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

Breast Cancer Clinical Trial

Official title:

Ultrasound-guided Subpectoral Plexus Block With Multi-level Thoracic Paravertebral Block for Surgical Anaesthesia During Primary Breast Cancer Surgery: A Prospective Randomized Double-blind Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04933266
• Other study ID #: mTPVB SPPB Ver 2
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: March 31, 2025

Study information

• Verified date: April 2024
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• Subpectoral plexus block (low dose)
It is one type of peripheral nerve blocks for surgery over the chest. Patients will have an ultrasound scan and nerve block with local anesthetic (LA) agent (0.25% levobupivacaine 10ml) injected 2 target sites through one skin puncture. One at the myofascial plane between the pectoralis major and minor (5ml of LA) and then under direct ultrasound visualization, the needle will be redirected and the remaining 5ml of LA will be injected at the plane between the pectoralis minor and the serratus anterior muscle, close to the origin of thoracoacromial artery from the axillary artery at the level of the third rib.
• Subpectoral plexus block (High dose)
It is one type of peripheral nerve blocks for surgery over the chest. Patients will have an ultrasound scan and nerve block with local anesthetic (LA) agent (0.25% levobupivacaine 20ml) injected 2 target sites through one skin puncture. One at the myofascial plane between the pectoralis major and minor (10ml of LA) and then under direct ultrasound visualization, the needle will be redirected and the remaining 10ml of LA will be injected at the plane between the pectoralis minor and the serratus anterior muscle, close to the origin of thoracoacromial artery from the axillary artery at the level of the third rib.

Locations

Country	Name	City	State
Hong Kong	North District Hospital	Sheung Shui	New Territories

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients requiring intraoperative ketamine	The total number of patients (in percentage) requiring intraoperative ketamine bolus during the surgery	during surgery
Secondary	Total amount of rescue ketamine used	The total amount of rescue ketamine (mg) required during surgery	during surgery
Secondary	Specific surgical region requiring rescue ketamine	The exact surgical region(s), such as infraclavicular, parasternal, axillary, subcostal) that rescue ketamine has to be given during surgery	during surgery
Secondary	Pain score on admission at Post Anaesthetic Care Unit (PACU)	Pain score (Numeric rating scale 0-100; 0=no pain, 100=severe pain) on admission at PACU	Assessed once on admission at Post Anaesthetic Care Unit immediately after surgery
Secondary	Pain score at Discharge of Post Anaesthetic Care Unit (PACU)	Pain Score (Numeric rating scale 0-100; 0=no pain, 100=severe pain) at discharge from PACU	immediately before discharge from PACU