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

NCT05448638 | Completed

• 1 other identifier: IRB-2022-348
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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. 1. Able to breathe easily 2. Been able to enjoy food 3. Feeling rested 4. Have had a good sleep 5. Able to look after personal toilet and hygiene unaided 6. Able to communicate with family or friends 7. Getting support from hospital doctors and nurses 8. Able to return to work or usual home activities 9. Feeling comfortable and in control 10. Having a feeling of general well-being 11. Moderate pain 12. Severe pain 13. Nausea or vomiting 14. Feeling worried or anxious 15. Feeling sad or depressed

  at 24 hours after surgery

Secondary Outcomes (11)

• NRS score for rest and coughing pain

  at 1, 6, 24, 48 hours after surgery

• consumption of opioid converted to IV morphine equivalents

  during 24 hours after surgery

• the incidence of postoperative hypotension

  during 48 hours after surgery

• the incidence of nausea and vomiting

  during 48 hours after surgery

• the incidence of pruritus

  during 48 hours after surgery

Study Arms (2)

transversus thoracic muscle plane block+pectoral nerves block

EXPERIMENTAL

the combination of transversus thoracic muscle plane and pectoral nerves blocks

Procedure: the combination of transversus thoracic muscle plane and pectoral nerves blocks

pectoral nerves block

ACTIVE COMPARATOR

the pectoral nerves block only

Procedure: the pectoral nerves block only

Interventions

the combination of transversus thoracic muscle plane and pectoral nerves blocks PROCEDURE

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.

transversus thoracic muscle plane block+pectoral nerves block

the pectoral nerves block only PROCEDURE

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.

pectoral nerves block

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Location

Related Publications (1)

• Gu B, Huang ZX, Zhou HD, Lian YH, He S, Ge M, Jiang HF. A Randomized Controlled Trial of Adding Deep Parasternal Intercostal Plane Block to Interpectoral-Pectoserratus Plane Block in Breast Cancer Surgery. Anesth Analg. 2025 May 1;140(5):1188-1194. doi: 10.1213/ANE.0000000000007218.

  PMID: 39453840 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Huifang Jiang, MD

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 3, 2022
• First Posted: July 7, 2022
• Study Start: July 12, 2022
• Primary Completion: May 5, 2023
• Study Completion: August 5, 2023
• Last Updated: November 21, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: starting about 6 months after publication
• Access Criteria: We will share data on ClinicalTrials.gov, and data sharing will be always available.

Locations

CN (1)