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

Hospital for Special Surgery (HSS)

Status and phase: Completed; Phase 4

Conditions: Osteoarthritis

Treatments: Drug: Bupivacaine; Drug: Propofol; Drug: Morphine; Device: 8 MHz. Chiba needle, 22 G / 4 inches; Drug: Normal saline; Drug: Midazolam; Drug: Cefazolin; Drug: Methylprednisolone; Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT02292082

2014-018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 111 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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111 participants in 2 patient groups

Peri-Articular Injections only

Active Comparator group

Description:

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.

Treatment:

Drug: Methylprednisolone

Drug: Propofol

Drug: Morphine

Drug: Bupivacaine

Drug: Normal saline

Drug: Dexamethasone

Drug: Midazolam

Drug: Cefazolin

Peri-Articular Injections and Adductor Canal Block

Experimental group

Description:

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

Treatment:

Device: 8 MHz. Chiba needle, 22 G / 4 inches

Drug: Methylprednisolone

Drug: Propofol

Drug: Morphine

Drug: Bupivacaine

Drug: Normal saline

Drug: Dexamethasone

Drug: Midazolam

Drug: Cefazolin