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

NCT04933266 | Recruiting

• 1 other identifier: 2021.248-T mTPVB SPPB Ver 2
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Subpectoral plexus block; Thoracic paravertebral block; Primary breast cancer surgery

Outcome Measures

Primary Outcomes (1)

• Proportion of patients requiring intraoperative ketamine

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

  during surgery

Secondary Outcomes (4)

• Total amount of rescue ketamine used

  during surgery

• Specific surgical region requiring rescue ketamine

  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 at Discharge of Post Anaesthetic Care Unit (PACU)

  immediately before discharge from PACU

Study Arms (2)

Low dose

ACTIVE COMPARATOR

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).

Procedure: Subpectoral plexus block (low dose)

High dose

ACTIVE COMPARATOR

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).

Procedure: Subpectoral plexus block (High dose)

Interventions

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.

Also known as: Drug (0.25% Chirocaine)

Low dose

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.

Also known as: Drug (0.25% Chirocaine)

High dose

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

North District Hospital

Sheung Shui, New Territories, Hong Kong

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Pharmaceutical Preparations; Levobupivacaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Manoj K Karmakar, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayla Wong, RN, BN

CONTACT

3505 6157; aylawong@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients in both study groups will not be able to know the dosage they will receive during the block and therefore will be blinded to group allocation. The "outcome assessor" (research nurse) will not be presented in the procedure room during block placement and thus will also be blinded to group allocation. The anesthesiologist (principal investigator) performing the allocated block will take no further part in the study after block placement.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Patients will be randomly assigned to received either 10ml of 0.25% levobupivacaine (Group LD) or 20ml of 0.25% levobupivacaine (Group HD). The randomization sequence will be generated using an online randomization software (www.randomization.com). The randomization sequence will be assigned as 1=low dose 10ml (Group LD) and 2=high dose 20ml (Group HD). The group allocation will be prepared by a computer officer (third party) in the Department of Anaesthesia \& Intensive Care of the Chinese University of Hong Kong.

Study Record Dates

• First Submitted: June 17, 2021
• First Posted: June 21, 2021
• Study Start: March 15, 2024
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: April 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)