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Impact of Novel Thoracic Wall Blocks With Dexmetomidine on Inflammatory Markers Following Breast Cancer Surgery

Primary Purpose

Inflammatory Markers

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Modified pectoralis block (PEC II) and pecto-intercostal fascial plane block (PIFB)
Sponsored by
St. Elizabeth Cancer Institute, Slovakia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammatory Markers focused on measuring PEC II, PIFB, breast cancer, NLR

Eligibility Criteria

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

Inclusion Criteria:

  • Female patients with ductal carcinoma (stage 1 to 3) undergoing primary potentially curative unilateral mastectomy.
  • Older than 18 years
  • ASA I-III

Exclusion Criteria:

  • Weight < 50 kg
  • BMI > 35
  • Allergy to local anaesthetic or dexmetomidine
  • Contraindications to NSAIDs use
  • Local infection over block site
  • Coagulopathy
  • Preexisting chronic pain
  • Pregnancy
  • Autoimmune disease
  • Inability to give informed consent

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Block group

    Control group

    Arm Description

    Patients in a Block group will be anesthetized and receive PECS II+PIFB with dexmetomidine prior to their surgery.

    Patients in a Control group will receive a standard general anesthesia the same way as patients in the interventional group but without regional anesthesia.

    Outcomes

    Primary Outcome Measures

    Difference in NLR
    Difference in neutrophil-lymphocyte ratio (NLR) between the intervention group and the standard care group measured at 24 hours after breast cancer surgery

    Secondary Outcome Measures

    Markers of inflammation
    Difference in Δ NLR, PLR, NPR, PDW, MPV and RDW between the intervention group and the standard care group measured at 24 hours after breast cancer surgery
    Intraoperative opioids
    Intraoperative consumption of opioids
    Pain after surgery
    Numeric rating scale for pain (NRS, 0-10, where 0 means no pain and 10 the worst pain) at 0, 1h, 6h, 12h,18h,24h after surgery at rest and at ipsilateral arm abduction
    Opioid consumption
    Total opioid consumption after surgery at 24 h

    Full Information

    First Posted
    April 21, 2021
    Last Updated
    September 27, 2021
    Sponsor
    St. Elizabeth Cancer Institute, Slovakia
    Collaborators
    F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica, Louis Pasteur University Hospital Kosice
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04860115
    Brief Title
    Impact of Novel Thoracic Wall Blocks With Dexmetomidine on Inflammatory Markers Following Breast Cancer Surgery
    Official Title
    Impact of Novel Thoracic Wall Blocks With Dexmetomidine on Inflammatory Markers Following Breast Cancer Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2021 (Anticipated)
    Primary Completion Date
    November 1, 2023 (Anticipated)
    Study Completion Date
    December 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    St. Elizabeth Cancer Institute, Slovakia
    Collaborators
    F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica, Louis Pasteur University Hospital Kosice

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The study will test the hypothesis that inflammatory markers measured at 24 hours after breast cancer surgery will be lower in patients receiving PECS II and PIFB blocks, supplemented with dexmetomidine compared to standard care group.
    Detailed Description
    Breast cancer is a devastating disease. Surgery is the mainstay of treatment which can lead to ongoing patient difficulties. Severe acute pain after surgery is one of major risk factors for developing persistent postsurgical pain. Subsequent physiological stress caused by this severe pain may negatively influence the immune response leading to a worse prognosis. Regional anesthesia is very effective in management of peri- and postoperative pain. Epidural block, paravertebral block and intercostal nerve blocks have been proven over time to be effective in preventing postoperative pain. However, their widespread use has been hampered by technical difficulty and inherent risks. Unlike the aforementioned blocks, novel thoracic wall blocks, namely modified pectoralis block (PECS II) and pecto-intercostal fascial block (PIFB) are safe, simple and effective. Efforts to prolong and improve analgesia following single shot blocks has led to the introduction of adjuvants into the local anesthetic. Dexmetomidine is a superselective Alpha 2 agonist with a proven ability to prolong the duration of neuraxial, peripheral nerve and interfascial plane blocks. Chronic inflammation is recognized as a risk factor for initiation, progression and further spread of malignant growth. Surgical insult leads to inflammatory response which facilitates the development of a metastatic disease. Many inflammatory markers were proven to be independent prognostic factors in breast cancer patients. The investigators propose to study the impact of novel thoracic wall blocks with dexmetomidine on simple inflammatory markers obtained from full blood count (NLR, PLR, NPR, PDW, MPV, RDW) after breast cancer surgery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Inflammatory Markers
    Keywords
    PEC II, PIFB, breast cancer, NLR

