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Erector Spina Plane Block vs Serratus Anterior Plane Block for Postoperative Mastectomy Pain

Primary Purpose

Mastectomy, Pain, Postoperative, Recovery Period, Anesthesia

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
serratus anterior plane block
erector spina plane block
Sponsored by
Tokat Gaziosmanpasa University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mastectomy focused on measuring Pain Management, Quality of Healthcare

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • American society of score anesthesiologist I-II-III
  • Elective modified radical mastectomy
  • 18-65 years old

Exclusion Criteria:

  • neurological disease
  • coagulopathy disease or using anticoagulants
  • non-cooperative
  • allergic to one of the drugs used in the study
  • recurrent breast cancer
  • body mass index is above 35

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    serratus anterior plane block

    erector spina plane block

    Arm Description

    The serratus anterior plane block will be performed under ultrasound guidance in the preoperative term. Tramadol will be administered via patient controlled analgesia (PCA) device at 20 mg bolus dose with 10 min. lockout time without basal infusion dose.

    The erector spina plane block will be performed under ultrasound guidance in the preoperative term. Tramadol will be administered via PCA device at 20 mg bolus dose with 10 min. lockout time without basal infusion dose.

    Outcomes

    Primary Outcome Measures

    Analgesic consumption
    Tramadol dose will be calculated as milligram

    Secondary Outcome Measures

    Postoperative pain intensity
    Numeric rating scale which is 0 to 10 will be recorded.In this scale, 0 is no pain, 10 is the worst pain.
    Quality of recovery
    Quality of recovery (QoR-40) questionaire will be recorded. The QoR-40 is a questionaire which measures of five dimensions of health: patient support, comfort, emotions, physical independence, and pain on a five-point likert scale. QoR-40 scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery)
    The number of patients with perioperative side effects
    The number of patients with perioperative side effects(emesis, nausea, local anesthetic toxicity, pneumothorax, local hematoma) will be recorded

    Full Information

    First Posted
    March 3, 2020
    Last Updated
    March 11, 2020
    Sponsor
    Tokat Gaziosmanpasa University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04296188
    Brief Title
    Erector Spina Plane Block vs Serratus Anterior Plane Block for Postoperative Mastectomy Pain
    Official Title
    Comparison of Erector Spina Plane Block and Serratus Anterior Plane Block in Patients Undergoing Mastectomy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 18, 2020 (Anticipated)
    Primary Completion Date
    February 27, 2021 (Anticipated)
    Study Completion Date
    March 15, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Tokat Gaziosmanpasa University

    4. Oversight

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

    5. Study Description

    Brief Summary
    The aim of this study is to compare the efficiency of serratus anterior plane block and erector spina plane block on analgesic consumption, postoperative pain and patient's satisfaction and recovery quality in patients undergoing mastectomy.
    Detailed Description
    Mastectomy may cause severe postoperative pain. There are several analgesic methods for postoperative pain management. Serratus anterior plane (SAP) block is an interfascial plane block which is performed into the fascial plane of serratus anterior muscle. It provides effective analgesia in anterior, posterior and lateral dermatomes of thorax. There are several studies about its analgesic efficacy for mastectomy pain. The erector spina plane (ESP) block is another novel plan block which provides analgesia at multi-dermatomal area of the anterior, posterior, and lateral thoracic and abdominal walls. There are some studies about its effectiveness for postoperative mastectomy pain management. However, according to our best knowledge, there is no literature comparing the efficacy of ESP block and SAP block patients undergoing mastectomy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mastectomy, Pain, Postoperative, Recovery Period, Anesthesia
    Keywords
    Pain Management, Quality of Healthcare

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    serratus anterior plane block
    Arm Type
    Active Comparator
    Arm Description
    The serratus anterior plane block will be performed under ultrasound guidance in the preoperative term. Tramadol will be administered via patient controlled analgesia (PCA) device at 20 mg bolus dose with 10 min. lockout time without basal infusion dose.
    Arm Title
    erector spina plane block
    Arm Type
    Active Comparator
    Arm Description
    The erector spina plane block will be performed under ultrasound guidance in the preoperative term. Tramadol will be administered via PCA device at 20 mg bolus dose with 10 min. lockout time without basal infusion dose.
    Intervention Type
    Procedure
    Intervention Name(s)
    serratus anterior plane block
    Intervention Description
    ultrasound guided serratus anterior plane block will be done with % 0.25 bupivacaine.
    Intervention Type
    Procedure
    Intervention Name(s)
    erector spina plane block
    Intervention Description
    ultrasound guided erector spina plane block will be done with % 0.25 bupivacaine.
    Primary Outcome Measure Information:
    Title
    Analgesic consumption
    Description
    Tramadol dose will be calculated as milligram
    Time Frame
    From at the end of surgery (at postoperative 0th hour) to postoperative 24th hours
    Secondary Outcome Measure Information:
    Title
    Postoperative pain intensity
    Description
    Numeric rating scale which is 0 to 10 will be recorded.In this scale, 0 is no pain, 10 is the worst pain.
    Time Frame
    At 0,2,4,6,12,24th hours after surgery
    Title
    Quality of recovery
    Description
    Quality of recovery (QoR-40) questionaire will be recorded. The QoR-40 is a questionaire which measures of five dimensions of health: patient support, comfort, emotions, physical independence, and pain on a five-point likert scale. QoR-40 scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery)
    Time Frame
    At postoperative 24th hours
    Title
    The number of patients with perioperative side effects
    Description
    The number of patients with perioperative side effects(emesis, nausea, local anesthetic toxicity, pneumothorax, local hematoma) will be recorded
    Time Frame
    From 30 minute before surgery to postoperative 24th hours

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: American society of score anesthesiologist I-II-III Elective modified radical mastectomy 18-65 years old Exclusion Criteria: neurological disease coagulopathy disease or using anticoagulants non-cooperative allergic to one of the drugs used in the study recurrent breast cancer body mass index is above 35
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    mehtap gürler balta, MD
    Phone
    +903562129500
    Ext
    3494
    Email
    drmehtapgurler@hotmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    tuğba karaman, MD
    Phone
    +903562129500
    Ext
    3498
    Email
    drtugbaguler@hotmail.com

    12. IPD Sharing Statement

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    Erector Spina Plane Block vs Serratus Anterior Plane Block for Postoperative Mastectomy Pain

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