Liposomal Bupivacaine in Total Knee Arthroplasty

Bronx-Lebanon Hospital Center Health Care System

Status: Completed

Conditions: Anesthesia, Local; Knee Osteoarthritis

Treatments: Procedure: peri-articular injection protocol; Procedure: Adductor block protocol; Drug: Exparel

Study type: Interventional

Funder types: Other

Identifiers

NCT03541265

04141603

Details and patient eligibility

About

Pain management after total knee arthroplasty is essential for optimized clinical outcomes and higher satisfaction. Exparel (Pacira Pharmaceuticals, Parsippany, New Jersey, USA) is a long-acting Bupivacaine extended release liposome compound that is injected peri-articularly or as regional block. The purpose of this study was to compare the analgesic efficacy of single administration of Exparel for local peri-articular infiltration versus adductor canal regional block.

Full description

Multimodal pain approach is now an accepted standard of care to improve pain, enable earlier mobilization and faster recovery, decreased length of stay, and reduce opioid consumption and related side effects. The multimodal approach includes peri-operative oral and IV analgesics, local periarticular injections (PAI), and/or regional blocks such as femoral nerve blocks nerve or subsartorial saphenous nerve (adductor canal) blocks. Extended release bupivacaine (Exparel - Pacira Pharmaceuticals, Parsippany, NJ, USA) in liposomal form was developed for longer lasting post-operative analgesia. There are limited studies analyzing its efficacy of single injection liposomal bupivacaine in adductor canal block in total knee arthroplasty. The investigators hypothesized that a single adductor canal regional block injection would provide similar pain relief as peri-articular infiltration of Exparel.

Enrollment: 70 patients

Sex: All

Ages: 25+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• primary knee osteoarthritis undergoing unilateral knee replacement

Exclusion criteria

• hypersensitivity and/or allergies to local anesthetics or previous knee surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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70 participants in 2 patient groups

Adductor block protocol

Experimental group

Description:

An ultrasound-guided injection of Subsartorial saphenous nerve using Exparel 266 mg (20 cc vial) via a 21-gauge 4-inch Stimuplex A needle (B. Braun Medical Inc., Melsungen, Germany) was performed at mid-thigh level with a high-frequency linear ultrasound transducer. All regional anesthesia was performed by a trained anesthesiologist. Ultrasound pictures (pre-injection and post-injection) was obtained to verify proper local anesthetic placement.

Treatment:

Drug: Exparel

Procedure: Adductor block protocol

peri-articular injection

Active Comparator group

Description:

Peri-articular injection included combination of Exparel 266 mg (20 ml vial) with 20 ml of 0.5% bupivacaine, and normal saline to a total volume of 120 ml. The injection was meticulously administered prior and after cementation in the posterior capsule, posteromedial structures, the periarticular synovium, extensor apparatus, pes anserinus, anteromedial capsule, periosteum, iliotibial band, and subcutaneous plane. Injections were performed using 20-mL syringes with 22-gauge needle, minimal leakage. Visible tissue expansion was achieved.

Treatment:

Procedure: peri-articular injection protocol

Drug: Exparel