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Trial record 1 of 1 for:    402-c-331
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Local Infiltration Analgesia With and Without EXPAREL Following Total Knee Arthroplasty

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT02713490
First received: March 15, 2016
Last updated: January 24, 2017
Last verified: January 2017
  Purpose
This is a Phase 4, multicenter, randomized, double-blind, controlled trial in approximately 300 adult subjects undergoing primary unilateral TKA under spinal anesthesia with bupivacaine HCl (10-15 mg).

Condition Intervention Phase
Pain
Drug: EXPAREL
Drug: Bupivacaine
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Pacira Pharmaceuticals, Inc:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • Incidence of treatment-emergent adverse events or serious adverse events [ Time Frame: Through postsurgical Day 29 ]

Estimated Enrollment: 300
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)
Arms Assigned Interventions
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).
Drug: EXPAREL
EXPAREL and bupivacaine HCl
Other Name: bupivacaine liposome injectable suspension
Drug: 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).
Drug: Bupivacaine
Single dose of bupivacaine HCl 0.5%
Other Name: bupivacaine HCl

Detailed Description:

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.

Infiltration Technique

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).

After cementation

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female, at least 18 years of age at screening.
  2. Scheduled to undergo primary, unilateral, tricompartmental TKA under spinal anesthesia.
  3. Primary indication for TKA is degenerative osteoarthritis of the knee.
  4. American Society of Anesthesiologists (ASA) physical status 1, 2, or 3.
  5. Female subjects must be surgically sterile; or at least 2 years postmenopausal; or have a monogamous partner who is surgically sterile; or practicing double-barrier contraception; or practicing abstinence (must agree to use double-barrier contraception in the event of sexual activity); or using an insertable, injectable, transdermal, or combination oral contraceptive approved by the FDA for greater than 2 months prior to screening and commit to the use of an acceptable form of birth control for the duration of the study and for 30 days after completion of the study.
  6. Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments.

Exclusion Criteria:

  1. Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after study drug administration.
  2. History of previous prior contralateral TKA or open knee surgery on the knee being considered for TKA. Prior arthroscopy is permitted.
  3. Planned concurrent surgical procedure (e.g., bilateral TKA).
  4. Undergoing unicompartmental TKA or revision TKA.
  5. Concurrent painful physical condition that may require analgesic treatment (such as an NSAID or opioid) in the postsurgical period for pain that is not strictly related to the knee surgery and which may confound the postsurgical assessments (e.g., significant pain from other joints including the non-index knee joint, chronic neuropathic pain, concurrent or prior contralateral TKA, concurrent foot surgery).
  6. Comorbidity impacting current physical function of Investigator opinion that it may impact postsurgical rehabilitation.
  7. Allergy, hypersensitivity, or contraindication to any of the study medications (i.e., bupivacaine, pregabalin, acetaminophen/paracetamol, celecoxib, oxycodone, morphine, hydromorphone, or tranexamic acid).
  8. Use of any of the following medications within the times specified before surgery: long-acting opioid medication or NSAIDs (except for low-dose aspirin used for cardioprotection) within 3 days, or any opioid medication within 24 hours.
  9. Initiation of treatment with any of the following medications within 1 month of study drug administration or if the medication(s) are being given to control pain: selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin, pregabalin (Lyrica®), or duloxetine (Cymbalta®). If a subject is taking one of these medications for a reason other than pain control, he or she must be on a stable dose for at least 1 month prior to study drug administration.
  10. Current use of systemic glucocorticosteroids within 1 month of enrollment in this study.
  11. Use of dexmedetomidine HCl (Precedex®) within 3 days of study drug administration.
  12. History of coronary or vascular stent placed within the past 3 months (may be extended to 1 year if medically indicated per physician discretion).
  13. Have been treated for a deep vein thrombosis, pulmonary embolism, myocardial infarction, or ischemic stroke within the past 6 months (may be extended to 1 year if medically indicated per physician discretion).
  14. Rheumatoid or inflammatory arthritis or disease.
  15. Severely impaired renal or hepatic function (e.g., serum creatinine level >2 mg/dL [176.8 µmol/L], blood urea nitrogen level >50 mg/dL [17.9 mmol/L], serum aspartate aminotransferase [AST] level >3 times the upper limit of normal [ULN], or serum alanine aminotransferase [ALT] level >3 times the ULN.)
  16. Any neurologic or psychiatric disorder that might impact postsurgical pain or interfere with study assessments.
  17. Malignancy in the last 2 years, per physician discretion.
  18. History of misuse, abuse, or dependence on opioid analgesics, other prescription drugs, illicit drugs, or alcohol.
  19. Failure to pass the alcohol breath test or urine drug screen.
  20. Body weight <50 kg (110 pounds) or a body mass index >40 kg/m2.
  21. Previous participation in an EXPAREL study.
  22. Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02713490

Locations
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
Orthopaedic Associates
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
OrthoCarolina, PA
Charlotte, North Carolina, United States, 28207
United States, Ohio
Wellington Orthopaedics and Sports Medicine
Cincinnati, Ohio, United States, 45209
Cleveland Clinic
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
Sponsors and Collaborators
Pacira Pharmaceuticals, Inc
Investigators
Study Director: James B Jones, MD, PharmD Pacira Pharmaceuticals, Inc
  More Information

Responsible Party: Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT02713490     History of Changes
Other Study ID Numbers: 402-C-331
Study First Received: March 15, 2016
Last Updated: January 24, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 24, 2017