Exparel vs Block for ACL Reconstruction

NCT06006624 | Enrolling By Invitation Phase 4 FDA Drug

• 1 other identifier: SHAM2023-2163
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

ACL; Postoperative Pain

Outcome Measures

Primary Outcomes (3)

• Postoperative Pain

  Daily postoperative VAS (visual analog scale for pain) scale will be collected from participants to assess pain

  14 days

• Postoperative opioid use

  assessed using a participant daily diary of how much medication was taken daily for pain

  14 days

• Postoperative Pain #2

  Daily postoperative NRS (numerical rating scale for pain) scale will be collected from participants to assess pain

  14 days

Study Arms (2)

Group 1: ACL repair + Exparel + nerve block

ACTIVE COMPARATOR

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; Drug: 0.5% bupivacaine; Drug: iPACK block

Group 2: ACL repair + Exparel + Dexamethasone + nerve block

ACTIVE COMPARATOR

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; Drug: 0.5% bupivacaine; Drug: Dexamethasone; Drug: iPACK block

Interventions

Exparel 30 mL DRUG

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

Group 1: ACL repair + Exparel + nerve block; Group 2: ACL repair + Exparel + Dexamethasone + nerve block

0.5% bupivacaine DRUG

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

Group 1: ACL repair + Exparel + nerve block; Group 2: ACL repair + Exparel + Dexamethasone + nerve block

Dexamethasone DRUG

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

Group 2: ACL repair + Exparel + Dexamethasone + nerve block

iPACK block DRUG

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

Group 1: ACL repair + Exparel + nerve block; Group 2: ACL repair + Exparel + Dexamethasone + nerve block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rothman Institute Orthopaedics: lead

Study Sites (1)

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

• Johns WL, Voskeridjian A, Miltenberg B, Muchintala R, Dodson CC, Cohen SB, Salvo J, Sherman M, Ciccotti MG, Hammoud S. Regional Anesthesia Utilizing Liposomal Bupivacaine, With or Without Dexamethasone, Provides Excellent Pain Control and Minimizes Opioid Consumption Following Anterior Cruciate Ligament Reconstruction. Orthop J Sports Med. 2026 Jan 8;14(1):23259671251401596. doi: 10.1177/23259671251401596. eCollection 2026 Jan.

  PMID: 41522461 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Dexamethasone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: August 23, 2023
• Study Start: August 21, 2023
• Primary Completion: October 30, 2024
• Study Completion: October 30, 2024
• Last Updated: June 21, 2024

Record last verified: 2024-06

Locations

US (1)