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
About this trial
This is an interventional treatment trial for Breast Cancer
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
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
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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