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Trial record 1 of 1 for:    402-C-327
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Efficacy, Safety, and Pharmacokinetics of Brachial Plexus Block With EXPAREL in Shoulder Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2017 by Pacira Pharmaceuticals, Inc
Sponsor:
Information provided by (Responsible Party):
Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT02713230
First received: March 15, 2016
Last updated: April 28, 2017
Last verified: January 2017
  Purpose
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study in approximately 120 adult subjects undergoing primary unilateral total shoulder arthroplasty or rotator cuff repair with general anesthesia

Condition Intervention Phase
Pain
Drug: bupivacaine liposome injectable suspension
Drug: Placebo
Phase 3

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, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Pharmacokinetics of Brachial Plexus Block With EXPAREL for Postsurgical Analgesia in Subjects Undergoing Total Shoulder Arthroplasty or Rotator Cuff Repair

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: Through 48 hours ]

Secondary Outcome Measures:
  • Total postsurgical opioid consumption (in IV morphine equivalents) [ Time Frame: Through 48 hours ]
  • Percentage of opioid-free subjects [ Time Frame: Through 48 hours ]
  • Time to first opioid rescue [ Time Frame: Through 48 hours ]

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

Estimated Enrollment: 120
Study Start Date: March 2016
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: EXPAREL 133 mg
EXPAREL (bupivacaine liposome injectable suspension) 133 mg in 10 mL expanded with 10 mL of normal saline for a total volume of 20 mL.
Drug: bupivacaine liposome injectable suspension
bupivacaine liposome injectable suspension,133 mg in 10 mL expanded with normal saline to 20 mL
Other Name: EXPAREL
Placebo Comparator: Placebo
Normal saline in 20 mL.
Drug: Placebo
Normal saline in 20 mL.
Other Name: Normal saline

Detailed Description:

On Day 0, eligible subjects will be randomized in a 1:1 ratio to receive a single dose of EXPAREL 133 mg in 10 mL expanded in volume with 10 mL of normal saline for a total volume of 20 mL or placebo 20 mL. Study drug (EXPAREL or placebo) will be administered in a blinded manner via an ultrasound guided single-dose brachial plexus block at least 1 hour prior to surgery.

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; 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 is signed through postsurgical Day 29.

Follow-up visits will be scheduled for all subjects on postsurgical Days 5 and 10. A follow-up phone call will be made on postsurgical Day 29.

A population Pharmacokinetic (PK) analysis will be utilized to limit the number of blood draws with a sampling schedule of baseline (prior to the nerve block) through hospital discharge. There will be two collection sequences for this study and a subject can only be randomized to one sequence.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 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.

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 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 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 hydrochloride (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 <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.
  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: NCT02713230

