Local Infiltration Analgesia With and Without EXPAREL Following Total Knee Arthroplasty
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator
Primary Purpose: Treatment
|Official Title:||A Multicenter, Randomized, Double-Blind, Controlled Trial Comparing Local Infiltration Analgesia With EXPAREL to Local Infiltration Analgesia Without EXPAREL to Manage Postsurgical Pain Following Total Knee Arthroplasty|
- Area under the curve (AUC) of the VAS pain intensity scores [ Time Frame: From 12-48 hours ]
- Total opioid consumption (in IV morphine equivalents) [ Time Frame: From 0-48 hours ]
- The AUC of the VAS pain intensity score through 24 hours [ Time Frame: Through 24 hours ]
- The AUC of the VAS pain intensity score through 36 hours [ Time Frame: Through 36 hours ]
- The AUC of the VAS pain intensity score through 48 hours [ Time Frame: Through 48 hours ]
- The AUC of the VAS pain intensity score through 60 hours [ Time Frame: Through 60 hours ]
- The AUC of the VAS pain intensity score through 72 hours [ Time Frame: Through 72 hours ]
- Incidence of treatment-emergent adverse events or serious adverse events [ Time Frame: Through postsurgical Day 29 ]
|Study Start Date:||March 2016|
|Estimated Study Completion Date:||March 2017|
|Estimated Primary Completion Date:||March 2017 (Final data collection date for primary outcome measure)|
Active Comparator: EXPAREL
Single dose of EXPAREL 266 mg in 20 mL admixed with bupivacaine HCl 0.5% in 20 mL and expanded in volume with 80 mL normal saline (total volume of 120 mL).
EXPAREL and bupivacaine HCl
Other Name: bupivacaine liposome injectable suspensionDrug: Bupivacaine
Single dose of bupivacaine HCl 0.5%
Other Name: bupivacaine HCl
Active Comparator: Bupivacaine
Bupivacaine HCl 0.5% in 20 mL expanded in volume with 100 mL normal saline (total volume of 120 mL).
Single dose of bupivacaine HCl 0.5%
Other Name: bupivacaine HCl
On Day 0, eligible subjects will be randomized 1:1 to two treatment groups. Subjects in Group 1 will receive local infiltration analgesia (LIA) with EXPAREL 266 mg in 20 mL admixed with bupivacaine hydrochloride (HCl) 0.5% in 20 mL and expanded in volume with 80 mL normal saline (total volume of 120 mL). Subjects in Group 2 will receive LIA with bupivacaine HCl 0.5% in 20 mL expanded in volume with 100 mL normal saline (total volume of 120 mL). Investigators will use their usual surgical technique to perform the TKA.
Study drug will be administered using six 20 cc syringes with 22-gauge needles prior to wound closure. Each stick should deliver approximately 1-1.5 cc to the intended area. The tissue should visibly expand with minimal leakage. Study drug should be injected in the prescribed locations based on the areas of highest nerve density.
Prior to cementation
Syringe #1: Posterior capsule (8-10 sticks medial and 8-10 sticks lateral).
Syringe #2: Femur medial and lateral periosteum, posterior periosteum, suprapatellar/quadriceps tendon (20 sticks).
Syringe #3: Tibia fat pad (5 sticks); pes anserinus, medial collateral ligament, and gutter (15 sticks).
Syringe #4: Circumferential periosteum (15-20 sticks).
Syringe #5: Midline quadriceps tendon (10 sticks); retinaculum, medial gutter, femoral to tibia (10 sticks).
Syringe #6: Lateral gutter, femoral to tibial (10 sticks); subcutaneous/closure (10 sticks).
In addition to LIA, all study participants will receive a standardized approach for managing postsurgical pain that includes a scheduled multimodal pain regimen including adjunctive analgesics, non-steroidal anti-inflammatory drugs (NSAIDs), and rescue analgesics as needed.
Postsurgical clinical assessments will include pain intensity scores using a 10-cm visual analog scale (VAS); overall benefit of analgesia score (OBAS) questionnaire; total postsurgical opioid consumption; physical therapy assessment; nurse's satisfaction with overall analgesia; and discharge readiness. Adverse events (AEs) will be recorded from the time the informed consent form is signed through postsurgical Day 29.
Postsurgical health economic outcome assessments will include hospital length of stay (LOS), use of skilled nursing facility, outpatient physical therapy use, hospital readmissions, and use of other health services following discharge (phone calls related to postsurgical pain, unscheduled visits related to postsurgical pain, and visits to emergency department) through postsurgical Day 29.
A follow-up visit will be scheduled for all subjects on postsurgical Day 14. A follow-up phone call will be made on postsurgical Day 29 to all subjects who received study drug to assess for AEs.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02713490
|United States, California|
|Institute for Joint Restoration|
|Fremont, California, United States, 94538|
|Loma Linda University|
|Loma Linda, California, United States, 92354|
|United States, Florida|
|Holy Cross Hospital|
|Fort Lauderdale, Florida, United States, 33334|
|Cleveland Clinic Florida|
|Weston, Florida, United States, 33331|
|United States, Georgia|
|Pinnacle Orthopaedics & Sports|
|Marietta, Georgia, United States, 30060|
|United States, Illinois|
|Central DuPage Hospital, Northwestern Medicine|
|Winfield, Illinois, United States, 60190|
|United States, Maryland|
|Sinai Hospital of Baltimore|
|Baltimore, Maryland, United States, 21215|
|Towson, Maryland, United States, 21204|
|United States, New York|
|NYU Hospital for Joint Disease|
|New York, New York, United States, 10003|
|Lenox Hill Hospital/Northwell Health Orthopaedic Institute|
|New York, New York, United States, 10075|
|United States, North Carolina|
|UNC Orthopaedics Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599|
|Charlotte, North Carolina, United States, 28207|
|United States, Ohio|
|Wellington Orthopaedics and Sports Medicine|
|Cincinnati, Ohio, United States, 45209|
|Cleveland, Ohio, United States, 44195|
|United States, Texas|
|San Antonio Military Medical Center|
|Fort Sam Houston, Texas, United States, 78234|
|Baylor Medical Center, Plano Orthopedics Sports Medical & Spine Center|
|Frisco, Texas, United States, 75034|
|United States, Utah|
|Utah University Orthopedic Center|
|Salt Lake City, Utah, United States, 84108|
|Study Director:||James B Jones, MD, PharmD||Pacira Pharmaceuticals, Inc|