Phase 4, Controlled Study in Adult Subjects Undergoing Primary, 1-2 Level, Open Lumbar Spinal Fusion Surgery

NCT03015961 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: 402-C-409
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 15

Brief Summary

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 posterior 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 posterior spinal fusion surgery.

Conditions

Postoperative Pain Management

Outcome Measures

Primary Outcomes (1)

• Area Under the Curve (AUC) of Visual Analog Scale (VAS) Pain Intensity Scores From 0 to 72 Hours

  AUC of VAS pain intensity scores from 0 to 72 hours postsurgery. Visual Analog Scale (VAS) is a pain scale. The VAS was presented as a straight 10 cm line, where 0 cm is no pain and 10 cm is the worst pain possible. Patients were asked, "How much pain are you experiencing right now? Please place a vertical mark on the line below to indicate the level of pain you are experiencing right now." AUC curve is derived using the trapezoidal rule (see formula below) on the pain scores. AUC start with the first pain assessment obtained after surgery and use all subsequent pain assessments up to 72 hours post-surgery. (Where pi is the VAS pain score at time i and ti is the time, in hours, from end of surgery. Note t1 is pain score collected after surgery.)

  0-72 hours

Other Outcomes (3)

• Percentage of Opioid-Free Patients

  0-24, 0-48, 0-72 hours

• Area Under the Curve (AUC) of the Visual Analog Scale (VAS) Pain Intensity Scores From 24-48 and 48-72 Hours Postsurgery

  24-48 hours, 48-72 hours

• Total Opioid Consumption Through 48 Hours Postsurgery

  0-48 hours

Study Arms (2)

EXPAREL admixed with bupivacaine HCl

ACTIVE COMPARATOR

EXPAREL 266 mg + bupivacaine HCl

Drug: EXPAREL and bupivacaine HCl

Bupivacaine HCl

PLACEBO COMPARATOR

Bupivacaine HCl

Drug: Bupivacaine HCl

Interventions

EXPAREL and bupivacaine HCl DRUG

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

EXPAREL admixed with bupivacaine HCl

Bupivacaine HCl DRUG

Drug: Bupivacaine Single dose of bupivacaine HCl 0.5% Other Name: bupivacaine HCl

Bupivacaine HCl

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, at least 18 years of age at screening.
• Primary surgical indication is lumbar pain, radiculopathy, disc degeneration, disc herniation, foraminal stenosis, or 1-2 level spondylolisthesis or deformity.
• Scheduled to undergo primary, 1-2 level, open lumbar spinal fusion surgery under general anesthesia.
• American Society of Anesthesiologists (ASA) physical status 1, 2, or 3.
• 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.
• Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments.

You may not qualify if:

• Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after study drug administration.
• Serious spinal conditions (to include cauda equina syndrome, infection, tumor, fracture, or severe osteoporosis \[ie, if taking Bisphosphonate or TNF-α blockers\]).
• Planned anterior or lateral incisions
• Previous spinal surgery at the same level other than microdiscectomy or hemilaminectomy (eg, bi-lateral laminectomy, fusion).
• Planned concurrent surgical procedure.
• 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.
• Comorbidity impacting current physical function or Investigator opinion that it may impact postsurgical rehabilitation.
• Allergy, hypersensitivity, or contraindication to any of the study medications (ie, bupivacaine, oxycodone, morphine, hydromorphone, gabapentin, acetaminophen, or cyclobenzaprine) for which an alternative medication is not provided in the protocol.
• 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. Patients receiving short-acting opioids or NSAIDs should be at a steady or plateau dose. Such patients should require or receive no more than 40 mg morphine (oral) equivalents (eg, approximately 5 mg oxycodone) within 24 hours of surgery.
• 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.
• Current use of systemic glucocorticosteroids within 1 month of enrollment in this study.
• Use of dexmedetomidine HCl (Precedex®) within 3 days of study drug administration.
• History of coronary or vascular stent placed within the past 3 months (may be extended to 1 year if medically indicated per physician discretion).
• 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).
• Severely impaired renal (eg, serum creatinine clearance ≤ 30) or hepatic function (eg, serum aspartate aminotransferase \[AST\] level \>3 times the upper limit of normal \[ULN\] or serum alanine aminotransferase \[ALT\] level \>3 x ULN).

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead

Study Sites (15)

OrthoArizona

Gilbert, Arizona, 85295, United States

Location

St. Joseph's Hospital

Phoenix, Arizona, 85013, United States

Location

UC Davis

Sacramento, California, 95817, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beaumont Health

Troy, Michigan, 48085, United States

Location

Washington Univ

St Louis, Missouri, 63110, United States

Location

Icahn School of Medicine

New York, New York, 10029, United States

Location

OrthoCarolina

Charlotte, North Carolina, 28207, United States

Location

Ohio State Univ

Columbus, Ohio, 43210, United States

Location

Thomas Jefferson University of Neurosurgery

Philadelphia, Pennsylvania, 19107, United States

Location

Central Texas Spine Institute

Austin, Texas, 78731, United States

Location

Baylor Scott & White

Temple, Texas, 76508, United States

Location

Univ of Virginia

Charlottesville, Virginia, 22903, United States

Location

Colonial Orthopaedics

Colonial Heights, Virginia, 23834, United States

Location

West Virginia University Hospitals

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Limitations and Caveats

This study was terminated early due to low enrollment; small sample sizes make data interpretation difficult.

Results Point of Contact

• Title: Pacira Medical Information
• Organization: Pacira Pharmaceuticals, Inc.

MedInfo@pacira.com

1-855-793-9727

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2016
• First Posted: January 10, 2017
• Study Start: February 21, 2017
• Primary Completion: October 30, 2017
• Study Completion: October 30, 2017
• Last Updated: October 13, 2021
• Results First Posted: October 13, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)