Bloc de plexus sous-pectoral avec TPVB à plusieurs niveaux pour l'anesthésie chirurgicale pendant la chirurgie primaire du cancer du sein
Bloc du plexus sous-pectoral guidé par ultrasons avec bloc paravertébral thoracique à plusieurs niveaux pour l'anesthésie chirurgicale pendant la chirurgie primaire du cancer du sein : un essai prospectif randomisé en double aveugle
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
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New Territories
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Sheung Shui, New Territories, Hong Kong
- North District Hospital
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: 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.
Autres noms:
|
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Comparateur actif: 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.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Proportion of patients requiring intraoperative ketamine
Délai: during surgery
|
The total number of patients (in percentage) requiring intraoperative ketamine bolus during the surgery |
during surgery
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Total amount of rescue ketamine used
Délai: during surgery
|
The total amount of rescue ketamine (mg) required during surgery |
during surgery
|
|
Specific surgical region requiring rescue ketamine
Délai: during surgery
|
The exact surgical region(s), such as infraclavicular, parasternal, axillary, subcostal) that rescue ketamine has to be given during surgery |
during surgery
|
|
Pain score on admission at Post Anaesthetic Care Unit (PACU)
Délai: 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 |
Assessed once on admission at Post Anaesthetic Care Unit immediately after surgery
|
|
Pain score at Discharge of Post Anaesthetic Care Unit (PACU)
Délai: immediately before discharge from PACU
|
Pain Score (Numeric rating scale 0-100; 0=no pain, 100=severe pain) at discharge from PACU |
immediately before discharge from PACU
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Manoj K Karmakar, MD, Chinese University of Hong Kong
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2021.248-T mTPVB SPPB Ver 2
Informations sur les médicaments et les dispositifs, documents d'étude
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