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PECS II Block and Single Port Robot-assisted Transaxillary Thyroidectomy

Primary Purpose

Thyroid Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pectoral nerve block
Sponsored by
Min Suk Chae
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Cancer

Eligibility Criteria

19 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients aged 19 to 60 years who are scheduled to undergo single-port robot thyroidectomy (lobectomy or total thyroidectomy) Patients with cancer stages T1 or T2 (less than 4 cm without invasion of surrounding tissue) when thyroid cancer is suspected in the preoperative examination Patients with nodules with a maximum length of less than 4 cm based on ultrasonography if thyroid cancer is not suspected in the preoperative examination Patients with a BMI greater than or equal to 18.5 and less than 30.0. Exclusion Criteria: Patients requiring lateral cervical lymph node dissection pregnant women Uncontrolled diabetes Chronic kidney failure Patients with previous neck surgery Patients with Graves' disease People with chronic alcoholism Patients with vocal cord paralysis before surgery Severe obese patients with a body mass index >35 kg/m2 Patients participating in another clinical trial within 30 days Patients who expect that it will be difficult for medical staff to fill out the questionnaire on their own Patients whose medical staff determines that participation in the study is difficult due to other underlying diseases

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    PECS II block group

    No PECS II block group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Analgesic efficacy
    Visual analog scale

    Secondary Outcome Measures

    Quality of postoperative surgery course
    The Korean version of QoR-15 (QoR-15K questionnaire)

    Full Information

    First Posted
    October 19, 2023
    Last Updated
    October 19, 2023
    Sponsor
    Min Suk Chae
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06101043
    Brief Title
    PECS II Block and Single Port Robot-assisted Transaxillary Thyroidectomy
    Official Title
    Study on the PECS II Block With Postoperative Pain in Patients Undergoing Single Port Robot-assisted Transaxillary Thyroidectomy: Double-blinded Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2, 2023 (Anticipated)
    Primary Completion Date
    September 28, 2024 (Anticipated)
    Study Completion Date
    September 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Min Suk Chae

    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 da Vinci robotic system was developed to improve both operative maneuverability (through multi-articulated instruments) and the surgical view (via a three-dimensional camera). Although the system has many advantages, skin incision, wide flap dissection, and pneumatic/mechanical retraction remain essential, but cause postoperative pain and slower recovery. Previous studies found that pectoralis fascial blocks were easy to establish; local anesthetics are injected between two adjacent myofascial layers under ultrasound guidance, providing the surgeon with a clear image. Analgesic efficacy has been validated during robotic thyroidectomy in our institution. The pain outcomes were comparable between the groups, but there were fewer complications in the PECS II group. We investigated whether this block can reduce postoperative pain during wide flap dissection for single-port robot-assisted transaxillary thyroidectomy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Thyroid Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    76 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    PECS II block group
    Arm Type
    Experimental
    Arm Title
    No PECS II block group
    Arm Type
    No Intervention
    Intervention Type
    Procedure
    Intervention Name(s)
    Pectoral nerve block
    Intervention Description
    An ultrasound probe was placed obliquely over the second and third ribs below the lateral one-third of the clavicle. After identification of the anatomical structures, the needle was advanced along a superior-medial-to-inferior-lateral passage to the tissue plane between the pectoralis minor and serratus anterior muscles, and 20 mL ropivacaine (0.375% w/v) was injected at the level of the third rib. The anesthetic spread around the axilla, and the needle was withdrawn to the point in the plane between the pectoralis major and minor muscles. A second injection of 20 mL ropivacaine (0.375% w/v) was then delivered (PECS II).
    Primary Outcome Measure Information:
    Title
    Analgesic efficacy
    Description
    Visual analog scale
    Time Frame
    the day after surgery
    Secondary Outcome Measure Information:
    Title
    Quality of postoperative surgery course
    Description
    The Korean version of QoR-15 (QoR-15K questionnaire)
    Time Frame
    the day after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients aged 19 to 60 years who are scheduled to undergo single-port robot thyroidectomy (lobectomy or total thyroidectomy) Patients with cancer stages T1 or T2 (less than 4 cm without invasion of surrounding tissue) when thyroid cancer is suspected in the preoperative examination Patients with nodules with a maximum length of less than 4 cm based on ultrasonography if thyroid cancer is not suspected in the preoperative examination Patients with a BMI greater than or equal to 18.5 and less than 30.0. Exclusion Criteria: Patients requiring lateral cervical lymph node dissection pregnant women Uncontrolled diabetes Chronic kidney failure Patients with previous neck surgery Patients with Graves' disease People with chronic alcoholism Patients with vocal cord paralysis before surgery Severe obese patients with a body mass index >35 kg/m2 Patients participating in another clinical trial within 30 days Patients who expect that it will be difficult for medical staff to fill out the questionnaire on their own Patients whose medical staff determines that participation in the study is difficult due to other underlying diseases
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Min Suk Chae, MD, PhD
    Phone
    82-2-2258-6150
    Email
    shscms@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kwangsoon Kim, MD, PhD
    Phone
    82-2-2258-6784
    Email
    noar99@naver.com

    12. IPD Sharing Statement

    Learn more about this trial

    PECS II Block and Single Port Robot-assisted Transaxillary Thyroidectomy

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