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Clinical Trials/NCT04933266
NCT04933266
Recruiting
Not Applicable

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

Chinese University of Hong Kong1 site in 1 country100 target enrollmentMarch 15, 2024
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Chinese University of Hong Kong
Enrollment
100
Locations
1
Primary Endpoint
Proportion of patients requiring intraoperative ketamine
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 15, 2024
End Date
March 31, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Prof Manoj K Karmakar

Professor

Chinese University of Hong Kong

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • Total amount of rescue ketamine used(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)
  • Specific surgical region requiring rescue ketamine(during surgery)

Study Sites (1)

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