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NCT Number: NCT04933266

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

North District Hospital

Sheung Shui, New Territories, Hong Kong

Location status: Recruiting

Location contact

Hoi Ling Wong, RN, BN, MSc

CONTACT

[email protected]

+852 55696157

Manoj K Karmakar, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Subpectoral plexus block (low dose)

Procedure

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.

Other names: Drug (0.25% Chirocaine)

Subpectoral plexus block (High dose)

Procedure

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.

Other names: Drug (0.25% Chirocaine)

Primary outcomes

  1. Proportion of patients requiring intraoperative ketamine

    Time frame: during surgery

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

Secondary outcomes

  1. Total amount of rescue ketamine used

    Time frame: during surgery

    The total amount of rescue ketamine (mg) required during surgery

  2. Specific surgical region requiring rescue ketamine

    Time frame: during surgery

    The exact surgical region(s), such as infraclavicular, parasternal, axillary, subcostal) that rescue ketamine has to be given during surgery

  3. Pain score on admission at Post Anaesthetic Care Unit (PACU)

    Time frame: 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

  4. Pain score at Discharge of Post Anaesthetic Care Unit (PACU)

    Time frame: immediately before discharge from PACU

    Pain Score (Numeric rating scale 0-100; 0=no pain, 100=severe pain) at discharge from PACU

Study contacts

Contact information is provided by the study sponsor or research team.

Ayla Wong, RN, BN

CONTACT

[email protected]

3505 6157

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 21, 2021
Registry last updated
Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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