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

Primary Purpose

Breast Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Subpectoral plexus block (low dose)
Subpectoral plexus block (High dose)
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Subpectoral plexus block, Thoracic paravertebral block, Primary breast cancer surgery

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • North District Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Low dose

High dose

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 17, 2021
Last Updated
August 8, 2023
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT04933266
Brief Title
Subpectoral Plexus Block With Multi-level TPVB for Surgical Anesthesia During Primary Breast Cancer Surgery
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
October 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Subpectoral plexus block, Thoracic paravertebral block, Primary breast cancer surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low dose
Arm Type
Active Comparator
Arm Description
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).
Arm Title
High dose
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
Subpectoral plexus block (low dose)
Other Intervention Name(s)
Drug (0.25% Chirocaine)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Subpectoral plexus block (High dose)
Other Intervention Name(s)
Drug (0.25% Chirocaine)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of patients requiring intraoperative ketamine
Description
The total number of patients (in percentage) requiring intraoperative ketamine bolus during the surgery
Time Frame
during surgery
Secondary Outcome Measure Information:
Title
Total amount of rescue ketamine used
Description
The total amount of rescue ketamine (mg) required during surgery
Time Frame
during surgery
Title
Specific surgical region requiring rescue ketamine
Description
The exact surgical region(s), such as infraclavicular, parasternal, axillary, subcostal) that rescue ketamine has to be given during surgery
Time Frame
during surgery
Title
Pain score on admission at Post Anaesthetic Care Unit (PACU)
Description
Pain score (Numeric rating scale 0-100; 0=no pain, 100=severe pain) on admission at PACU
Time Frame
Assessed once on admission at Post Anaesthetic Care Unit immediately after surgery
Title
Pain score at Discharge of Post Anaesthetic Care Unit (PACU)
Description
Pain Score (Numeric rating scale 0-100; 0=no pain, 100=severe pain) at discharge from PACU
Time Frame
immediately before discharge from PACU

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cheuk Man Cheung, RN, BN, MSc
Phone
3505 2734
Email
cheukmancheung@cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manoj K Karmakar, MD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
North District Hospital
City
Sheung Shui
State/Province
New Territories
Country
Hong Kong
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cheuk Man Cheung, RN, BN, MSc
Phone
+852 55696157
Email
cheukmancheung@cuhk.edu.hk
First Name & Middle Initial & Last Name & Degree
Manoj K Karmakar, MD

12. IPD Sharing Statement

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

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