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Trial record 1 of 1 for:    402-C-409
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Phase 4, Controlled Study in Adult Subjects Undergoing Primary, 1-2 Level, Open Lumbar Spinal Fusion Surgery

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Pacira Pharmaceuticals, Inc
Sponsor:
Information provided by (Responsible Party):
Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT03015961
First received: November 14, 2016
Last updated: June 7, 2017
Last verified: June 2017
  Purpose

Primary Objective: The primary objective of this study is to compare postsurgical pain control following local infiltration analgesia (LIA) with EXPAREL admixed with bupivacaine HCl versus LIA with bupivacaine HCl in adult subjects undergoing open lumbar spinal fusion surgery.

Secondary Objectives: The secondary objectives of this study are to compare additional efficacy, safety, and health economic outcomes following LIA with EXPAREL admixed with bupivacaine HCl versus LIA with bupivacaine HCl in adult subjects undergoing open lumbar spinal fusion surgery.


Condition Intervention Phase
Postoperative Pain Management Drug: Bupivacaine HCl Drug: EXPAREL and bupivacaine HCl Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Controlled Study of EXPAREL for Postsurgical Pain Management in Subjects Undergoing Open Lumbar Spinal Fusion Surgery

Resource links provided by NLM:


Further study details as provided by Pacira Pharmaceuticals, Inc:

Primary Outcome Measures:
  • The AUC of the VAS pain intensity scores from 12-48 hours [ Time Frame: 12-48 hours ]
    The AUC of the VAS pain intensity scores from 12-48 hours


Secondary Outcome Measures:
  • Proportion of subjects who are pain free (defined as a VAS pain intensity score of ≤1.5 and no prior rescue medication) at each assessed timepoint [ Time Frame: 72 hours ]
  • The AUC of the VAS pain intensity scores through 24, 36, 48, 60, and 72 hours [ Time Frame: 72 hours ]
  • The AUC of the VAS pain intensity scores from 24-48 and 48-72 hours [ Time Frame: 72 hours ]
  • The sum of the pain intensity scores (SPIS) through 24, 48, and 72 hours [ Time Frame: 72 hours ]
  • SPIS from 24-48 and 48-72 hours [ Time Frame: 72 hours ]
  • Total inpatient postsurgical opioid consumption (in mg) through 24 and 72 hours and hospital discharge [ Time Frame: 72 hours ]
  • Total postsurgical opioid consumption (in mg) from hospital discharge through Day 30 [ Time Frame: 30 days ]
  • Percentage of opioid-free subjects through 24, 48, and 72 hours or hospital discharge [ Time Frame: 72 hours ]
  • Time to first opioid rescue through 72 hours or hospital discharge [ Time Frame: 72 hours ]
  • Incidence of the following opioid-related AEs until the discharge order is written: respiratory depression, hypoventilation, hypoxia, dry mouth, nausea, vomiting, constipation, altered mental status, pruritus, urinary retention, and postoperative ileus [ Time Frame: 30 days ]
  • The OBAS total score at 24, 48, and 72 hours [ Time Frame: 72 hours ]
  • Pain interference at Day 1 Pre-op and Day 14 [ Time Frame: 14 Days ]
  • Nurse's satisfaction with overall analgesia at 24, 48, and 72 hours or upon hospital discharge [ Time Frame: 72 hours ]
  • total opioid consumption (in IV morphine equivalents) from 0-48 hours [ Time Frame: 48 hours ]
    total opioid consumption (in IV morphine equivalents) from 0-48 hours


Estimated Enrollment: 220
Study Start Date: November 2016
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: EXPAREL admixed with bupivacaine HCl Drug: Bupivacaine HCl

