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

Sponsor

Hospital for Special Surgery, New York (Other)

Overall Status

Unknown status

CT.gov ID

NCT03094663

Collaborator

(none)

Enrollment

Location

Arms

23.1

Anticipated Duration (Months)

3.7

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Knee Arthropathy	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	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

86 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 28, 2017

Actual Primary Completion Date :

May 31, 2018

Anticipated Study Completion Date :

Jan 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Peri-Articular Injections only 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 0.5% with epinephrine 30cc Drug: Methylprednisolone 40 mg/ml, 1 ml Drug: Cefazolin 500 mg in 10 ml Device: 8 MHz. Chiba needle 22G/ 4 inches Drug: 25 cc 0.25% bupivacaine 25 cc 0.25% bupivacaine Drug: 20cc 0.25% bupivacaine 20cc 0.25% bupivacaine Drug: 2 mg IV dexamethasone. 2 mg IV dexamethasone. Drug: bupivacaine 0.5% with epinephrine 30cc bupivacaine 0.5% with epinephrine 30cc
Experimental: Peri-Articular Injections, Adductor Canal Block, and IPACK 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 0.5% with epinephrine 30cc Drug: Methylprednisolone 40 mg/ml, 1 ml Drug: Cefazolin 500 mg in 10 ml Device: 8 MHz. Chiba needle 22G/ 4 inches Drug: 15 cc of bupivacaine 0.25% with 2 mg of preservative free Dexamethasone 15 cc of bupivacaine 0.25% with 2 mg of PF Dexamethasone Drug: 25 cc 0.25% bupivacaine 25 cc 0.25% bupivacaine Drug: 20cc 0.25% bupivacaine 20cc 0.25% bupivacaine

Arm

Intervention/Treatment

Active Comparator: Peri-Articular Injections only

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

0.5% with epinephrine 30cc

Drug: Methylprednisolone

40 mg/ml, 1 ml

Drug: Cefazolin

500 mg in 10 ml

Device: 8 MHz. Chiba needle

22G/ 4 inches

Drug: 25 cc 0.25% bupivacaine

25 cc 0.25% bupivacaine

Drug: 20cc 0.25% bupivacaine

20cc 0.25% bupivacaine

Drug: 2 mg IV dexamethasone.

2 mg IV dexamethasone.

Drug: bupivacaine 0.5% with epinephrine 30cc

bupivacaine 0.5% with epinephrine 30cc

Experimental: Peri-Articular Injections, Adductor Canal Block, and IPACK

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

0.5% with epinephrine 30cc

Drug: Methylprednisolone

40 mg/ml, 1 ml

Drug: Cefazolin

500 mg in 10 ml

Device: 8 MHz. Chiba needle

22G/ 4 inches

Drug: 15 cc of bupivacaine 0.25% with 2 mg of preservative free Dexamethasone

15 cc of bupivacaine 0.25% with 2 mg of PF Dexamethasone

Drug: 25 cc 0.25% bupivacaine

25 cc 0.25% bupivacaine

Drug: 20cc 0.25% bupivacaine

20cc 0.25% bupivacaine

Outcome Measures

Primary Outcome Measures

NRS Pain Scores [24 hours post block administration]
NRS Pain scores with ambulation 24 hours post block administration

Secondary Outcome Measures

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
NRS 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]
NRS at rest and with movement at different intervals
Physical Therapy milestones [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]
Milestones include time to ambulate and time to reach discharge criteria set by Physical Therapy
Patient Satisfaction with Pain Control using the likert scale [Post-Operative Day 2]
Satisfaction with Pain control at different intervals
PainOUT [Post-Operative Day 1 and Post-Operative Day 2]
PainOUT scores
Hospital Length of Stay [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]
Length of Stay (LOS) calculation
Opioid Related Symptom Distress Scale (ORSDS) [Post-Operative Day 1 and Post-Operative Day 2]
ORSDS scores
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr) [baseline and 6 weeks post op]
KOOS Jr scores

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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