peri-Articular Injections only	Dexamethasone	Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg) 1. Injection prior to cementation 1. bupivacaine 0.5% with epinephrine 30cc; 2. methylprednisolone, 40 mg/ml, 1 ml 3. cefazolin, 500 mg in 10 ml 4. normal saline, 22cc 2. Superficial injection prior to closure. 1. 20cc 0.25% bupivacaine 2. 2 mg IV dexamethasone.
Peri-Articular Injections, Adductor Canal Block, and IPACK	Cefazolin	Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg) 1. Injection prior to cementation 1. bupivacaine 0.25% with epinephrine 30cc; 2. methylprednisolone, 40 mg/ml, 1 ml 3. cefazolin, 500 mg in 10 ml 4. normal saline, 22cc 2. Superficial injection prior to closure. a. 20cc 0.25% bupivacaine 3. 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 4. IPACK technique (supine position) a. 25 cc 0.25% bupivacaine
Peri-Articular Injections, Adductor Canal Block, and IPACK	Methylprednisolone	Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg) 1. Injection prior to cementation 1. bupivacaine 0.25% with epinephrine 30cc; 2. methylprednisolone, 40 mg/ml, 1 ml 3. cefazolin, 500 mg in 10 ml 4. normal saline, 22cc 2. Superficial injection prior to closure. a. 20cc 0.25% bupivacaine 3. 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 4. IPACK technique (supine position) a. 25 cc 0.25% bupivacaine

Primary Outcome Measures

Name	Time	Method
Numeric Rating Scale (NRS) Pain Scores	24 hours post block administration	Numeric Rating Scale (NRS) Pain scores with ambulation 24 hours post block administration. Min = 0, no pain Max = 10, worst imaginable pain

Secondary Outcome Measures

Name	Time	Method
Numeric Rating Scale (NRS) Pain Scores at Rest and With Movement	24 hours on Post-Operative Day 1, 48 hours on Post-Operative Day 2, and 72 hours on Post-Operative Day 3	Numeric Rating Scale (NRS) Pain scores at rest and with movement at different intervals Min = 0, no pain Max = 10, worst imaginable pain Despite being collected at various times, the average pain score across all time points was calculated and reported.
Opioid Consumption	24 hours on Post-Operative Day 1, 48 hours on Post-Operative Day 2, and 72 hours on Post-Operative Day 3	Opioid consumption at different intervals. Although collected at different time points, the average amount of opioid across all the time points was calculated and reported.
Ambulation Distance During 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	The distance patients were able to walked during physical therapy ambulation. Measured in feet. The average distance that patients walked at each time point was calculated and reported for the number of participants analyzed.
Level of Patient Satisfaction With Postoperative Pain Management	Post-Operative Day 2	Patient satisfaction with their postoperative pain management. Measured on a scale of 0 to 10, with 0 meaning extremely dissatisfied and 10 meaning extremely satisfied.
Pain Outcomes	Post-Operative Day 1 and Post-Operative Day 2, average across the two time points reported	The Pain Outcomes (PainOUT) questionnaire was used to assess postoperative pain, psychological variables associated with pain, opioid consumption, satisfaction, and side effects. Scored on 3 scales of 0 to 10, depending on each individual question: 0 = no pain, 10 = worst pain imaginable 0 = did not interfere, 10 = completely interfered 0 = not at all, 10 = extremely Although measured across different timepoints, the average score of all participants was calculated and reported.
Hospital Length of Stay	Assessed at either: 24 hours on Post-Operative Day 1, 48 hours on Post-Operative Day 2, or 72 hours on Post-Operative Day 3	The patients' Length of Stay (LOS) at the hospital will be calculate with the time the patient entered the post-operative care unit being the "begin time" and the time patient was discharged being the "end time." The "end time" will differ for each patient depending on which day (post-operative day 1, post-operative day 2, or post-operative day 3) they were discharged. The average length of stay for all patients (reported in minutes) will be reported.
Opioid Related Symptom Distress Scale (ORSDS)	Post-Operative Day 1 and Post-Operative Day 2	ORSDS scores. A lower score is a better outcome. range is 0 to 4.
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr)	Measured at pre-operation (day of surgery) and 6 weeks post-operation	This is a patient-reported joint-specific score used to assess outcomes following total knee arthroplasty. Scores range from 0 to 100, with 0 representing total knee disability and 100 representing perfect knee health. Higher score means better outcome. The average score for each time point is reported for each arm.