Perfusion continue de lidocaïne via un tube de drainage thoracique fermé pour le contrôle de la douleur après une résection pulmonaire partielle thoracoscopique
Effets de la perfusion continue de lidocaïne via un tube de drainage thoracique fermé sur l'analgésie postopératoire chez les patients subissant une résection pulmonaire partielle thoracoscopique : un essai clinique contrôlé randomisé monocentrique
The goal of this clinical trial is to learn about the effects on postoperative analgesia of continuous lidocaine infusion via closed chest drainage tube for patients undergoing thoracoscopic partial lung resection. The main questions it aims to answer are:
- To explore whether continuous lidocaine pumping via closed chest drainage tube has good analgesic and anti-inflammatory effects for patients undergoing partial thoracoscopic pneumonectomy.
- Whether the multimodal analgesia combined with continuous lidocaine pump can reduce the postoperative application of opioids, reduce the occurrence of postoperative complications, and promote the recovery of postoperative lung function and accelerate recovery.
For participants who undergoing the thoracoscopic partial lung resection with postoperative indwelling drainage tube, the epidural tube fixed in the drainage tube is connected to the completed infusion pump (marking the chest drain for analgesia). The comparison group only accept the intravenous analgesia after surgery.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
At present, multimodal analgesia has been the most commonly used approaches for the treatment of postoperative pain of thoracic surgery, including steroidal anti-inflammatory drugs, administration of opioid, and local anesthesia.
The investigators found that continuous lidocaine analgesia with local anesthesia through thoracic closed drainage tube could improve postoperative pain caused by drainage tube retention, reduce postoperative pain score, and improve postoperative recovery of respiratory function in patients. In the protocol, lidocaine was continuously pumped with a superficial anesthetic effect on the pleura, while mucosal absorption was almost equivalent to intravenous infusion, so its systemic anti-inflammatory effect is also explored.
In the protocol，participants will be randomized in a 1:1 ratio to the control or experimental groups. The experimental group received a continuous infusion of lidocaineThe experimental group used 2% lidocaine 100ml, and the control group was the conventional treatment group. The control group received only standard intravenous analgesia。In addition to receiving simple intravenous analgesia, the experimental group also received continuous infusion of lidocaine in the pleural cavity.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Shandong
-
Jinan, Shandong, Chine
- Qilu Hospital
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- participants ages 18-70 years.
- participants undergoing thoracoscopic partial lung resection with an indwelling drainage tube after surgery.
- American Society of Anesthesiologists classification (ASA)I-III.
Exclusion Criteria:
- severe heart failure, cardiac arrhythmias,the New York Heart Association(NYHA) classification≥III.
- hypersensitivity to lidocaine,History of local anesthetic poisoning.
- severe renal or hepatic dysfunction.
- body mass index (BMI)>35 kg m-2.
- severe pleural adhesions.
Plan d'étude
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 |
|---|---|
|
Expérimental: Lidocaine (intrapleural continuous infusion) + reduced-dose sufentanil PCIA
Patients receive continuous intrapleural lidocaine infusion via the closed chest drainage tube (pulse 1 mL/30 min + continuous 2 mL/h) combined with reduced-dose sufentanil patient-controlled intravenous analgesia (PCIA, 1.0-1.5 µg/kg for 48 h). |
Continuous intrapleural infusion via epidural tube fixed in the closed chest drainage tube, connected to an electronic analgesic pump (pulse 1 mL/30 min + continuous 2 mL/h). Patient-controlled intravenous analgesia (PCIA): reduced dose 1.0-1.5 µg/kg in the lidocaine arm, standard dose 2.0-2.5 µg/kg in the control arm, both for 48 h. |
|
Comparateur actif: Standard-dose sufentanil PCIA
Patients receive standard-dose sufentanil PCIA (2.0-2.5 µg/kg for 48 h) alone. |
Patient-controlled intravenous analgesia (PCIA): reduced dose 1.0-1.5 µg/kg in the lidocaine arm, standard dose 2.0-2.5 µg/kg in the control arm, both for 48 h. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
postoperative pain score（NRS）
Délai: Day 1
|
The primary outcome is the incidence of a numeric rating scale (NRS) pain score > 3 on coughing/movement at 24 hours postoperatively (movement-evoked pain only). |
Day 1
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Changes in postoperative pain
Délai: Day 2
|
Changes in postoperative pain score (NRS) at 12h and 48h until extubation. The full name of NRS score is Numerical Rating Scale. The minimum value of NRS score is 0 and the maximum value is 10. Patients can score themselves according to the pain level corresponding to the number, A score of 0 represents painless, 1-3 represents mild pain, 4-6 represents moderate pain and should be intervened, 7-10 represents severe pain and requires urgent treatment. |
Day 2
|
|
the use of flurbiprofen axetil
Délai: Day 3
|
the amount of rescue analgesic drugs flurbiprofen axetil used |
Day 3
|
|
the use of dolantin
Délai: Day 3
|
the amount of rescue analgesic drugs dolantin used |
Day 3
|
|
the use of opioids
Délai: Day 2
|
total amount of opioid use within 48h after surgery |
Day 2
|
|
postoperative adverse events
Délai: Day 3
|
the incidence of nausea, vomiting, and vertigo after surgery |
Day 3
|
|
the amount of postoperative wound drainage
Délai: Day 3
|
total amount of fluid drained after surgery |
Day 3
|
|
C-reactive protein
Délai: Day 1
|
The inflammatory marker of participants will be test after surgery |
Day 1
|
|
interleukin-6
Délai: Day 1
|
The inflammatory marker of participants will be test after surgery |
Day 1
|
|
postoperative delusion
Délai: Day 3
|
The incidence of postoperative delusion. |
Day 3
|
|
drainage extraction
Délai: up to 24 hours (before extubation)
|
The time taken for the patient to remove the drain after surgery |
up to 24 hours (before extubation)
|
|
ICU stay time
Délai: From date of ICU admission until the date of leaving ICU, assessed up to 5 days.
|
The length of time the patient remains in the ICU. |
From date of ICU admission until the date of leaving ICU, assessed up to 5 days.
|
|
postoperative pulmonary complications
Délai: Day 3
|
The probability of patients acquiring pulmonary complications after surgery. |
Day 3
|
|
hospital length of stay
Délai: From date of hospital admission until the date of discharge,assessed up to 15 days.
|
The time between hospital admission and discharge |
From date of hospital admission until the date of discharge,assessed up to 15 days.
|
|
healing rate of drainage wound
Délai: Day 21
|
The healing rate of drainage wound at 21 days after surgery. |
Day 21
|
|
readmission rate
Délai: Month 1
|
The readmission rate of patients in one month after surgery. |
Month 1
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Publications générales
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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
Termes MeSH pertinents supplémentaires
- La douleur
- Manifestations neurologiques
- Maladies du système nerveux
- Complications postopératoires
- Processus pathologiques
- Manifestations neurocomportementales
- Troubles de la perception
- Conditions pathologiques, signes et symptômes
- Signes et symptômes
- Douleur, Postopératoire
- Agnosie
- Produits chimiques organiques
- Composés hétérocycliques, 1 anneau
- Composés hétérocycliques
- Anilides
- Amides
- Composés aniline
- Amines
- Acétanilides
- Pipéridines
- Fentanyl
- Lidocaïne
- Sufentanil
Autres numéros d'identification d'étude
- KYLL-202210-071-1
Informations sur les médicaments et les dispositifs, documents d'étude
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