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- Essai clinique NCT07642336
Erector Spinae Plane Block Versus Thoracic Epidural Analgesia for Open Liver Resection
17 août 2026 mis à jour par: Nguyen Toan Thang
Comparison of Postoperative Analgesic Efficacy Between Erector Spinae Plane Block and Thoracic Epidural Analgesia in Open Hepatectomy: A Randomized Controlled Trial
Background: Open liver resection is associated with severe postoperative pain.
While thoracic epidural analgesia (TEA) is considered the gold standard for pain control, its clinical application is often limited by postoperative coagulation profile derangement, which increases the risk of epidural hematoma.
Continuous erector spinae plane block (ESPB) has emerged as a promising, safer alternative with a lower risk of bleeding complications.
Objective: This study aims to compare the postoperative analgesic efficacy, safety profiles, and impacts on respiratory function between ultrasound-guided continuous ESPB and TEA in patients undergoing elective open liver resection.
Hypothesis: The investigators hypothesize that continuous ESPB using a programmed intermittent bolus (PIB) regimen is non-inferior to TEA regarding 72-hour postoperative pain scores at rest, while offering superior hemodynamic stability and fewer technique-related risks.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
This is a randomized, controlled, parallel-group, non-inferiority clinical trial conducted at Bach Mai Hospital.
Eligible patients scheduled for elective open liver resection will be randomly allocated into one of two groups at a 1:1 ratio: 1. ESPB Group (n = 30): Patients will receive bilateral erector spinae plane catheters placed at the T7 level under ultrasound guidance prior to anesthesia induction.
A bolus of 20 mL Ropivacaine 0.2% will be administered on each side.
Postoperative analgesia will be maintained for 72 hours using a Programmed Intermittent Bolus (PIB) regimen of Ropivacaine 0.1%: 20 mL every 3 hours on the right side and 20 mL every 3 hours on the left side.
2. TEA Group (n = 30): Patients will receive a thoracic epidural catheter inserted at the T7-T8 interspace.
An initial bolus of 10 mL Ropivacaine 0.2% will be given, followed by a continuous basal infusion of Ropivacaine 0.1% at 5-8 mL/h for 72 hours.
Multimodal Analgesia: All patients in both groups will receive a standardized general anesthesia protocol and systemic multimodal analgesia, including intravenous paracetamol (1 g every 6 hours) and nefopam (20 mg every 6 hours).
Outcomes Evaluation: The primary outcome is the postoperative pain intensity measured by the Numerical Rating Scale (NRS) at rest 24 hours after surgery.
Secondary outcomes include NRS pain scores at rest and during coughing at multiple time points up to 72 hours, cumulative 24-hour morphine consumption, hemodynamic parameters, and incidence of adverse events (e.g., hypotension, postoperative nausea and vomiting, hematoma, or catheter failure)
Type d'étude
Interventionnel
Inscription (Réel)
63
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Kim Lien
-
Hà Nội, Kim Lien, Viêt Nam
- Department of Anesthesiology and Resuscitation, Bach Mai Hospital
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
Inclusion Criteria:
* Patients aged between 18 and 80 years old.
- American Society of Anesthesiologists (ASA) physical status classification I to III.
- Scheduled to undergo elective open liver resection (open hepatectomy).
- Patient provides written informed consent to participate in the study.
Exclusion Criteria:
Severe coagulation profile derangement prior to surgery (defined as International Normalized Ratio [INR] > 1.5 or 2.0, or Platelet count [PLT] < 50 G/L or 100 G/L).
- Severe hepatic impairment (Child-Pugh Class C).
- Severe chronic obstructive pulmonary disease (COPD GOLD stage III-IV).
- Severe cardiac dysfunction with an ejection fraction (EF) < 35%.
- Severe obesity with a Body Mass Index (BMI) > 40 kg/m².
- Localized infection at the planned puncture/needle insertion site.
- Known allergy or hypersensitivity to local anesthetics (e.g., Ropivacaine) or opioids (e.g., Morphine).
