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

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: the combination of transversus thoracic muscle plane and pectoral nerves blocks; Procedure: the pectoral nerves block only

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.

• Study Type: Interventional
• Enrollment (Actual): 116
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Zhejiang Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: transversus thoracic muscle plane block+pectoral nerves block; the combination of transversus thoracic muscle plane and pectoral nerves blocks	Procedure: the combination of transversus thoracic muscle plane and pectoral nerves blocks; 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.
Active Comparator: pectoral nerves block; the pectoral nerves block only	Procedure: the pectoral nerves block only; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	at 24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
consumption of opioid converted to IV morphine equivalents	opioids given postoperatively converted to IV morphine equivalents	during 24 hours after surgery
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)	at 1, 6, 24, 48 hours after surgery
the incidence of postoperative hypotension	Adverse reactions related to opioid	during 48 hours after surgery
the incidence of nausea and vomiting	Adverse reactions related to opioid	during 48 hours after surgery
the incidence of pruritus	Adverse reactions related to opioid	during 48 hours after surgery
the incidence of respiratory depression	Adverse reactions related to opioid	during 48 hours after surgery
time to urethral catheter removal in hours	Time tourethral catheter removal after surgery	through study completion, an average of 24-36 hours
postoperative hospital stay in days	The time from operation to discharge	through study completion, an average of 5-7 days
intra-operative opioid requirements	opioids given intra-operatively	through the anesthesia process, an average of 1.5-2.5h
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)	through study completion, an average of 5-7 days
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	at 3 months after surgery.

Collaborators and Investigators

• Sponsor: Zhejiang Cancer Hospital
• Investigators: Principal Investigator: Huifang Jiang, MD, Zhejiang Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2022
• Primary Completion (Actual): May 5, 2023
• Study Completion (Actual): August 5, 2023

Study Registration Dates

• First Submitted: July 3, 2022
• First Submitted That Met QC Criteria: July 3, 2022
• First Posted (Actual): July 7, 2022

Study Record Updates

• Last Update Posted (Estimated): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 17, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: IRB-2022-348

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No