Contacts
Contact: Hassan Danesi 973-451-4047 hassan.danesi@pacira.com

Locations
United States, Alabama
Brookwood Medical Center Withdrawn
Birmingham, Alabama, United States, 35209
Horizon Research Group, Inc Recruiting
Mobile, Alabama, United States, 36608
Contact: Elizabeth Hess    251-410-3705    lhess@horizonresearch.us   
Principal Investigator: Robert Calin, MD         
United States, Colorado
Denver Metro Orthopedics Not yet recruiting
Englewood, Colorado, United States, 80113
Contact: Hannah Olds    303-789-3000    hannah.olds@colorado.edu   
Principal Investigator: John Schwappach, MD         
United States, Florida
Shrock Orthopedic Research Not yet recruiting
Fort Lauderdale, Florida, United States, 33316
Contact: Natalie Shrock    954-626-3743    natalie@shrockresearch.com   
Principal Investigator: Kevin Shrock, MD         
Jackson Memorial Hospital/University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Margarita Nieto Moreno       m.nieto@med.miami.edu   
Contact: Alessandro Colantuono    305-585-7677      
Principal Investigator: Keith Candiotti, MD         
Pensacola Research Associates Recruiting
Pensacola, Florida, United States, 32504
Contact: Amanda Satterwhite    850-477-7900 ext 2003    a.satterwhite@pensacolaresearch.com   
Contact: Donna Lawson    850-477-7900 ext 2105    d.lawson@pensacolaresearch.com   
Principal Investigator: E J Dabezies, Jr., MD         
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Ashish Bhandari    617-732-9816    abhandari1@partners.org   
Principal Investigator: Srdjan Nedeljkovic, MD         
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02215
Contact: Ashish Bhandari    617-732-9816    abhandari1@partners.org   
Principal Investigator: Srdjan Nedeljkovic, MD         
United States, New York
Stony Brook Medicine Recruiting
Stony Brook, New York, United States, 11794
Contact: Sabeen Rizwan    631-638-1214    sabeen.rizwan@stonybrookmedicine.edu   
Principal Investigator: Syed Azim, MD         
Montefiore Medical Center Recruiting
The Bronx, New York, United States, 10467
Contact: Singh Nair    718-920-5932    sinair@montefiore.edu   
Principal Investigator: Boleslav Kosharskyy, MD         
United States, North Carolina
Duke University Medical Center Recruiting
Raleigh-Durham, North Carolina, United States, 27710
Contact: Alicia Pucci    919-684-8111    alicia.pucci@duke.edu   
Principal Investigator: Jeffrey Gadsden, MD         
United States, Ohio
Fairview Hospital Not yet recruiting
Cleveland, Ohio, United States, 44111
Principal Investigator: Sabry Ayad, MD         
United States, Pennsylvania
Indiana Regional Medical Center Recruiting
Indiana, Pennsylvania, United States, 15701
Contact: David Bizousky    724-349-0520    dbizousky@pacosm.com   
Principal Investigator: David Bizousky, MD         
Thomas Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Robert Machnicki    610-348-3537    robert.machnicki@jefferson.edu   
Contact: Jennifer Lessin    215-955-6161    jennifer.lessin@jefferson.edu   
Principal Investigator: Eugene Viscusi, MD         
United States, Texas
Hermann Drive Surgical Hospital Recruiting
Houston, Texas, United States, 77004
Contact: Lauren Howard    281-770-5752    lauren@minkowitzmd.com   
Principal Investigator: David Leiman, MD         
Westside Surgical Hospital Recruiting
Houston, Texas, United States, 77027
Contact: Sandra Bailon    713-480-3028    sandra@minkowitzmd.com   
Contact: Pam Lindley    832-567-2273    pam@minkowitzmd.com   
Principal Investigator: Harold Minkowitz, MD         
Plano Surgical Hospital Not yet recruiting
Plano, Texas, United States, 75093
Principal Investigator: Julie Greene, MD         
Houston Physician's Hospital Not yet recruiting
Webster, Texas, United States, 77598
Principal Investigator: Harold Adams         
United States, Virginia
Southampton Orthopedics Sports Medicine Recruiting
Franklin, Virginia, United States, 23851
Contact: Vaishali Patel    267-968-5239    research@summitcr.com   
Principal Investigator: Manish Patel, MD         
Belgium
Ziekenhuis Oost-Limburg Recruiting
Genk, Belgium, 3600
Contact: Marijke Cipers       marijke.cipers@zol.be   
Principal Investigator: Sam Van Boxstael, MD         
Denmark
Aarhus University Hospital Recruiting
Aarhus, Denmark, 8000
Contact: Siska Bjørn    +45 606 51087    siska.bjoern@post.au.dk   
Principal Investigator: Thomas Fichtner Bendtsen, MD         
Regionshospital Silkeborg Not yet recruiting
Silkeborg, Denmark, 8600
Contact: Karen Schmøkel    +45 784 16029    karen.schmokel@rm.dk   
Principal Investigator: Jens Rolighed Larsen, MD         
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: NCT02713230     History of Changes
Other Study ID Numbers: 402-C-327
Study First Received: March 15, 2016
Last Updated: April 28, 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