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EXPAREL Administered Into the TAP for Analgesia in Subjects Undergoing Open Total Abdominal Hysterectomy

Primary Purpose

Postoperative Pain

Status
Terminated
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
EXPAREL
Sponsored by
Pacira Pharmaceuticals, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring hysterectomy, analgesia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Females, 18-75 years of age inclusive.
  • American Society of Anesthesiologist (ASA) physical status 1-3.
  • Undergoing open total abdominal hysterectomy (i.e., laparoscopic procedures are not sufficient) without any concurrent surgical procedure(s).
  • Physically and mentally able to participate in the study and complete all study assessments.
  • Able to give fully informed consent to participate in this study after demonstrating a good understanding of the risks and benefits of the TAP.

Exclusion Criteria:

  • Demonstrated hypersensitivity or idiosyncratic reactions to amide-type local anesthetics.
  • Any subject whose anatomy, or surgical procedure, in the opinion of the Investigator, might preclude the potential successful performance of a TAP.
  • Any subject who in the opinion of the Investigator might be harmed or be a poor candidate for participation in the study.
  • Any subject, who in the opinion of the Investigator, is on chronic pain medicine.
  • Subjects who have received any investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during their participation in this study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    EXPAREL Group 1

    EXPAREL Group 2

    Arm Description

    EXPAREL 266 mg diluted with saline to a volume of 40 mL

    EXPAREL 266 mg diluted with saline to a volume of 60 mL

    Outcomes

    Primary Outcome Measures

    Duration of Analgesia

    Secondary Outcome Measures

    Incidence of Adverse Events

    Full Information

    First Posted
    February 26, 2013
    Last Updated
    February 11, 2021
    Sponsor
    Pacira Pharmaceuticals, Inc
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01919606
    Brief Title
    EXPAREL Administered Into the TAP for Analgesia in Subjects Undergoing Open Total Abdominal Hysterectomy
    Official Title
    Evaluation of the Safety and Efficacy of EXPAREL(R) (Bupivacaine Liposome Injectable Suspension) When Administered Into the Transversus Abdominis Plane (TAP) for Prolonged Postoperative Analgesia in Subjects Undergoing Open Total Abdominal Hysterectomy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2021
    Overall Recruitment Status
    Terminated
    Why Stopped
    Lack of enrollment
    Study Start Date
    August 2012 (undefined)
    Primary Completion Date
    October 2012 (Actual)
    Study Completion Date
    October 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Pacira Pharmaceuticals, Inc

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The primary objective of this study is to determine the optimal of two different volumes of EXPAREL 266 mg when administered via infiltration into the transversus abdominis plane (TAP) for prolonged postoperative analgesia in subjects undergoing open total abdominal hysterectomy.
    Detailed Description
    This is a prospective, open-label, non-randomized study with two treatment groups differing only in the volume of EXPAREL infiltrated into the TAP. All subjects will undergo an open total abdominal hysterectomy. The dose of EXPAREL for the TAPs will be the same for all 20 subjects, 133 mg on the right side of the abdomen and 133 mg on the left side of the abdomen.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Pain
    Keywords
    hysterectomy, analgesia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    1 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    EXPAREL Group 1
    Arm Type
    Experimental
    Arm Description
    EXPAREL 266 mg diluted with saline to a volume of 40 mL
    Arm Title
    EXPAREL Group 2
    Arm Type
    Experimental
    Arm Description
    EXPAREL 266 mg diluted with saline to a volume of 60 mL
    Intervention Type
    Drug
    Intervention Name(s)
    EXPAREL
    Other Intervention Name(s)
    Bupivacaine liposome injectable suspension
    Intervention Description
    Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively.
    Primary Outcome Measure Information:
    Title
    Duration of Analgesia
    Time Frame
    End of surgery to time of subject's first postsurgical opioid administration (through 72 hours)
    Secondary Outcome Measure Information:
    Title
    Incidence of Adverse Events
    Time Frame
    10 days post surgery plus or minus 3 days

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Females, 18-75 years of age inclusive. American Society of Anesthesiologist (ASA) physical status 1-3. Undergoing open total abdominal hysterectomy (i.e., laparoscopic procedures are not sufficient) without any concurrent surgical procedure(s). Physically and mentally able to participate in the study and complete all study assessments. Able to give fully informed consent to participate in this study after demonstrating a good understanding of the risks and benefits of the TAP. Exclusion Criteria: Demonstrated hypersensitivity or idiosyncratic reactions to amide-type local anesthetics. Any subject whose anatomy, or surgical procedure, in the opinion of the Investigator, might preclude the potential successful performance of a TAP. Any subject who in the opinion of the Investigator might be harmed or be a poor candidate for participation in the study. Any subject, who in the opinion of the Investigator, is on chronic pain medicine. Subjects who have received any investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during their participation in this study.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Robert Dorian, MD
    Organizational Affiliation
    St. Barnabas Medical Center, Livingston, NJ 07039
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Thad Denehy, MD
    Organizational Affiliation
    St. Barnabas Medical Center, Livingston, NJ 07039
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    EXPAREL Administered Into the TAP for Analgesia in Subjects Undergoing Open Total Abdominal Hysterectomy

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