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Liposomal Bupivacaine in Total Knee Arthroplasty

Sponsor
Bronx-Lebanon Hospital Center Health Care System (Other)
Overall Status
Completed
CT.gov ID
NCT03541265
Collaborator
(none)
70
Enrollment
2
Arms
22
Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Exparel
  • Procedure: Adductor block protocol
  • Procedure: peri-articular injection protocol
 N/A

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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.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.
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Efficacy of Regional Adductor Canal Block Using Extended Release Liposomal Bupivacaine in Total Knee Arthroplasty: A Randomized Prospective Study
Actual Study Start Date :
May 1, 2016
Actual Primary Completion Date :
Jun 1, 2017
Actual Study Completion Date :
Mar 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Adductor block protocol

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
long-acting Bupivacaine extended release liposome compound
Other Names:
  • Liposomal Bupivacaine

    • Procedure: Adductor block protocol
    Adductor block using Exparel
    Active Comparator: peri-articular injection

    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
    long-acting Bupivacaine extended release liposome compound
    Other Names:
  • Liposomal Bupivacaine

    • Procedure: peri-articular injection protocol
    peri-articular injection using Exparel

    Outcome Measures

    Primary Outcome Measures

    1. Difference in mean pain scores in the first 3 days after surgery [3 days]

      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.

    Secondary Outcome Measures

    1. Difference in mean opioid consumption in the first 3 days after surgery [3 days]

      All opioids were converted to Morphine equivalent consumption (MEC) during the first 3 days. The difference in the mean MEC in the two groups is assessed.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • primary knee osteoarthritis undergoing unilateral knee replacement
    Exclusion Criteria:
    • hypersensitivity and/or allergies to local anesthetics or previous knee surgery

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Bronx-Lebanon Hospital Center Health Care System

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Morteza Meftah, Chief, Adult Recosntruction Orthopaedic Surgery, Bronx-Lebanon Hospital Center Health Care System
    ClinicalTrials.gov Identifier:
    NCT03541265
    Other Study ID Numbers:
    • 04141603
    First Posted:
    May 30, 2018
    Last Update Posted:
    May 30, 2018
    Last Verified:
    May 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Morteza Meftah, Chief, Adult Recosntruction Orthopaedic Surgery, Bronx-Lebanon Hospital Center Health Care System
    liposomal bupivacaine
    total knee arthroplasty
    Additional relevant MeSH terms:
    Osteoarthritis
    Osteoarthritis, Knee
    Bupivacaine

    Study Results

    No Results Posted as of May 30, 2018