Revised-Paravertebral Nerve Blocks for Enhanced Recovery After Video-assisted Thoracoscopic Pneumonectomy (r-PVB-1)
Revised-Paravertebral Nerve Blocks for Video-Assisted Thoracoscopic Surgery: A Randomized, Controlled, Observer-masked Noninferiority Trial.
Aperçu de l'étude
Statut
Statut
Les conditions
Les conditions
Intervention / Traitement
Intervention / Traitement
Type d'étude
Type d'étude
Inscription (Estimé)
Inscription
Phase
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
Coordonnées de l'étude
- Nom: Xiangcai Ruan, MD
- Numéro de téléphone: +86 13760710099
- E-mail: ruanxc@mail.sysu.edu.cn
Critères de participation
Critère d'éligibilité
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Age 18 years or older
- Scheduled for elective video-assisted thoracoscopic pneumonectomy for benign or malignant diseases
Exclusion Criteria:
- Contraindications to nerve block, including skin infection at the puncture site, increased intracranial pressure, uncorrectable coagulopathy, bridging indication for therapeutic anticoagulation (CHADS-VASc ≥ 8), sepsis, or allergy to local anesthetics
- Surgeon-estimated high likelihood of conversion to open surgery
- Chronic opioid use
- Heart failure, liver failure, or renal failure
- Coagulation disorders
- History of allergy to local anesthetics
- Inability to comply with the study protocol, including severe psychiatric illness, refusal to provide informed consent, or anticipated difficulty with postoperative follow-up
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Nombre de bras
Armes et Interventions
Groupe de participants / BrasGroupe de participants / Bras |
Intervention / TraitementIntervention / Traitement |
|---|---|
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Expérimental: r-PVB
Participants in this arm will receive Revised-Paravertebral Nerve Block (r-PVB) after induction of general anesthesia and before the start of surgery.
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Revised-Paravertebral Nerve Block (r-PVB) is performed after induction of general anesthesia and before the start of surgery.
Under ultrasound guidance, an intercostal space between the 7th and 9th ribs at the midaxillary line is identified.
Using an in-plane technique, the needle is advanced into the internal intercostal muscle, and 30 mL of 0.5% ropivacaine is injected to achieve the block.
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Autre: PVB
Control
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Paravertebral Nerve Block (PVB), the control of investigated intervention, is performed right after the lateral positioning of surgery under ultrasound guidance.
According to the operator's preference, choose any of the commonly used three traditional paravertebral block approaches.
Among these 3 approaches, the axial plane approach is recommended as the first choice: use the convex probe to identify the transverse process, then scan cranially to display the superior costotransverse ligament, pleura, and paravertebral space.
Under sterile conditions, insert the needle in-plane approximately 2 cm lateral to the probe, ensuring the ultrasound probe remains stable and dynamically visualizing the needle advancement.
Stop advancing the needle when the tip passes through the superior costotransverse ligament.
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Que mesure l'étude ?
Principaux critères de jugement
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Mean postoperative NRS pain score during the first 2 postoperative days
Délai: From post-anesthesia care unit through postoperative day 2
|
Postoperative pain will be assessed using a Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst pain the patient can imagine).
The primary pain outcome is the mean of 8 postoperative NRS pain scores collected in the post-anesthesia care unit, on the evening of surgery, and on postoperative days 1 and 2 (morning, midday, and evening).
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From post-anesthesia care unit through postoperative day 2
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Mean QoR-15 score on postoperative days 1 and 2
Délai: Postoperative day 1 and postoperative day 2
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Quality of recovery will be assessed using the 15-item Quality of Recovery questionnaire (QoR-15), ranging from 0 (the worst) to 150 (the best).
The primary recovery outcome is the mean QoR-15 score measured on postoperative day 1 and postoperative day 2.
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Postoperative day 1 and postoperative day 2
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Mesures de résultats secondaires
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Postoperative opioid and analgesic consumption
Délai: Postoperative day 1 and postoperative day 2
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Postoperative opioid and other analgesic consumption will be recorded and compared between groups.
Opioid use will be converted to oral morphine equivalents where appropriate.
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Postoperative day 1 and postoperative day 2
|
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Postoperative complications
Délai: From surgery through postoperative day 30
|
Postoperative complications, including pneumothorax, nausea, vomiting, dizziness, respiratory depression, and other adverse events, will be recorded and compared between groups.
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From surgery through postoperative day 30
|
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Length of postoperative hospital stay
Délai: From surgery through postoperative day 30
|
Length of hospital stay will be defined as the total number of days hospitalized after surgery, including readmission within 30 days if applicable.
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From surgery through postoperative day 30
|
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Patient satisfaction with analgesia
Délai: Postoperative day 2
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Patient satisfaction with postoperative analgesia will be assessed using a 5-point scale ranging from very dissatisfied to very satisfied.
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Postoperative day 2
|
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Resting and movement NRS pain scores on postoperative days 1 and 2
Délai: Postoperative day 1 and postoperative day 2
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Resting and movement-related pain will be assessed using the Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst pain the patient can imagine), at predefined time points on postoperative days 1 and 2.
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Postoperative day 1 and postoperative day 2
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Proportion of participants with pain score 4 or greater
Délai: Postoperative day 1 and postoperative day 2
|
The proportion of participants with clinically significant pain, defined as the Numerical Rating Scale (NRS, 0-10) of 4 or greater, will be compared between groups.
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Postoperative day 1 and postoperative day 2
|
Autres mesures de résultats
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Incidence of local anesthetic systemic toxicity
Délai: From intervention through postoperative day 30
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The incidence of local anesthetic systemic toxicity (LAST) will be recorded and compared between groups.
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From intervention through postoperative day 30
|
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Morbidity within 30 days after surgery
Délai: From surgery through postoperative day 30
|
Postoperative morbidity within 30 days after surgery will be recorded and compared between groups.
|
From surgery through postoperative day 30
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Readmission within 30 days after surgery
Délai: From surgery through postoperative day 30
|
Hospital readmission within 30 days after surgery will be recorded and compared between groups.
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From surgery through postoperative day 30
|
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Pain scores at 30 days after surgery
Délai: Postoperative day 30
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Resting and movement-related pain at 30 days after surgery will be assessed using the Numerical Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst pain the patient can imagine).
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Postoperative day 30
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QoR-15 score at 30 days after surgery
Délai: Postoperative day 30
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Quality of recovery at 30 days after surgery will be assessed using the 15-item Quality of Recovery questionnaire (QoR-15), ranging from 0 (the worst) to 150 (the best).
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Postoperative day 30
|
Collaborateurs et enquêteurs
Parrainer
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Début de l'étude
Achèvement primaire (Estimé)
Achèvement primaire
Achèvement de l'étude (Estimé)
Achèvement de l'étude
Dates d'inscription aux études
Première soumission
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Première publication
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour publiée
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
Autres numéros d'identification d'étude
- E2026081
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Informations sur les médicaments et les dispositifs, documents d'étude
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