Exparel vs Block for ACL Reconstruction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE4

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-21

Study Completion Date

2024-10-30

Brief Summary

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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.

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Detailed Description

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Conditions

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ACL Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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)

Group Type ACTIVE_COMPARATOR

Exparel 30 mL

Intervention Type DRUG

30 mL Liposomal bupivacaine (Exparel) evenly distributed and administered in adductor canal block

0.5% bupivacaine

Intervention Type DRUG

5 cc's of 0.5% bupivacaine evenly distributed and administered in adductor canal

iPACK block

Intervention Type DRUG

iPACK (Infiltration between the Popliteal artery and Capsule of the Knee) block

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)

Group Type ACTIVE_COMPARATOR

Exparel 30 mL

Intervention Type DRUG

30 mL Liposomal bupivacaine (Exparel) evenly distributed and administered in adductor canal block

0.5% bupivacaine

Intervention Type DRUG

5 cc's of 0.5% bupivacaine evenly distributed and administered in adductor canal

Dexamethasone

Intervention Type DRUG

10 mg preservative free Dexamethasone evenly distributed and administered in adductor canal

iPACK block

Intervention Type DRUG

iPACK (Infiltration between the Popliteal artery and Capsule of the Knee) block

Interventions

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Exparel 30 mL

30 mL Liposomal bupivacaine (Exparel) evenly distributed and administered in adductor canal block

Intervention Type DRUG

0.5% bupivacaine

5 cc's of 0.5% bupivacaine evenly distributed and administered in adductor canal

Intervention Type DRUG

Dexamethasone

10 mg preservative free Dexamethasone evenly distributed and administered in adductor canal

Intervention Type DRUG

iPACK block

iPACK (Infiltration between the Popliteal artery and Capsule of the Knee) block

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes