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Transversus Thoracic Muscle Plane Combined With Pectoral Nerves Block for Breast Cancer Surgery

Primary Purpose

Breast Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
the combination of transversus thoracic muscle plane and pectoral nerves blocks
the pectoral nerves block only
Sponsored by
Zhejiang Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • female, 18-80 years of age
  • American Society of Anesthesiologists physical status I-III
  • patients having elective unilateral breast cancer surgery

Exclusion Criteria:

  • contraindication to nerve block
  • inability to understand or communicate with research personnel
  • chronic use of opioids or nonsteroidal anti-inflammatory drugs
  • pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    transversus thoracic muscle plane block+pectoral nerves block

    pectoral nerves block

    Arm Description

    the combination of transversus thoracic muscle plane and pectoral nerves blocks

    the pectoral nerves block only

    Outcomes

    Primary Outcome Measures

    the quality of recovery-15 questionnaire (QoR-15)
    The QoR-15 is a validated short-form postoperative quality of recovery score. Fifteen questions assess five domains of patient health-related quality of life: pain; comfort; physical independence; psychological support; and emotional state. Each question uses an 11-point rating scale, in which the maximum score is 150, denoting excellent recovery. Able to breathe easily Been able to enjoy food Feeling rested Have had a good sleep Able to look after personal toilet and hygiene unaided Able to communicate with family or friends Getting support from hospital doctors and nurses Able to return to work or usual home activities Feeling comfortable and in control Having a feeling of general well-being Moderate pain Severe pain Nausea or vomiting Feeling worried or anxious Feeling sad or depressed

    Secondary Outcome Measures

    NRS score for rest and coughing pain
    Postoperative pain at rest and during coughing was assessed by NRS score with a range of 0 to 10 (0=no pain, 10=the worst possible pain)
    consumption of opioid converted to IV morphine equivalents
    opioids given postoperatively converted to IV morphine equivalents
    the incidence of postoperative hypotension
    Adverse reactions related to opioid
    the incidence of nausea and vomiting
    Adverse reactions related to opioid
    the incidence of pruritus
    Adverse reactions related to opioid
    the incidence of respiratory depression
    Adverse reactions related to opioid
    time to urethral catheter removal in hours
    Time tourethral catheter removal after surgery
    postoperative hospital stay in days
    The time from operation to discharge
    intra-operative opioid requirements
    opioids given intra-operatively
    the block-related outcomes
    the incidence of block-related complications (accidental intravascular injection, local anaesthetic systemic toxicity, haematoma and pneumothorax); and incidence of patient-reported transient neurological complications (paraesthesia or sensory deficit)
    the Brief Pain Inventory
    The Brief Pain Inventory instrument assesses 2 domains: pain and pain-related interference with physical and emotional functioning. pain at its worst in the last 24 hours pain at least in the last 24 hours describe your pain on average how much pain do you have right now interference with general activity interference with working ability interference with work interference with mood interference with relations with other people interference with sleep interference with enjoyment of life

    Full Information

    First Posted
    July 3, 2022
    Last Updated
    July 7, 2022
    Sponsor
    Zhejiang Cancer Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05448638
    Brief Title
    Transversus Thoracic Muscle Plane Combined With Pectoral Nerves Block for Breast Cancer Surgery
    Official Title
    Quality of Recovery Scores in Transversus Thoracic Muscle Plane Combined With Pectoral Nerves Block Versus Pectoral Nerves Block for Breast Cancer Surgery: a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 15, 2022 (Anticipated)
    Primary Completion Date
    July 15, 2023 (Anticipated)
    Study Completion Date
    September 10, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Zhejiang Cancer Hospital

