Subpektorale Plexusblockade mit mehrstufigem TPVB für die chirurgische Anästhesie während der primären Brustkrebsoperation
Ultraschallgeführte subpektorale Plexusblockade mit mehrstufiger thorakaler paravertebraler Blockade zur chirurgischen Anästhesie während der primären Brustkrebsoperation: Eine prospektive randomisierte Doppelblindstudie
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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New Territories
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Sheung Shui, New Territories, Hongkong
- North District Hospital
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-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Aktiver Komparator: 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). |
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.
Andere Namen:
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Aktiver Komparator: 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). |
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.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Proportion of patients requiring intraoperative ketamine
Zeitfenster: during surgery
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The total number of patients (in percentage) requiring intraoperative ketamine bolus during the surgery |
during surgery
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Total amount of rescue ketamine used
Zeitfenster: during surgery
|
The total amount of rescue ketamine (mg) required during surgery |
during surgery
|
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Specific surgical region requiring rescue ketamine
Zeitfenster: during surgery
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The exact surgical region(s), such as infraclavicular, parasternal, axillary, subcostal) that rescue ketamine has to be given during surgery |
during surgery
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Pain score on admission at Post Anaesthetic Care Unit (PACU)
Zeitfenster: Assessed once on admission at Post Anaesthetic Care Unit immediately after surgery
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Pain score (Numeric rating scale 0-100; 0=no pain, 100=severe pain) on admission at PACU |
Assessed once on admission at Post Anaesthetic Care Unit immediately after surgery
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Pain score at Discharge of Post Anaesthetic Care Unit (PACU)
Zeitfenster: immediately before discharge from PACU
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Pain Score (Numeric rating scale 0-100; 0=no pain, 100=severe pain) at discharge from PACU |
immediately before discharge from PACU
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Manoj K Karmakar, MD, Chinese University of Hong Kong
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2021.248-T mTPVB SPPB Ver 2
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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