Total Shoulder Arthroplasty or Rotator Cuff Repair MedDRA version: 18.1 Level: LLT Classification code 10038286 Term: Regional nerve block System Organ Class: 100000004865
Conditions
Interventions
Product Name: EXPAREL
Product Code: SKY0402
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: BUPIVACAINE
CAS Number: 2180-92-9
Current Sponsor code: N/A (Pacira part numbers: 10004)
Sponsors
Pacira Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female, at least 18 years of age at screening. 2. Scheduled to undergo primary unilateral total shoulder arthroplasty or rotator cuff repair. 3. Subjects scheduled for rotator cuff repair must have a magnetic resonance imaging (MRI) with a reading confirming a tear of at least 1 cm. 4. American Society of Anesthesiologists (ASA) physical status 1, 2, or 3. 5. 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. 6. Able to demonstrate normal motor function (by obtaining a 5 on the Lovett Scale when exhibiting biceps, wrist, and thumb movement) and sensory function (by exhibiting sensitivity to cold, pinprick, and light touch) in the location where sensory function will be measured throughout the study: 2 cm superior to the coracoid process on the skin overlying the acromioclavicular joint. 7. Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: 1. Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after study drug administration. 2. Planned concurrent surgical procedure. 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 shoulder surgery and which may confound the postsurgical assessments (e.g., significant pain from other joints, chronic neuropathic pain). 4. History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics. 5. Smoking history of greater than 25 pack-years. 6. Contraindication to bupivacaine or oxycodone. Use of any of the following medications within the times specified before surgery: long-acting opioid medications or NSAIDs (except for low-dose aspirin used for cardioprotection) within 3 days, or any opioid medication within 24 hours. 7. Use of any of the following medications within the times specified before surgery: long-acting opioid medications 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, emphysema or other 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the magnitude and duration of the analgesic effect achieved following single-dose injection brachial plexus block with EXPAREL in subjects undergoing primary unilateral total shoulder arthroplasty or rotator cuff repair.;Secondary Objective: The secondary objectives of this study are to assess the efficacy, safety, and PK profiles of EXPAREL, as well as the onset and duration of sensory and motor function blockade, following administration for analgesia in subjects undergoing primary unilateral total shoulder arthroplasty or rotator cuff repair.;Primary end point(s): The primary endpoint is the AUC of the VAS pain intensity scores through 48 hours.;Timepoint(s) of evaluation of this end point: through 48 hours after surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The following secondary endpoints will be analyzed in the following order using a hierarchical fixed-sequence stepwise testing procedure: 1. Total postsurgical opioid consumption (in IV morphine equivalents) through 48 hours. 2. Percentage of opioid-free subjects through 48 hours. 3. Time to first opioid rescue through 48 hours.;Timepoint(s) of evaluation of this end point: through 48 hours after surgery. | — |
Countries
Belgium, Denmark
Contacts
Public ContactClinical Research Director
Pacira Pharmaceuticals, Inc.
Outcome results
None listed