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Exparel vs Block for ACL Reconstruction

Primary Purpose

ACL, Postoperative Pain

Status
Enrolling by invitation
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Exparel 30 mL
0.5% bupivacaine
Dexamethasone
iPACK block
Sponsored by
Rothman Institute Orthopaedics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ACL

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Rothman Orthopaedic Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group 1: ACL repair + Exparel + nerve block

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

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 17, 2023
Last Updated
August 22, 2023
Sponsor
Rothman Institute Orthopaedics
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1. Study Identification

Unique Protocol Identification Number
NCT06006624
Brief Title
Exparel vs Block for ACL Reconstruction
Official Title
Single-Shot Liposomal Bupivacaine vs. Liposomal Bupivacaine Combined With Dexamethasone Following Anterior Cruciate Ligament Reconstruction: A Prospective Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 21, 2023 (Anticipated)
Primary Completion Date
October 30, 2024 (Anticipated)
Study Completion Date
October 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rothman Institute Orthopaedics

4. Oversight

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

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ACL, Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
154 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1: ACL repair + Exparel + nerve block
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Group 2: ACL repair + Exparel + Dexamethasone + nerve block
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Exparel 30 mL
Intervention Description
30 mL Liposomal bupivacaine (Exparel) evenly distributed and administered in adductor canal block
Intervention Type
Drug
Intervention Name(s)
0.5% bupivacaine
Intervention Description
5 cc's of 0.5% bupivacaine evenly distributed and administered in adductor canal
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
10 mg preservative free Dexamethasone evenly distributed and administered in adductor canal
Intervention Type
Drug
Intervention Name(s)
iPACK block
Intervention Description
iPACK (Infiltration between the Popliteal artery and Capsule of the Knee) block
Primary Outcome Measure Information:
Title
Postoperative Pain
Description
Daily postoperative VAS (visual analog scale for pain) scale will be collected from participants to assess pain
Time Frame
14 days
Title
Postoperative opioid use
Description
assessed using a participant daily diary of how much medication was taken daily for pain
Time Frame
14 days
Title
Postoperative Pain #2
Description
Daily postoperative NRS (numerical rating scale for pain) scale will be collected from participants to assess pain
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Rothman Orthopaedic Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

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Exparel vs Block for ACL Reconstruction

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