- Pregnancy or current lactation.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Erector Spinae Plane Block Group
Patients will receive ultrasound-guided continuous bilateral erector spinae plane block at the T7 level with a programmed intermittent bolus (PIB) regimen of Ropivacaine 0.1% (18 mL/3h on the right side and 18 mL/3h on the left side) for 72 hours postoperatively, combined with systemic multimodal analgesia
|
Patients will receive ultrasound-guided continuous bilateral erector spinae plane block at the T7 level with a programmed intermittent bolus (PIB) regimen of Ropivacaine 0.1% (18 mL/3h on the right side and 18 mL/3h on the left side) for 72 hours postoperatively, combined with systemic multimodal analgesia
|
|
Comparateur actif: Thoracic Epidural Analgesia Group
Patients will receive a thoracic epidural catheter inserted at the T7-T8 interspace with a continuous basal infusion of Ropivacaine 0.1% at a rate of 5-8 mL/h for 72 hours postoperatively, combined with systemic multimodal analgesia
|
Patients will receive a thoracic epidural catheter inserted at the T7-T8 interspace with a continuous basal infusion of Ropivacaine 0.1% at a rate of 5-8 mL/h for 72 hours postoperatively, combined with systemic multimodal analgesia
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Postoperative Pain Intensity at Rest at 24 Hours
Délai: At 24 hours postoperatively
|
Postoperative pain intensity evaluated using the Numerical Rating Scale (NRS), where 0 represents no pain and 10 represents the worst imaginable pain.
The score will be recorded at rest exactly 24 hours after the completion of the surgery
|
At 24 hours postoperatively
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Cumulative Morphine Equivalent Consumption
Délai: From 0 to 24 hours postoperatively
|
The total amount of intravenous morphine equivalents (in milligrams) administered as rescue analgesia to the patient during the first 24 hours after surgery
|
From 0 to 24 hours postoperatively
|
|
Postoperative Pain Intensity at Rest and During Coughing up to 72 Hours
Délai: At 0, 1, 3, 6, 12, 48, and 72 hours postoperatively
|
Pain intensity scores assessed using the Numerical Rating Scale (NRS, 0-10) both at rest and during coughing at multiple scheduled postoperative time intervals
|
At 0, 1, 3, 6, 12, 48, and 72 hours postoperatively
|
|
Incidence of Postoperative Complications and Adverse Events
Délai: Up to 72 hours postoperatively
|
The percentage of patients experiencing technique-related complications (such as local hematoma, catheter dislodgement, block failure) or opioid-related side effects (including postoperative nausea and vomiting, pruritus, urinary retention), as well as pulmonary complications (atelectasis, pneumonia) and hemodynamic instability (hypotension, bradycardia)
|
Up to 72 hours postoperatively
|
|
Time to Gastrointestinal Recovery
Délai: Up to 72 hours postoperatively
|
Evaluation of bowel function recovery, measured by the time (in hours) from the end of surgery to the first passage of flatus (first anal exhaust), and the time (in hours) to the first tolerance of oral intake (solid or liquid food)
|
Up to 72 hours postoperatively
|
|
First Postoperative Night Sleep Quality
Délai: On the first postoperative night
|
The patient's subjective sleep quality during the first night after surgery, evaluated using a visual analog scale (VAS for sleep) or the Pittsburgh Sleep Quality Index (PSQI) subscale, where sleep disruption and total sleep duration are assessed
|
On the first postoperative night
|
|
Postoperative Length of Hospital Stay
Délai: From the day of surgery to hospital discharge (estimated up to 14 days)
|
The total number of days from the completion of the surgical procedure to the day the patient is officially discharged from the hospital, meeting predefined standard discharge criteria
|
From the day of surgery to hospital discharge (estimated up to 14 days)
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
15 juin 2026
Achèvement primaire (Réel)
15 août 2026
Achèvement de l'étude (Réel)
15 août 2026
Dates d'inscription aux études
Première soumission
8 juin 2026
Première soumission répondant aux critères de contrôle qualité
8 juin 2026
Première publication (Réel)
11 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
19 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
17 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- La douleur
- Manifestations neurologiques
- Complications postopératoires
- Processus pathologiques
- Tumeurs par site
- Tumeurs
- Tumeurs du système digestif
- Maladies du système digestif
- Maladies du foie
- Conditions pathologiques, signes et symptômes
- Signes et symptômes
- Douleur, Postopératoire
- La douleur aiguë
- Tumeurs du foie
- Régime, nourriture et nutrition
- Phénomènes physiologiques
- Nourriture et boissons
- Boissons
- Préparations de plantes
- Produits biologiques
- Mélanges complexes
- Thé
Autres numéros d'identification d'étude
- IRB-BMH-ĐT.RG-2026.12.Đ11
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
The individual patient data will not be shared publicly to maintain patient confidentiality and privacy in accordance with local institutional regulations.
The aggregated results will be published in the final thesis and scientific journals
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .