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Bupivacaine Versus Liposomal Bupivacaine For Breast Pain Management After Breast Recontruction

Primary Purpose

Breast Cancer

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Liposomal Bupivacaine
Bupivacaine
Patient-Controlled Analgesia Pump
Oral Narcotic
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Reconstruction, Bupivacaine, Liposomal Bupivacaine

Eligibility Criteria

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

Inclusion Criteria:

  • Patients scheduled to have a unilateral, immediate breast reconstruction

Exclusion Criteria:

  • Pregnant
  • Concurrent or recent medical condition that could interfere with study participation including:

    • Hepatitis
    • Alcohol/substance abuse
    • Uncontrolled psychiatric disorders
    • Known allergy
    • Contraindication to amide-type local anesthetics, opioids, or propofol.
  • Body weight of less than 50 kg
  • Participated in another study involving an investigational medication within the prior 30 days
  • Taking analgesics (i.e., nonsteroidal anti-inflammatory drugs, acetaminophen, or opioids), antidepressants, or glucocorticoids within the 3 days before surgery.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Liposomal Bupivacaine + Bupivacaine

    Bupivacaine

    Arm Description

    This group will receive a long-acting pain medicine, Liposomal Bupivacaine, injected into the breast muscles during surgery. All patients will receive patient-controlled analgesia pump and oral narcotics as indicated post surgery.

    This group will receive the same pain medication, Bupivacaine, but in the standard formulation, injected into the breast muscles during surgery. All patients will receive patient-controlled analgesia pump and oral narcotics as indicated post surgery.

    Outcomes

    Primary Outcome Measures

    total post-operative narcotic utilization
    post-operative pain as measured by total post-operative narcotic utilization standardized to milligrams of morphine.

    Secondary Outcome Measures

    at rest pain score on visual analog scale
    0-100 score of self-reported pain
    coughing pain score on visual analog scale
    0-100 score of self-reported pain
    number of incidents of nausea reported by patient
    self-report of nausea
    number of incidents of vomiting reported by patient
    number of times a patient vomits
    time to first ambulation
    time to first liquid intake
    time to first solid intake

    Full Information

    First Posted
    December 26, 2017
    Last Updated
    July 21, 2020
    Sponsor
    Case Comprehensive Cancer Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03393117
    Brief Title
    Bupivacaine Versus Liposomal Bupivacaine For Breast Pain Management After Breast Recontruction
    Official Title
    Prospective, Randomized, Blinded Comparison of Bupivacaine Versus Liposomal Bupivacaine For Breast Pain Management After Unilateral, Immediate Breast Reconstruction
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    No accrual
    Study Start Date
    March 30, 2018 (Actual)
    Primary Completion Date
    July 1, 2020 (Anticipated)
    Study Completion Date
    July 1, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Case Comprehensive Cancer Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to determine the most effective way to control post-operative breast pain for patients undergoing a unilateral, immediate breast reconstruction.
    Detailed Description
    This is a randomized controlled study to compare the effectiveness of a breast nerve block performed with bupivacaine as compared to liposomal bupivacaine in providing postsurgical analgesia in patients undergoing unilateral abdominally-based breast reconstruction at time of mastectomy. OBJECTIVES Compare the amount of postoperative narcotic use in patients receiving a bupivacaine or liposomal bupivacaine pectoralis and serratus anterior nerve block. Compare these groups to a retrospective control cohort who received local anesthetic infusion but did not receive any nerve block. Examine the incidence of narcotic-related side effects in the experimental groups by documenting incidents of nausea and vomiting, time to first ambulation, liquid and solid oral intake. Survey patient satisfaction with pain management using a visual analog scale during their hospital stay.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer
    Keywords
    Reconstruction, Bupivacaine, Liposomal Bupivacaine

