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出境医 / 临床实验 / Subpectoral Plexus Block With Multi-level TPVB for Surgical Anesthesia During Primary Breast Cancer Surgery

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

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: Subpectoral plexus block (low dose) Procedure: Subpectoral plexus block (High dose) Not Applicable

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.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Double (Participant, Outcomes 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.
Primary Purpose: Treatment
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
Actual Study Start Date : August 6, 2021
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : September 2022
Arms and Interventions
Arm Intervention/treatment
Active Comparator: Low dose
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)
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 Name: Drug (0.25% Chirocaine)
Active Comparator: High dose
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)
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 Name: Drug (0.25% Chirocaine)
Outcome Measures
Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Winnie Samy, RN, BN, MSc 3505 2734 wsamy@cuhk.edu.hk

Locations
Layout table for location information
Hong Kong
North District Hospital Recruiting
Sheung Shui, New Territories, Hong Kong
Contact: Winnie Samy, RN, BN, MSc    +85226838092    wsamy@cuhk.edu.hk   
Principal Investigator: Manoj K Karmakar, MD         
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Layout table for investigator information
Principal Investigator: Manoj K Karmakar, MD Chinese University of Hong Kong
Tracking Information
First Submitted Date  ICMJE June 17, 2021
First Posted Date  ICMJE June 21, 2021
Last Update Posted Date September 1, 2021
Actual Study Start Date  ICMJE August 6, 2021
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2021) 		Proportion of patients requiring intraoperative ketamine [ Time Frame: during surgery ]
The total number of patients (in percentage) requiring intraoperative ketamine bolus during the surgery
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2021)
  • Total amount of rescue ketamine used [ Time Frame: during surgery ]
    The total amount of rescue ketamine (mg) required during surgery
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Subpectoral Plexus Block With Multi-level TPVB for Surgical Anesthesia During Primary Breast Cancer Surgery
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Double (Participant, Outcomes 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.
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • 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.
    Other Name: Drug (0.25% Chirocaine)
  • Procedure: 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.
    Other Name: Drug (0.25% Chirocaine)
Study Arms  ICMJE
  • Active Comparator: Low dose
    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).
    Intervention: Procedure: Subpectoral plexus block (low dose)
  • Active Comparator: High dose
    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: Procedure: Subpectoral plexus block (High dose)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 18, 2021) 		100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2022
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Winnie Samy, RN, BN, MSc 3505 2734 wsamy@cuhk.edu.hk
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04933266
Other Study ID Numbers  ICMJE mTPVB SPPB Ver 2
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof Manoj K Karmakar, Chinese University of Hong Kong
Study Sponsor  ICMJE Chinese University of Hong Kong
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Manoj K Karmakar, MD Chinese University of Hong Kong
PRS Account Chinese University of Hong Kong
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP