- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07577908
Analgesic Efficiency of SIPSPB vs ICNB in VATS Surgery
Comparison Of The Analgesic Effectiveness Of Ultrasonography-Guided Serratus Posterıor Superior Intercostal Plane (SPSIP) Block And Intercostal Nerve (ICN) Block In Video-Assisted Thoracoscopic Surgery Patients
Aperçu de l'étude
Statut
Description détaillée
In this prospective observational study, patients included in the study will receive Serratus Posterior Superior Intercostal Plane (SPSIP) block and Intercostal Nerve (ICN) block for postoperative analgesia at the end of surgery. The SPSIP block will be performed by the anesthesiologist under ultrasound guidance immediately after skin closure and before extubation, while the ICN block will be performed by the surgeon under direct vision immediately before skin closure.
At the end of surgery, patients will receive 1000 mg paracetamol and 50 mg dexketoprofen during skin closure. Upon arrival at the recovery room, each patient will be connected to a patient-controlled analgesia (PCA) pump containing tramadol. At postoperative reassessment, patients with a Numerical Pain Rating Scale (NPRS) score greater than 4 despite PCA use will receive a rescue analgesic dose of 50 mg dexketoprofen.
Postoperative pain intensity will be assessed using the NPRS (Numerical Pain Rating Scale) at 1, 4, 6, 12, 18, and 24 hours postoperatively, both at rest and during coughing. Total opioid consumption, rescue analgesic use, and postoperative complications will be recorded.
Patients will be informed about their level of surgical satisfaction 24 hours after surgery, and this information will be recorded.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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İzmit, Turquie (Türkiye)
- Kocaeli City Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Aged 18-80 years,
- American Society of Anesthesiologists (ASA) physical status I-III
- Patients who have provided informed consent to participate in the study
Exclusion Criteria:
- Patients who refuse to participate in the study by not signing the informed consent
- Patients classified as ASA > 3, according to the system established by the American Society of Anesthesiologists
- Patients unable to understand the use of the NPR Scale or the PCA device that will be used for postoperative analgesia
- Coagulation disorders or anticoagulant therapy contraindicating regional anesthesia
- Patients with allergies to analgesic and/or anesthetic drugs
- Infection at the block injection site
- Patients whose surgical procedure is intraoperatively converted to an open pulmonary resection
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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Group SPSIP Block
In patients meeting the inclusion criteria for the study, an ultrasound-guided interfacial plane block is applied between the posterior superior serratus muscle and the underlying ribs in patients undergoing SPSIP block after VATS.
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Group ICN Block
Patients meeting the inclusion criteria for the study who will undergo intercostal nerve block after VATS will have a total of 10 ml of 0.5% bupivacaine applied to two segments (upper and lower segments of the incision line) under direct vision by the surgeon while the patient is in the lateral decubitus position at the end of the operation and immediately before skin closure.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Postoperative pain intensity
Délai: 24 hours after the end of surgery
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In both study groups, postoperative pain intensity at rest and with coughing was measured using the Numerical Pain Rating Scale (NPRS), a numerical scale ranging from 0 to 10 (0 meaning no pain, 10 meaning the most severe pain imaginable).
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24 hours after the end of surgery
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Score de satisfaction des patients
Délai: À la 24e heure post-opératoire
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évalué à l'aide d'une échelle de Likert en 5 points (1=très insatisfait, 5=très satisfait)
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À la 24e heure post-opératoire
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Total opioid drug consumption
Délai: 24 hours after the end of surgery
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The total amount of opioid doses administered via a Patient Controlled Analgesia (PCA) device in the first 24 hours after surgery
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24 hours after the end of surgery
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Consumption of rescue analgesics
Délai: 24 hours after the end of surgery
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The total dose of dexketoprofen required by the patient during each specified time interval in the first 24 hours after surgery.
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24 hours after the end of surgery
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Postoperative Complications
Délai: 24 hours after the end of surgery
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Postoperative complications such as nausea, vomiting or other adverse events will be recorded
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24 hours after the end of surgery
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Ayşe Z Turan Cıvraz, Assoc. Prof., Kocaeli City Hospital
Publications et liens utiles
Publications générales
- Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Sakul BU, Korkmaz AO, Bozkurt NN, De Cassai A, Torres AJ, Elsharkawy H, Alici HA. Serratus Posterior Superior Intercostal Plane Block: A Technical Report on the Description of a Novel Periparavertebral Block for Thoracic Pain. Cureus. 2023 Feb 3;15(2):e34582. doi: 10.7759/cureus.34582. eCollection 2023 Feb.
- Avci O, Gundogdu O, Balci F, Tekcan MN, Ozbey M. Efficacy of serratus posterior superior intercostal plane block (SPSIPB) on post-operative pain and total analgesic consumption in patients undergoing video-assisted thoracoscopic surgery (VATS): A double-blinded randomised controlled trial. Indian J Anaesth. 2023 Dec;67(12):1116-1122. doi: 10.4103/ija.ija_589_23. Epub 2023 Dec 13.
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
Autres numéros d'identification d'étude
- 250125
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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