Liposomal Bupivacaine in Total Knee Arthroplasty

NCT03541265 | Completed

• 1 other identifier: 04141603
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Knee Osteoarthritis; Anesthesia, Local

Keywords

liposomal bupivacaine; total knee arthroplasty

Outcome Measures

Primary Outcomes (1)

• Difference in mean pain scores in the first 3 days after surgery

  Pain was recorded during the first 3 post-operative days after surgery on scale 0 to 10 (visual analog scale). Zero represents 'no pain', as the best outcome and 10 represents as 'the worst pain experienced' as the worst outcome.The difference between the mean pain score in the two groups is assessed.

  3 days

Secondary Outcomes (1)

• Difference in mean opioid consumption in the first 3 days after surgery

  3 days

Study Arms (2)

Adductor block protocol

EXPERIMENTAL

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.

Drug: Exparel; Procedure: Adductor block protocol

peri-articular injection

ACTIVE COMPARATOR

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.

Drug: Exparel; Procedure: peri-articular injection protocol

Interventions

Exparel DRUG

long-acting Bupivacaine extended release liposome compound

Also known as: Liposomal Bupivacaine

Adductor block protocol; peri-articular injection

Adductor block protocol PROCEDURE

Adductor block using Exparel

Adductor block protocol

peri-articular injection protocol PROCEDURE

peri-articular injection using Exparel

peri-articular injection

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• primary knee osteoarthritis undergoing unilateral knee replacement

You may not qualify if:

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

Sponsors & Collaborators

• Bronx-Lebanon Hospital Center Health Care System: lead

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Adult Recosntruction Orthopaedic Surgery

Model Details: This is a a randomized prospective study. Patients were assigned into two cohorts on the day of surgery using a randomization software by an independent observer. Randomization was based on age, gender, BMI and type of surgery. The investigators hypothesized that there would be no difference in the pain scores or morphine consumption. Sample size analysis for a randomized prospective trial was performed to achieve an 80% power to detect 20% difference in pain scores (2-point score difference on VAS 0-10 was deemed clinically relevant). A sealed envelope was given to the anesthesiologist and the surgeon on the day of surgery, stating the group that the patient was assigned to participate. All descriptive statistics (Mean, SD) and analysis were performed with SPSS version 21 (IBM) at a 0.05 level of significance.

Study Record Dates

• First Submitted: April 25, 2018
• First Posted: May 30, 2018
• Study Start: May 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: March 1, 2018
• Last Updated: May 30, 2018

Record last verified: 2018-05