Effect of Intercostal Nerve Block With Ropivacaine Combined With Mecobalamine on Chronic Pain After Thoracic Surgery
1 janvier 2020 mis à jour par: Han Yuan, Xuzhou Medical University
Effect of Intercostal Nerve Block With Ropivacaine Combined With Mecobalamine on Chronic Pain After Thoracic Surgery -- a Single-center Randomized, Double-blind Controlled Trial
This project intends to investigate the effects of intercostal nerve block with ropivacaine combined with mecobalamin on chronic post-surgical pain (CPSP) in thoracic postoperative patients.
Related clinical characteristics of postoperative chronic pain.
The results of the study provide clinicians with a simple and inexpensive new method of preventing CPSP, in order to prevent the occurrence of CPSP and reduce the incidence of CPSP, thereby reducing CPSP to patients and their families, hospitals.
And public resources.
Aperçu de l'étude
Statut
Inconnue
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Anticipé)
124
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
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Jiangsu
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Xuzhou, Jiangsu, Chine, 225000
- Department of Anesthesiology of the Affiliated Hospital of Xuzhou Medical University
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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
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Age ≥18 years old, conscious;
- ASA class Ⅰ ~ Ⅲ;
- Thoracoscopic lobectomy was proposed;
- The han nationality;
- Native speaker of Chinese;
- Agree to participate in this study and sign the informed consent.
Exclusion Criteria:
- Patients allergic to meccobalamin or ropivacaine;
- Patients with previous history of chest surgery;
- Patients with tumor invasion of chest wall, abscess, tumor intercostal neuropathy or pathological rib fracture;
- Patients with a history of analgesic addiction or abuse, epilepsy, one or other neurological disease;
- Diabetic patients;
- Patients who need other drugs for pain relief but have not completed treatment or have completed treatment.
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: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: ropivacaine combined with mecobalamine
Intercostal nerve block with 0.5% ropivacaine combined with mecobalamine (0.5mg).
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In the experimental group, the surgeons used 0.5% ropivacaine combined with mecobalamine (0.5mg) before the operation to perform intercostal nerve block in the operating incision, closed thoracic drainage incision and one intercostal nerve block in each upper and lower costal cavity, and injected 5ml in each intercostal nerve block.In the control group, surgeons used 0.5% ropivacaine alone before the operation to perform intercostal nerve block through the operating incision, closed thoracic drainage incision and one intercostal nerve block in each upper and lower costal cavity.
5ml was injected into each intercostal nerve block.
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Comparateur actif: ropivacaine
Intercostal nerve block with 0.5% ropivacaine alone.
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In the experimental group, the surgeons used 0.5% ropivacaine combined with mecobalamine (0.5mg) before the operation to perform intercostal nerve block in the operating incision, closed thoracic drainage incision and one intercostal nerve block in each upper and lower costal cavity, and injected 5ml in each intercostal nerve block.In the control group, surgeons used 0.5% ropivacaine alone before the operation to perform intercostal nerve block through the operating incision, closed thoracic drainage incision and one intercostal nerve block in each upper and lower costal cavity.
5ml was injected into each intercostal nerve block.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Incidence of chronic pain after chest surgery
Délai: At the 3rd month after surgery
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The incidence of chronic pain after chest surgery was measured by NRS(numeric rating scales) at the 3rd month after surgery.For pain evaluation,we used the 11 point numeric rating scale(NRS),where an NRS scores of 0 represented "no pain" and a score of 10 represented "worst pain imaginable".
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At the 3rd month after surgery
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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The incidence of acute pain after chest surgery
Délai: 24 to 72 hours after surgery
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An NRS score was performed 24 to 72 hours after surgery to determine the incidence of acute pain after thoracic surgery.For pain evaluation,we used the 11 point numeric rating scale(NRS),where an NRS scores of 0 represented "no pain" and a score of 10 represented "worst pain imaginable".
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24 to 72 hours after surgery
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Incidence of postoperative neuropathic pain
Délai: At the 3rd month after surgery
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The incidence of neuropathic pain was measured by DN4 scale at the 3rd month after surgery.Douleur Neuropathique 4 (DN4) is a screening questionnaire to help identify neuropathic pain (NP) in clinical practice and research,where a DN4 scores greater than or equal to 4 represented the patients had "postoperative neuropathic pain".
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At the 3rd month after surgery
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Incidence of other postoperative complications
Délai: At the 3rd month after surgery
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Postoperative complications included that pulmonary complications, delirium, intestinal obstruction, pulmonary embolism, acute respiratory failure, acute renal failure, incision infection, cerebrovascular accident and other complications related to surgery.
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At the 3rd month after surgery
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Incidence of readmission within 30 days after surgery
Délai: At the 30 days after surgery
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The incidence and the reason of readmission within 30 days after surgery was obtained through postoperative follow-up.
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At the 30 days after surgery
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Incidence of death within 30 days after surgery
Délai: At the 30 days after surgery
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The incidence and the reason of death within 30 days after surgery was obtained through postoperative follow-up
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At the 30 days after surgery
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Length of stay
Délai: At the 3rd month after surgery
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The total length of hospital stay.
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At the 3rd month after surgery
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Cost of stay
Délai: At the 3rd month after surgery
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The total cost of hospital stay.
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At the 3rd month after surgery
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icu length of stay
Délai: At the 3rd month after surgery
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The number of hours of postoperative stay in ICU.
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At the 3rd month after surgery
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Incidence of secondary operation
Délai: At the 3rd month after surgery
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Whether the patient has a second operation and the reason and the incidence of this operation.
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At the 3rd month after surgery
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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 (Anticipé)
1 janvier 2020
Achèvement primaire (Anticipé)
30 juin 2020
Achèvement de l'étude (Anticipé)
30 novembre 2020
Dates d'inscription aux études
Première soumission
30 novembre 2019
Première soumission répondant aux critères de contrôle qualité
1 janvier 2020
Première publication (Réel)
3 janvier 2020
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
3 janvier 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
1 janvier 2020
Dernière vérification
1 janvier 2020
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- XYFY2019-KL169-01
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
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