Exparel vs Block for ACL Reconstruction

• Sponsor: Rothman Institute Orthopaedics (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT06006624
• Collaborator: (none)
• Enrollment: 154
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 14.3
• Patients Per Site Per Month: 10.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
ACL; Postoperative Pain	Drug: Exparel 30 mL; Drug: 0.5% bupivacaine; Drug: Dexamethasone; Drug: iPACK block	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 154 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• Official Title: Single-Shot Liposomal Bupivacaine vs. Liposomal Bupivacaine Combined With Dexamethasone Following Anterior Cruciate Ligament Reconstruction: A Prospective Randomized Controlled Trial
• Anticipated Study Start Date: Aug 21, 2023
• Anticipated Primary Completion Date: Oct 30, 2024
• Anticipated Study Completion Date: Oct 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
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: Dexamethasone; 10 mg preservative free Dexamethasone evenly distributed and administered in adductor canal; Drug: iPACK block; iPACK (Infiltration between the Popliteal artery and Capsule of the Knee) block

Outcome Measures

Primary Outcome Measures

1. Postoperative Pain [14 days]

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

2. Postoperative opioid use [14 days]

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

3. Postoperative Pain #2 [14 days]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rothman Orthopaedic Institute	Philadelphia	Pennsylvania	United States	19107

Sponsors and Collaborators

• Rothman Institute Orthopaedics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rothman Institute Orthopaedics
• ClinicalTrials.gov Identifier: NCT06006624
• Other Study ID Numbers: SHAM2023-2163
• First Posted: Aug 23, 2023
• Last Update Posted: Aug 23, 2023
• Last Verified: Aug 1, 2023

• 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
• Additional relevant MeSH terms: Pain, Postoperative; Dexamethasone; Bupivacaine

Study Results

No Results Posted as of Aug 23, 2023