Drug: Bupivacaine Single dose of bupivacaine HCl 0.5%

Other Name: bupivacaine HCl

Drug: EXPAREL and bupivacaine HCl

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

Placebo Comparator: bupivacaine HCl Drug: Bupivacaine HCl

Drug: Bupivacaine Single dose of bupivacaine HCl 0.5%

Other Name: bupivacaine HCl


  Show Detailed Description

  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. Primary surgical indication is lumbar pain, radiculopathy, disc degeneration, disc herniation, foraminal stenosis, or 1-2 level spondylolisthesis or deformity.
  3. Scheduled to undergo primary, 1-2 level, open spine fusion under general anesthesia.
  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, or transdermal, contraceptive approved by the FDA for greater than 2 months prior to screening. All women of childbearing potential (ie, premenopausal without permanent sterilization) must 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. Serious spinal conditions (to include cauda equina syndrome, infection, tumor, fracture, or severe osteoporosis [i.e., if taking Bisphosphonate or TNF-α blockers]).
  3. Previous spinal surgery at the same level other than microdiscectomy (e.g., laminectomy, fusion).
  4. Planned concurrent surgical procedure.
  5. Identification of a dural tear during surgery will be an intra-operative exclusion unless it is well repaired (no evidence of CSF leak with Valsalva and no plan to restrict activity post-operatively). Any injury to the nerve root occurring during surgery will also be considered an intra-operative exclusion.
  6. 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 spinal surgery and which may confound the postsurgical assessments.
  7. Comorbidity impacting current physical function or Investigator opinion that it may impact postsurgical rehabilitation.
  8. Allergy, hypersensitivity, or contraindication to any of the study medications (i.e., bupivacaine, oxycodone, morphine, hydromorphone, gabapentin, acetaminophen, celecoxib, or cyclobenzaprine) for which an alternative medication is not provided in the protocol.
  9. Use of any of the following medications within the times specified before surgery: long-acting opioid medication (eg, morphine including MS Contin®, hydromorphone [Dilaudid®], oxycodone [Oxycontin®], methadone) daily for more than 3 months duration or within 3 days of surgery or NSAIDs (except for low-dose aspirin used for cardioprotection) within 3 days, or any opioid medication within 24 hours. Patients receiving short-acting opioids or NSAIDs should be at a steady or plateau dose. Such patients should require or receive no more than 20 morphine equivalents (eg, 4 Percocet) within 24 hours of surgery.
  10. 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), 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. Gabapentin (Neurotin) or pregabalin (Lyrica) is permitted pre-operatively if the duration has been less than 12 weeks.
  11. Current use of systemic glucocorticosteroids within 1 month of enrollment in this study.
  12. Use of dexmedetomidine HCl (Precedex) within 3 days of study drug administration.
  13. History of coronary or vascular stent placed within the past 3 months (may be extended to 1 year if medically indicated per physician discretion).
  14. 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).
  15. Severely impaired renal (e.g., serum creatinine clearance ≤ 30) or hepatic function (e.g., serum AST level >3 x ULN or serum ALT level >3 x 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. Dependence or chronic opioid use will be defined as use of more than 30 morphine equivalents per day during the prior 90 days.
  19. Failure to pass the urine drug screen or alcohol breath test.
  20. Body weight <50 kg (110 pounds) or a body mass index >40 kg/m2.
  21. Subjects receiving Worker's compensation for a disability or who are involved in litigation.
  22. Previous participation in an EXPAREL study.
  23. 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: NCT03015961

Contacts
Contact: Jeff Hammond, MD, MPH, FACS 973-254-3564 jeff.hammond@pacira.com
Contact: Jane Kim 973-451-4063 Jane.Kim@pacira.com

Locations
United States, Arizona
OrthoArizona Recruiting
Gilbert, Arizona, United States, 85295
Contact: April Mendoza    480-889-1211    a.mendoza@prgresearch.com   
Principal Investigator: Edward Song, MD         
St. Joseph's Hospital Recruiting
Phoenix, Arizona, United States, 85013
Contact: Jill Danielson    602-406-6335    Jill.Danielson@dignityhealth.org   
Principal Investigator: Steven Chang, MD         
United States, California
UC Davis Recruiting
Sacramento, California, United States, 95817
Contact: Nancy Rudisill    916-734-3660    narudisill@ucdavis.edu   
Principal Investigator: Kee Kim, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Gi Hye Im    617-724-1509    GIM@mgh.harvard.edu   
Principal Investigator: Thomas Cha, MD         
United States, Michigan
Beaumont Health Recruiting
Troy, Michigan, United States, 48085
Contact: Kelly Slade    248-551-0194    Kelly.slade@beaumont.org   
Principal Investigator: Richard Easton, MD         
United States, Missouri
Washington Univ Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Colleen Peters    314-747-2994    petersc@wudosis.wustl.edu   
Principal Investigator: Luke Zebala, MD         
United States, New Jersey
Pacira Pharmaceuticals - Sponsor Recruiting
Parsippany, New Jersey, United States, 07054
Contact: Jeff Hammond, MD, MPH, FACS    +1 (973) 254-3564      
United States, North Carolina
OrthoCarolina Recruiting
Charlotte, North Carolina, United States, 28207
Contact: Melissa Huag    704-323-3653    Melissa.Haug@orthocarolina.com   
Principal Investigator: Alden Milam, MD         
United States, Ohio
Ohio State Univ Recruiting
Columbus, Ohio, United States, 43210
Contact: Angela Sipes    614-293-3559    angela.sipes@osumc.edu   
Principal Investigator: Sergio Bergese, MD         
United States, Pennsylvania
Thomas Jefferson University of Neurosurgery Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Kara Pigott    215-503-9110    Kara.Pigott@jefferson.edu   
Principal Investigator: Jack Jallo, MD         
United States, Texas
Central Texas Spine Institute Recruiting
Austin, Texas, United States, 78731
Contact: Rebecca Pyle    512-345-8900    rpyle@scrtrials.com   
Principal Investigator: Randall Dryer, MD         
Baylor Scott & White Recruiting
Temple, Texas, United States, 76508
Contact: Gabriela Gonzales    254-724-9292    Gabriela.Gonzales@BSWHealth.org   
Principal Investigator: Christopher Chaput, MD         
United States, Virginia
Univ of Virginia Recruiting
Charlottesville, Virginia, United States, 22903
Contact: Jennifer De Jong    434-243-9986    JAD5YC@hscmail.mcc.virginia.edu   
Principal Investigator: Chun-Po Yen, MD         
Sponsors and Collaborators
Pacira Pharmaceuticals, Inc
Investigators
Study Director: Jeff Hammond, MD Pacira Pharmaceuticals, Inc
  More Information

Responsible Party: Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT03015961     History of Changes
Other Study ID Numbers: 402-C-409
Study First Received: November 14, 2016
Last Updated: June 7, 2017
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
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 June 23, 2017