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Comparison of ESP Block Versus Serratus Block

Primary Purpose

Postoperative Pain

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
ESP block group
serratus block group
Sponsored by
Cukurova University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • ASA I-II patients
  • Being volunteer
  • Total mastectomy

Exclusion Criteria:

  • ASA III and over
  • Renal and hepatic failure
  • Non Volunteers
  • Emergency procedures

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    ESP block group

    serratus block group

    Arm Description

    Under general anaesthesia, Ultrasound guided ESP block will perform at the T6 level with15 ml bupivacain+ 5ml lidocaine, bilaterally. Morphine 0.1 mg/kg will administer at last 30 minutes of surgery for postoperative analgesia. Patient controlled analgesia (PCA) with morphine will apply to the all patients. Postoperative pain assessment and morphine consumption will record till the postoperative 24 th hours.

    Under general anaesthesia, Ultrasound guided SAP block will perform at the T6 level with15 ml bupivacain+ 5ml lidocaine, bilaterally. Morphine 0.1 mg/kg will administer at last 30 minutes of surgery for postoperative analgesia. Patient controlled analgesia (PCA) with morphine will apply to the all patients. Postoperative pain assessment and morphine consumption will record till the postoperative 24 th hours.

    Outcomes

    Primary Outcome Measures

    morphine consumption
    Patient controlled analgesia (PCA) will provide with morphine PCA. Total morphine consumption will calculate and record till the postoperative 24th hours.

    Secondary Outcome Measures

    numerical rating scale score
    Postoperative pain assessment will apply with 11-point numerical rating scale. These scores will record till the postoperative 24 th hours.

    Full Information

    First Posted
    August 2, 2018
    Last Updated
    August 6, 2018
    Sponsor
    Cukurova University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03619447
    Brief Title
    Comparison of ESP Block Versus Serratus Block
    Official Title
    Comparison of the Ultrasound Guided Erector Spinae Plane Block Versus Serratus Plane Block in Totally Mastectomy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 15, 2018 (Anticipated)
    Primary Completion Date
    March 15, 2019 (Anticipated)
    Study Completion Date
    April 15, 2019 (Anticipated)

    3. Sponsor/Collaborators

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

    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
    Total 60 patients, American society of anaesthesiology physical status I-II aged between 18-65 who underwent totally mastectomy will recruit to the study. The patients randomly divided into two groups. Ultrasound guided Erector spinae plane block (ESP) will perform with 15 ml bupivacaine+ 5 ml lidocaine in Group ESP and ultrasound guided serratus anterior plane (SAP) block will perform with 5 ml bupivacaine+ 5 ml lidocaine in Group SAP. Postoperative pain assessment will apply with 11-point numerical rating scale (NRS) and postoperative analgesic requirement will calculate and record with morphine consumption (patient controlled analgesia).
    Detailed Description
    In this study, total 60 patients, American society of anaesthesiology physical status I-II aged between 18-65 who underwent totally mastectomy will recruit. Using with computer randomisation, the patients allocate into two groups. Anaesthesia induction will perform with 2 mg/kg propofol, 0.6 mg/kg rocuronium and 2 microgram/kg fentanil and general anaesthesia will maintain with sevoflurane %1-2 +%40-60 O2-N20 mixture and remifentanil infusion. All of the blocks will perform under general anaesthesia. Ultrasound guided Erector spinae plane block (ESP) will perform with 15 ml bupivacaine+ 5 ml lidocaine in Group ESP and ultrasound guided serratus anterior plane (SAP) block will perform with 5 ml bupivacaine+ 5 ml lidocaine in Group SAP. Postoperative pain, analgesic requirement and complications will evaluate. Postoperative pain assessment will apply with 11-point numerical rating scale (NRS) and postoperative analgesic requirement will calculate and record with morphine consumption (patient controlled analgesia).

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Masking Description
    Both participants and anaesthesia provider will not know which intervention applied. Another anaesthesia provider who did not perform any block will follow and record to the study data.
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    ESP block group
    Arm Type
    Active Comparator
    Arm Description
    Under general anaesthesia, Ultrasound guided ESP block will perform at the T6 level with15 ml bupivacain+ 5ml lidocaine, bilaterally. Morphine 0.1 mg/kg will administer at last 30 minutes of surgery for postoperative analgesia. Patient controlled analgesia (PCA) with morphine will apply to the all patients. Postoperative pain assessment and morphine consumption will record till the postoperative 24 th hours.
    Arm Title
    serratus block group
    Arm Type
    Active Comparator
    Arm Description
    Under general anaesthesia, Ultrasound guided SAP block will perform at the T6 level with15 ml bupivacain+ 5ml lidocaine, bilaterally. Morphine 0.1 mg/kg will administer at last 30 minutes of surgery for postoperative analgesia. Patient controlled analgesia (PCA) with morphine will apply to the all patients. Postoperative pain assessment and morphine consumption will record till the postoperative 24 th hours.
    Intervention Type
    Drug
    Intervention Name(s)
    ESP block group
    Other Intervention Name(s)
    USG guided ESP block group
    Intervention Description
    USG guided Erector spinae block (ESP) will perform bilaterally.
    Intervention Type
    Drug
    Intervention Name(s)
    serratus block group
    Other Intervention Name(s)
    USG guided serratus plane block
    Intervention Description
    USG guided serratus plane block will perform bilaterally
    Primary Outcome Measure Information:
    Title
    morphine consumption
    Description
    Patient controlled analgesia (PCA) will provide with morphine PCA. Total morphine consumption will calculate and record till the postoperative 24th hours.
    Time Frame
    up to postoperative 24th hours.
    Secondary Outcome Measure Information:
    Title
    numerical rating scale score
    Description
    Postoperative pain assessment will apply with 11-point numerical rating scale. These scores will record till the postoperative 24 th hours.
    Time Frame
    up to postoperative 24th hours.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: ASA I-II patients Being volunteer Total mastectomy Exclusion Criteria: ASA III and over Renal and hepatic failure Non Volunteers Emergency procedures
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ebru Biricik
    Phone
    05052420223
    Email
    ebrubiricik01@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Feride Karacaer
    Phone
    05062628416
    Email
    feridekaracaer@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ebru Biricik
    Organizational Affiliation
    Cukurova University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Comparison of ESP Block Versus Serratus Block

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