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Local Anesthetic for Total Mastectomy Surgery

Primary Purpose

Breast Pain

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Local Anesthetic Injection above the serratus anterior
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Pain

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Undergoing elective or urgent, primary, unilateral mastectomy with or without axillary lymph node dissection
  • ASA-PS I-III
  • 18-85 years of age, inclusive
  • 50-100 kg, inclusive
  • BMI 18 - 40

Exclusion Criteria:

  • Bilateral mastectomy surgery
  • Revision mastectomy surgery
  • Inability or refusal to provide informed consent
  • Chronic pain state
  • Neuropathic pain
  • Opioid dependence
  • Allergy to local anesthesia
  • Allergy to opioids

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Local Anesthetic Injection

    Control Arm

    Arm Description

    The intervention involves injection of local anesthetic (0.25% bupivacaine with 1:200,000 epinephrine) under direct vision in the serratus anterior muscle plane at the end of surgery. Local Anesthetic Injection above the serratus anterior

    Retrospective control group who have not had the new injection technique.

    Outcomes

    Primary Outcome Measures

    Change in subjective Visual Analogue Scale (VAS)
    The visual analogue scale is administered at different time points

    Secondary Outcome Measures

    Patient Adverse Event Outcomes
    The visual analogue scale is administered at different time points

    Full Information

    First Posted
    August 5, 2016
    Last Updated
    September 1, 2016
    Sponsor
    University Health Network, Toronto
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02893384
    Brief Title
    Local Anesthetic for Total Mastectomy Surgery
    Official Title
    Analgesic Effects of Local Anesthetic Serratus Plane Infiltration for Total Mastectomy Surgery: A Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2016 (undefined)
    Primary Completion Date
    December 2016 (Anticipated)
    Study Completion Date
    December 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Health Network, Toronto

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Pain following mastectomy surgery for breast cancer can be significant. Poorly managed pain in the immediate time-period following surgery can potentially lead to long-term (chronic) pain conditions. There is still a need to find the safest, least invasive, and most effective method to manage this pain. The investigators believe that a new technique of injecting local anesthesia (freezing) in to specific areas at the end of mastectomy surgery may be a very important step to managing pain after breast surgery. The investigators would like to begin by performing a pilot study, meaning the investigators will perform the technique in patients and compare what their pain outcomes are to patients who have not had the technique.
    Detailed Description
    Mastectomy is associated with significant acute postoperative pain. It has been shown that inadequately managed post-mastectomy pain in breast cancer patients can have detrimental physiological, psycho-behavioural, recovery and healthcare utilization consequences. Most significantly, acute postoperative pain appears to be a substantial risk factor for progression to chronic post-surgical pain (CPSP), occurring in up to 68% of patients,, with higher severity of acute pain being linked with a greater progression to CPSP. A multimodal analgesic approach is the optimal method of reducing the risk of progression to CPSP, and there are a number of analgesic techniques that can be used to reduce the incidence of acute postoperative pain. Of the analgesic techniques used, the most common are multimodal systemic analgesia, thoracic paravertebral blockade, thoracic epidural analgesia, local anesthetic wound infiltration, and more recently pecs blocks and serratus plane blocks. The former three techniques are all associated with drawbacks including technical challenges, high risk of adverse effects, and limited evidence to minimize the progression to CPSP states, whilst local anesthetic wound infiltration has highly variable pain outcomes. Therefore, an alternative, safer, and more effective technique would be ideal. Local infiltration analgesia (LIA) techniques have been demonstrated to be efficacious in joint surgery, whilst injection of local anesthesia in the serratus plane to target some of the intercostal and pectoral nerves may have some benefit in mastectomy surgery. However, nobody has yet performed LIA around these nerves in breast surgery, and the investigators feel that this has enormous potential.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Pain

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Local Anesthetic Injection
    Arm Type
    Experimental
    Arm Description
    The intervention involves injection of local anesthetic (0.25% bupivacaine with 1:200,000 epinephrine) under direct vision in the serratus anterior muscle plane at the end of surgery. Local Anesthetic Injection above the serratus anterior
    Arm Title
    Control Arm
    Arm Type
    No Intervention
    Arm Description
    Retrospective control group who have not had the new injection technique.
    Intervention Type
    Drug
    Intervention Name(s)
    Local Anesthetic Injection above the serratus anterior
    Other Intervention Name(s)
    Injection to serratus anterior muscle at the end of surgery
    Intervention Description
    This is a quantitative pilot study assessing whether a new technique of local anesthesia injection during mastectomy surgery gives better pain outcomes than the standard methods. Patients who meet inclusion criteria will be invited to partake and all patients will have the injection technique. These patients will then be monitored for pain outcomes up to 7 days following the surgery and the results compared with historical results from patients who have already had the surgery.
    Primary Outcome Measure Information:
    Title
    Change in subjective Visual Analogue Scale (VAS)
    Description
    The visual analogue scale is administered at different time points
    Time Frame
    7 days after surgery
    Secondary Outcome Measure Information:
    Title
    Patient Adverse Event Outcomes
    Description
    The visual analogue scale is administered at different time points
    Time Frame
    72 hours post operatively

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Undergoing elective or urgent, primary, unilateral mastectomy with or without axillary lymph node dissection ASA-PS I-III 18-85 years of age, inclusive 50-100 kg, inclusive BMI 18 - 40 Exclusion Criteria: Bilateral mastectomy surgery Revision mastectomy surgery Inability or refusal to provide informed consent Chronic pain state Neuropathic pain Opioid dependence Allergy to local anesthesia Allergy to opioids
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rongyu Jin, MD
    Phone
    416-603-5800
    Ext
    2016
    Email
    rongyu.jin@uhn.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Vincent Chan, MD
    Organizational Affiliation
    Toronto Western Hospital, University Health Network, University of Toronto
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    publication

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    Local Anesthetic for Total Mastectomy Surgery

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