Exparel vs Block for ACL Reconstruction

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06006624
• Other study ID #: SHAM2023-2163
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: August 21, 2023
• Est. completion date: October 30, 2024

Study information

• Verified date: August 2023
• Source: Rothman Institute Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 154
• Est. completion date: October 30, 2024
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ACL
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Exparel 30 mL
30 mL Liposomal bupivacaine (Exparel) evenly distributed and administered in adductor canal block
• 0.5% bupivacaine
5 cc's of 0.5% bupivacaine evenly distributed and administered in adductor canal
• Dexamethasone
10 mg preservative free Dexamethasone evenly distributed and administered in adductor canal
• iPACK block
iPACK (Infiltration between the Popliteal artery and Capsule of the Knee) block

Locations

Country	Name	City	State
United States	Rothman Orthopaedic Institute	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Pain	Daily postoperative VAS (visual analog scale for pain) scale will be collected from participants to assess pain	14 days
Primary	Postoperative opioid use	assessed using a participant daily diary of how much medication was taken daily for pain	14 days
Primary	Postoperative Pain #2	Daily postoperative NRS (numerical rating scale for pain) scale will be collected from participants to assess pain	14 days