Subpectoral Plexus Block With Multi-level TPVB for Surgical Anesthesia During Primary Breast Cancer Surgery

Not Applicable

Recruiting

• Conditions: Breast Cancer
• Interventions: Procedure: Subpectoral plexus block (low dose); Procedure: Subpectoral plexus block (High dose)

• Registration Number: NCT04933266
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

The objective of this study is to compare two different doses of local anesthetics (10ml vs 20ml of 0.25% levobupivacaine) for subpectoral plexus block (SPPB) in addition to ultrasound guided multi-level of thoracic paravertebral block (m-TPVB) for surgical anaesthesia for major primary breast cancer surgery.

Detailed Description

Primary breast cancer surgery is one of the most commonly performed surgeries worldwide. It is associated with significant acute postoperative pain and a high incidence of chronic postsurgical pain. Regional anaesthetic techniques are shown to improve outcomes such as postoperative analgesia, nausea, vomiting, delirium and promote early recovery. Currently majority of the breast cancer surgery is performed under general anaesthesia with a multimodal analgesic regimen with or without regional blocks. In fact, it is proved that breast cancer surgery can be done solely under regional anesthesia using multilevel thoracic paravertebral block (TPVB) with deep sedation, but rescue analgesia are often required intraoperatively, especially when surgeons handles the pectoralis muscle. Current evidence suggest that pectoral nerves, which are often described as a pure motor nerves that control movements only, also able to send noxious stimulation such as pain from the pectoral muscles and its deep fascia (via afferent nociceptive fibers) to the brain. Principal investigator proposes that adding a subpectoral plexus block (SPPB) will stop a wider spectrum of afferent nociceptive fibers from sending any pain signals than having thoracic paravertebral block alone. However, there is no report on the amount of local anaesthetic (LA) required to achieve surgical anaesthesia for breast surgery. The aim of this study is to evaluate the effectiveness of two different doses (10ml vs 20ml of 0.25% levobupivacaine) of local anaesthetic (LA) for subpectoral plexus in addition to 3 levels of TPVB injections at T2, T4, and T6 under ultrasound guidance for surgical anaesthesia for major breast cancer surgery.

Study Timeline

• Study First Submitted: 2021-06-17
• Study First Submitted QC: 2021-06-18
• Study First Posted: 2021-06-21
• Study Start: 2024-03-15
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-11
• Primary Completion: 2026-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• scheduled for mastectomy, modified radical mastectomy or breast conservative surgery with lymph node biopsy and with or without axillary dissection

Exclusion Criteria

• local skin site infection
• coagulopathy
• history of allergy to local anesthetics

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low dose	Subpectoral plexus block (low dose)	After three injections of thoracic paravertebral block at T2, T4, T6 (a total of 21ml of 0.5% levobupivacaine with 1:200,000 adrenaline) under ultrasound guidance, patients will be put in supine position with ipsilateral arm and elbow flexed. Ultrasound scan will be performed below collarbone region, 5ml of 0.25% levobupivacaine will be injected in the first plane between pectoralis major and minor. Then under direct ultrasound visualization, the remaining 5ml of 0.25% levobupivacaine will be injected between the second plane of pectoralis minor and serratus anterior muscle (a total of 10ml will be given).
High dose	Subpectoral plexus block (High dose)	After three injections of thoracic paravertebral block at T2, T4, T6 (a total of 21ml of 0.5% levobupivacaine with 1:200,000 adrenaline) under ultrasound guidance, patients will be put in supine position with ipsilateral arm and elbow flexed. Ultrasound scan will be performed below collarbone region, 10ml of 0.25% levobupivacaine will be injected in the first plane between pectoralis major and minor. Then under direct ultrasound visualization, the remaining 10ml of 0.25% levobupivacaine will be injected between the second plane of pectoralis minor and serratus anterior muscle (a total of 20ml will be given).

Primary Outcome Measures

Name	Time	Method
Proportion of patients requiring intraoperative ketamine	during surgery	The total number of patients (in percentage) requiring intraoperative ketamine bolus during the surgery

Secondary Outcome Measures

Name	Time	Method
Total amount of rescue ketamine used	during surgery	The total amount of rescue ketamine (mg) required during surgery
Pain score on admission at Post Anaesthetic Care Unit (PACU)	Assessed once on admission at Post Anaesthetic Care Unit immediately after surgery	Pain score (Numeric rating scale 0-100; 0=no pain, 100=severe pain) on admission at PACU
Pain score at Discharge of Post Anaesthetic Care Unit (PACU)	immediately before discharge from PACU	Pain Score (Numeric rating scale 0-100; 0=no pain, 100=severe pain) at discharge from PACU
Specific surgical region requiring rescue ketamine	during surgery	The exact surgical region(s), such as infraclavicular, parasternal, axillary, subcostal) that rescue ketamine has to be given during surgery

Trial Locations

Locations (1)

North District Hospital; 🇭🇰 Sheung Shui, New Territories, Hong Kong