Efficacy, Safety, and Pharmacokinetics of Femoral Nerve Block With EXPAREL in Total Knee Arthroplasty
NCT ID: NCT02713178
Last Updated: 2020-12-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
232 participants
INTERVENTIONAL
2016-06-03
2017-06-30
Brief Summary
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Detailed Description
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Postsurgical assessments will include pain intensity scores using a 10-cm visual analog scale (VAS); total postsurgical opioid consumption; overall benefit of analgesia score (OBAS) questionnaire; subject satisfaction with overall analgesia using a 5-point Likert scale; neurological assessment; sensory function assessment; motor function assessment; the study physical therapy assessments (ie, timed walk, timed up and go, and stair climbing tests); discharge readiness; unscheduled phone calls or office visits related to pain; 12-lead ECGs; vital sign measurements; and clinical laboratory tests. Adverse events will be recorded from the time the informed consent form (ICF) is signed through postsurgical Day 29.
Follow-up visits will be scheduled for all subjects on postsurgical Days 6 and 10. A follow-up phone call will be made on postsurgical Day 29.
Pharmacokinetic (PK) parameters will be estimated from plasma bupivacaine measurements using non-compartmental analysis based on the sampling schedule of baseline (prior to the nerve block) through postsurgical Day 10.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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EXPAREL 133 mg
Single dose of 133 mg (10 mL) EXPAREL (bupivacaine liposome injectable suspension) expanded in volume with 10 mL of normal saline for a total volume of 20 mL.
bupivacaine liposome injectable suspension
bupivacaine liposome injectable suspension 133 mg expanded with normal saline to 20 mL or 266 mg in 20 mL
EXPAREL 266 mg
Single dose of 266 mg (20 mL) EXPAREL (bupivacaine liposome injectable suspension).
bupivacaine liposome injectable suspension
bupivacaine liposome injectable suspension 133 mg expanded with normal saline to 20 mL or 266 mg in 20 mL
Placebo
Normal saline (20 mL).
Placebo
Normal saline.
Interventions
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bupivacaine liposome injectable suspension
bupivacaine liposome injectable suspension 133 mg expanded with normal saline to 20 mL or 266 mg in 20 mL
Placebo
Normal saline.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Scheduled to undergo primary unilateral TKA under general or spinal anesthesia.
3. American Society of Anesthesiologists (ASA) physical status 1, 2, or 3.
4. Female subject 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.
5. Able to demonstrate sensory function by exhibiting sensitivity to cold, pinprick, and light touch.
6. Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments.
Exclusion Criteria
2. Planned concurrent surgical procedure (e.g., bilateral TKA).
3. 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).
4. Previous open knee surgery on the knee being considered for TKA. Prior arthroscopy is permitted.
5. History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics.
6. Contraindication to any one of the following: bupivacaine, oxycodone, morphine, or hydromorphone.
7. 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.
8. 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.
9. Current use of systemic glucocorticosteroids within 1 month of enrollment in this study.
10. Use of dexmedetomidine HCl (Precedex®) within 3 days of study drug administration.
11. History of impaired kidney function, poorly controlled chronic respiratory disease, rheumatoid arthritis, coagulopathy, or loss of sensation in extremities.
12. Impaired kidney function (e.g., serum creatinine level \>2 mg/dL \[176.8 µmol/L\] or blood urea nitrogen level \>50 mg/dL \[17.9 mmol/L\]) or impaired liver function (e.g., serum aspartate aminotransferase \[AST\] level \>3 times the upper limit of normal \[ULN\] or serum alanine aminotransferase \[ALT\] level \>3 times the ULN.)
13. Uncontrolled anxiety, psychiatric, or neurological disorder that might interfere with study assessments.
14. Any chronic neuromuscular deficit effecting the peripheral nerves or muscles of the surgical extremity.
15. Any chronic condition or disease that would compromise neurological or vascular assessments.
16. Malignancy in the last 2 years, with the exception of non-metastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.
17. Suspected or known history of drug or alcohol abuse within the previous year.
18. Body weight \<50 kg (110 pounds) or a body mass index \>44 kg/m2.
19. Previous participation in an EXPAREL study.
20. 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.
18 Years
ALL
No
Sponsors
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Pacira Pharmaceuticals, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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James B Jones, MD, PharmD
Role: STUDY_DIRECTOR
Pacira Pharmaceuticals, Inc
Locations
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Horizon Research Group, Inc
Mobile, Alabama, United States
Denver Metro Orthopedics
Englewood, Colorado, United States
Jackson Memorial Hospital/University of Miami
Miami, Florida, United States
Pensacola Research Associates
Pensacola, Florida, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Montefiore Medical Center
The Bronx, New York, United States
Fairview Hospital
Cleveland, Ohio, United States
Indiana Regional Medical Center
Indiana, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Chan Soon-Shiong Medical Center
Windber, Pennsylvania, United States
Hermann Drive Surgical Hospital
Houston, Texas, United States
Westside Surgical Hospital
Houston, Texas, United States
Southampton Orthopaedics Sports Medicine
Franklin, Virginia, United States
Ziekenhuis Oost-Limburg
Genk, , Belgium
Aarhus University Hospital
Aarhus C, , Denmark
Regionshospital Silkeborg
Silkeborg, , Denmark
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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402-C-326
Identifier Type: -
Identifier Source: org_study_id