ACL, Postoperative Pain
Conditions
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.
Interventions
DRUGExparel 30 mL
30 mL Liposomal bupivacaine (Exparel) evenly distributed and administered in adductor canal block
DRUG0.5% bupivacaine
5 cc's of 0.5% bupivacaine evenly distributed and administered in adductor canal
DRUGDexamethasone
10 mg preservative free Dexamethasone evenly distributed and administered in adductor canal
DRUGiPACK block
iPACK (Infiltration between the Popliteal artery and Capsule of the Knee) block
Sponsors
Rothman Institute Orthopaedics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain | 14 days | Daily postoperative VAS (visual analog scale for pain) scale will be collected from participants to assess pain |
| Postoperative opioid use | 14 days | assessed using a participant daily diary of how much medication was taken daily for pain |
| Postoperative Pain #2 | 14 days | Daily postoperative NRS (numerical rating scale for pain) scale will be collected from participants to assess pain |
Countries
United States
Outcome results
None listed