Liposomal Bupivacaine in Total Knee Arthroplasty

May 17, 2018 updated by: Morteza Meftah, Bronx-Lebanon Hospital Center Health Care System

Efficacy of Regional Adductor Canal Block Using Extended Release Liposomal Bupivacaine in Total Knee Arthroplasty: A Randomized Prospective Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • primary knee osteoarthritis undergoing unilateral knee replacement

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Difference in mean pain scores in the first 3 days after surgery
Time Frame: 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.
3 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Difference in mean opioid consumption in the first 3 days after surgery
Time Frame: 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.
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bronx-Lebanon Hospital Center Health Care System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 25, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 30, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 30, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 04141603

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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