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    120 patients randomized into two groups of 60 patients. Group B (PECS II+PIFB with dexmetomidine) and Group C (control).
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    Intervention will be done under general anesthesia so participant will be blinded and primary outcome which will be laboratory test will be assessed by a person not aware of intervention.
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Block group
    Arm Type
    Experimental
    Arm Description
    Patients in a Block group will be anesthetized and receive PECS II+PIFB with dexmetomidine prior to their surgery.
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    Patients in a Control group will receive a standard general anesthesia the same way as patients in the interventional group but without regional anesthesia.
    Intervention Type
    Procedure
    Intervention Name(s)
    Modified pectoralis block (PEC II) and pecto-intercostal fascial plane block (PIFB)
    Intervention Description
    PECS II: Ultrasound guided block involving injection of 20 ml of 0.25% L-bupivacaine with dexmetomidine into an interfascial plane between the serratus anterior muscle and the external intercostal muscles followed by the needle withdrawal into an interfascial plane between the pectoralis major and pectoralis minor muscle where further 10ml will be administered. PIFB: Ultrasound guided block involving injection of 10 ml of 0.25% L-bupivacaine with dexmetomidine into an iterfascial plane between the pectoralis major and the intercostal muscles approximately 2 cm laterally from the sternum to cover T2 to T6 dermatomes.
    Primary Outcome Measure Information:
    Title
    Difference in NLR
    Description
    Difference in neutrophil-lymphocyte ratio (NLR) between the intervention group and the standard care group measured at 24 hours after breast cancer surgery
    Time Frame
    24 hours after surgery
    Secondary Outcome Measure Information:
    Title
    Markers of inflammation
    Description
    Difference in Δ NLR, PLR, NPR, PDW, MPV and RDW between the intervention group and the standard care group measured at 24 hours after breast cancer surgery
    Time Frame
    24 hours after surgery
    Title
    Intraoperative opioids
    Description
    Intraoperative consumption of opioids
    Time Frame
    Duration of surgery
    Title
    Pain after surgery
    Description
    Numeric rating scale for pain (NRS, 0-10, where 0 means no pain and 10 the worst pain) at 0, 1h, 6h, 12h,18h,24h after surgery at rest and at ipsilateral arm abduction
    Time Frame
    1,6,12,18,24 hours after surgery
    Title
    Opioid consumption
    Description
    Total opioid consumption after surgery at 24 h
    Time Frame
    24 hours
    Other Pre-specified Outcome Measures:
    Title
    Adverse effects
    Description
    Incidence of potential adverse effects
    Time Frame
    24 hours
    Title
    Postsurgical pain
    Description
    Incidence of postsurgical pain at 1month, 2month and 3 months
    Time Frame
    3 months after surgery

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Female patients with ductal carcinoma (stage 1 to 3) undergoing primary potentially curative unilateral mastectomy. Older than 18 years ASA I-III Exclusion Criteria: Weight < 50 kg BMI > 35 Allergy to local anaesthetic or dexmetomidine Contraindications to NSAIDs use Local infection over block site Coagulopathy Preexisting chronic pain Pregnancy Autoimmune disease Inability to give informed consent
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tomas Hitka, MD
    Phone
    00421902753979
    Email
    hitka@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Roman Zahorec, MD
    Phone
    00421 2 32249210
    Email
    roman.zahorec@ousa.sk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tomas Hitka, MD
    Organizational Affiliation
    St. Elizabeth Cancer Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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    Impact of Novel Thoracic Wall Blocks With Dexmetomidine on Inflammatory Markers Following Breast Cancer Surgery

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