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Masking Description
    Medication utilized will be blinded in the chart per inpatient pharmacy.
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Liposomal Bupivacaine + Bupivacaine
    Arm Type
    Experimental
    Arm Description
    This group will receive a long-acting pain medicine, Liposomal Bupivacaine, injected into the breast muscles during surgery. All patients will receive patient-controlled analgesia pump and oral narcotics as indicated post surgery.
    Arm Title
    Bupivacaine
    Arm Type
    Active Comparator
    Arm Description
    This group will receive the same pain medication, Bupivacaine, but in the standard formulation, injected into the breast muscles during surgery. All patients will receive patient-controlled analgesia pump and oral narcotics as indicated post surgery.
    Intervention Type
    Drug
    Intervention Name(s)
    Liposomal Bupivacaine
    Other Intervention Name(s)
    Exparel
    Intervention Description
    20mL vial of Liposomal Bupivacaine (266 mg). The infiltration technique for Liposomal Bupivacaine will be 80mL injected into either hemi-abdomen as a transversus abdominous plane (TAP) block via ultrasound guidance. The other 80mL will be utilized in the operative breast for the field blocks (20mL), pectoralis 1 (20mL), pectoralis 2 (20mL) and serratus anterior (20mL) blocks.
    Intervention Type
    Drug
    Intervention Name(s)
    Bupivacaine
    Other Intervention Name(s)
    Sensorcaine-Methyl Paraben Free (MPF) Spinal, Sensorcaine-MPF, Sensorcaine, ReadySharp Bupivacaine, P-Care M, Marcaine Spinal, Marcaine Preservative Free, Marcaine, Bupivacaine Spinal
    Intervention Description
    20mL vial of 0.25% Bupivacaine. The field blocks (20mL), pectoralis 1 (20mL), pectoralis 2 (20mL) and serratus anterior (20mL) blocks will be performed with 0.25% Bupivacaine.
    Intervention Type
    Drug
    Intervention Name(s)
    Patient-Controlled Analgesia Pump
    Other Intervention Name(s)
    intravenous narcotic
    Intervention Description
    The patient-controlled anesthesia will be filled with morphine or hydromorphone. Pumps will be programmed be on demand only with no basal rate.
    Intervention Type
    Drug
    Intervention Name(s)
    Oral Narcotic
    Intervention Description
    Oral narcotics will be offered when the patient's diet is advanced as tolerated, typically post-operative day 1.
    Primary Outcome Measure Information:
    Title
    total post-operative narcotic utilization
    Description
    post-operative pain as measured by total post-operative narcotic utilization standardized to milligrams of morphine.
    Time Frame
    Up to 72 hours post-operative
    Secondary Outcome Measure Information:
    Title
    at rest pain score on visual analog scale
    Description
    0-100 score of self-reported pain
    Time Frame
    Up to 72 hours post-operative
    Title
    coughing pain score on visual analog scale
    Description
    0-100 score of self-reported pain
    Time Frame
    Up to 72 hours post-operative
    Title
    number of incidents of nausea reported by patient
    Description
    self-report of nausea
    Time Frame
    Up to 72 hours post-operative
    Title
    number of incidents of vomiting reported by patient
    Description
    number of times a patient vomits
    Time Frame
    Up to 72 hours post-operative
    Title
    time to first ambulation
    Time Frame
    Up to 72 hours post-operative
    Title
    time to first liquid intake
    Time Frame
    Up to 72 hours post-operative
    Title
    time to first solid intake
    Time Frame
    Up to 72 hours post-operative

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients scheduled to have a unilateral, immediate breast reconstruction Exclusion Criteria: Pregnant Concurrent or recent medical condition that could interfere with study participation including: Hepatitis Alcohol/substance abuse Uncontrolled psychiatric disorders Known allergy Contraindication to amide-type local anesthetics, opioids, or propofol. Body weight of less than 50 kg Participated in another study involving an investigational medication within the prior 30 days Taking analgesics (i.e., nonsteroidal anti-inflammatory drugs, acetaminophen, or opioids), antidepressants, or glucocorticoids within the 3 days before surgery.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Risal Djohan, MD
    Organizational Affiliation
    Cleveland Clinic, Case Comprehensive Cancer Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Bupivacaine Versus Liposomal Bupivacaine For Breast Pain Management After Breast Recontruction

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