    4. Oversight

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

    5. Study Description

    Brief Summary
    This is a prospective, randomized, controlled trial for evaluating the efficacy of addition of transversus thoracic muscle plane block to pectoral nerves block versus pectoral nerves block for quality of recovery scores in breast cancer surgery.
    Detailed Description
    The pectoral nerves (PECS) block cannot block the most internal mammary region, whereas a transversus thoracic muscle plane (TTP) block can. The combination of PECS and TTP blocks may be suitable for breast cancer surgery. We studied patients undergoing breast cancer surgery to assess whether the combination of PECS and TTP blocks provides better postoperative recovery than PECS block alone.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    116 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    transversus thoracic muscle plane block+pectoral nerves block
    Arm Type
    Experimental
    Arm Description
    the combination of transversus thoracic muscle plane and pectoral nerves blocks
    Arm Title
    pectoral nerves block
    Arm Type
    Active Comparator
    Arm Description
    the pectoral nerves block only
    Intervention Type
    Procedure
    Intervention Name(s)
    the combination of transversus thoracic muscle plane and pectoral nerves blocks
    Intervention Description
    For the pectoral nerves block, 0.375% ropivacaine , 10ml was injected between the pectoralis major and pectoralis minor and 20 ml above the serratus anterior muscle. For the transversus thoracic muscle plane block, ropivacaine 0.375%,15ml was injected between the transversus thoracic muscle and the internal intercostal muscle.
    Intervention Type
    Procedure
    Intervention Name(s)
    the pectoral nerves block only
    Intervention Description
    For the pectoral nerves block, 0.375% ropivacaine , 10ml was injected between the pectoralis major and pectoralis minor and 20 ml above the serratus anterior muscle.
    Primary Outcome Measure Information:
    Title
    the quality of recovery-15 questionnaire (QoR-15)
    Description
    The QoR-15 is a validated short-form postoperative quality of recovery score. Fifteen questions assess five domains of patient health-related quality of life: pain; comfort; physical independence; psychological support; and emotional state. Each question uses an 11-point rating scale, in which the maximum score is 150, denoting excellent recovery. Able to breathe easily Been able to enjoy food Feeling rested Have had a good sleep Able to look after personal toilet and hygiene unaided Able to communicate with family or friends Getting support from hospital doctors and nurses Able to return to work or usual home activities Feeling comfortable and in control Having a feeling of general well-being Moderate pain Severe pain Nausea or vomiting Feeling worried or anxious Feeling sad or depressed
    Time Frame
    at 24 hours after surgery
    Secondary Outcome Measure Information:
    Title
    NRS score for rest and coughing pain
    Description
    Postoperative pain at rest and during coughing was assessed by NRS score with a range of 0 to 10 (0=no pain, 10=the worst possible pain)
    Time Frame
    at 1, 6, 24, 48 hours after surgery
    Title
    consumption of opioid converted to IV morphine equivalents
    Description
    opioids given postoperatively converted to IV morphine equivalents
    Time Frame
    during 24 hours after surgery
    Title
    the incidence of postoperative hypotension
    Description
    Adverse reactions related to opioid
    Time Frame
    during 48 hours after surgery
    Title
    the incidence of nausea and vomiting
    Description
    Adverse reactions related to opioid
    Time Frame
    during 48 hours after surgery
    Title
    the incidence of pruritus
    Description
    Adverse reactions related to opioid
    Time Frame
    during 48 hours after surgery
    Title
    the incidence of respiratory depression
    Description
    Adverse reactions related to opioid
    Time Frame
    during 48 hours after surgery
    Title
    time to urethral catheter removal in hours
    Description
    Time tourethral catheter removal after surgery
    Time Frame
    through study completion, an average of 24-36 hours
    Title
    postoperative hospital stay in days
    Description
    The time from operation to discharge
    Time Frame
    through study completion, an average of 5-7 days
    Title
    intra-operative opioid requirements
    Description
    opioids given intra-operatively
    Time Frame
    through the anesthesia process, an average of 1.5-2.5h
    Title
    the block-related outcomes
    Description
    the incidence of block-related complications (accidental intravascular injection, local anaesthetic systemic toxicity, haematoma and pneumothorax); and incidence of patient-reported transient neurological complications (paraesthesia or sensory deficit)
    Time Frame
    through study completion, an average of 5-7 days
    Title
    the Brief Pain Inventory
    Description
    The Brief Pain Inventory instrument assesses 2 domains: pain and pain-related interference with physical and emotional functioning. pain at its worst in the last 24 hours pain at least in the last 24 hours describe your pain on average how much pain do you have right now interference with general activity interference with working ability interference with work interference with mood interference with relations with other people interference with sleep interference with enjoyment of life
    Time Frame
    at 3 months after surgery.

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: female, 18-80 years of age American Society of Anesthesiologists physical status I-III patients having elective unilateral breast cancer surgery Exclusion Criteria: contraindication to nerve block inability to understand or communicate with research personnel chronic use of opioids or nonsteroidal anti-inflammatory drugs pregnancy
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ji Zhu, MD, PHD
    Phone
    0086057188122564
    Email
    ec@zjcc.org.cn
    First Name & Middle Initial & Last Name or Official Title & Degree
    Lihong Wang, MD
    Phone
    008613575725157
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Huifang Jiang, MD
    Organizational Affiliation
    Zhejiang Cancer Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Yes: There is a plan to make IPD and related data dictionaries available.
    IPD Sharing Time Frame
    starting about 6 months after publication
    IPD Sharing Access Criteria
    We will share data on ClinicalTrials.gov, and data sharing will be always available.

    Learn more about this trial

    Transversus Thoracic Muscle Plane Combined With Pectoral Nerves Block for Breast Cancer Surgery

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