Exparel vs Block for ACL Reconstruction

June 19, 2024 updated by: Rothman Institute Orthopaedics

Single-Shot Liposomal Bupivacaine vs. Liposomal Bupivacaine Combined With Dexamethasone Following Anterior Cruciate Ligament Reconstruction: A Prospective Randomized Controlled Trial

Liposomal bupivacaine or Exparel (Pacira Biosciences) is a long-lasting nonopioid analgesic that was initially utilized as an infiltrative agent but has more recently become U.S. Food and Drug Administration (FDA) approved for use in interscalene brachial plexus nerve blockade as well as infiltrative blockade. Delivery in this form is reported to provide up to 72 hours of extended-release bupivacaine. Exparel's use as a regional anesthetic has also become increasingly common and has shown promise when utilized in Anterior Cruciate Ligament (ACL) reconstruction.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

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.

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 (Estimated)

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.
154

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.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Rothman Orthopaedic Institute

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Paticipants with ACL rupture amenable to reconstruction with BTB autograft identified in clinic by one of 4 different surgeons
  • Primary ACL Reconstruction with Autograft +/- Partial meniscectomy +/- Lateral extra-articular tenodesis
  • Age 18 and older
  • English speaking
  • Ability to complete surveys by phone or in person
  • Ability to provide informed consent

Exclusion Criteria:

  • Revision cases
  • Multi-ligamentous knee injuries
  • Cartilage or meniscal procedures that prevent adherence to immediate weight bearing and range of motion rehab protocol
  • ACL reconstruction utilizing non-bone-patellar tendon-bone autografts
  • Allergies to study medications
  • Non-English speakers
  • Known alcohol or narcotic abuse history
  • Existing contract with a pain specialist due to underlying preoperative pain syndrome
  • Preoperative opioid use within the 3 months prior to 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: Double

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.
Active Comparator: Group 1: ACL repair + Exparel + nerve block
30 mL Liposomal bupivacaine (Exparel) + 5 cc's of 0.5% bupivacaine evenly distributed and administered in adductor canal and iPACK block (35 mL total)
Drug: Exparel 30 mL
30 mL Liposomal bupivacaine (Exparel) evenly distributed and administered in adductor canal block
Drug: 0.5% bupivacaine
5 cc's of 0.5% bupivacaine evenly distributed and administered in adductor canal
Drug: iPACK block
iPACK (Infiltration between the Popliteal artery and Capsule of the Knee) block
Active Comparator: Group 2: ACL repair + Exparel + Dexamethasone + nerve block
30 mL Liposomal bupivacaine (Exparel) + 10 mg preservative free Dexamethasone + 5 cc's of 0.5% bupivacaine evenly distributed for both adductor canal and iPACK block (35 mL total)
Drug: Exparel 30 mL
30 mL Liposomal bupivacaine (Exparel) evenly distributed and administered in adductor canal block
Drug: 0.5% bupivacaine
5 cc's of 0.5% bupivacaine evenly distributed and administered in adductor canal
Drug: iPACK block
iPACK (Infiltration between the Popliteal artery and Capsule of the Knee) block
Drug: Dexamethasone
10 mg preservative free Dexamethasone evenly distributed and administered in adductor canal

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
Postoperative Pain
Time Frame: 14 days
Daily postoperative VAS (visual analog scale for pain) scale will be collected from participants to assess pain
14 days
Postoperative opioid use
Time Frame: 14 days
assessed using a participant daily diary of how much medication was taken daily for pain
14 days
Postoperative Pain #2
Time Frame: 14 days
Daily postoperative NRS (numerical rating scale for pain) scale will be collected from participants to assess pain
14 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.
Rothman Institute Orthopaedics

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.
August 21, 2023

Primary Completion (Estimated)

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.
October 30, 2024

Study Completion (Estimated)

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.
October 30, 2024

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).
August 17, 2023

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.
August 22, 2023

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.
August 23, 2023

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.
June 21, 2024

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.
June 19, 2024

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.
June 1, 2024

More Information

Terms related to this study

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.
  • SHAM2023-2163

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

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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