- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07601490
The Effect of Nerve Blocks on Analgesia in Breast Cancer Surgery (breast surgery)
Comparison of Postoperative Analgesic Efficacy of Serratus Posterior Superior Intercostal Plane Block and Serratus Anterior Plane Block in Modified Radical Mastectomy Surgery
Postoperative pain following modified radical mastectomy remains a significant clinical concern and may adversely affect patient recovery, opioid consumption, and overall patient satisfaction. Ultrasound-guided regional anesthesia techniques have gained increasing importance as part of multimodal analgesia strategies in breast surgery. The serratus anterior plane (SAP) block is a commonly used interfascial plane block for postoperative analgesia in thoracic and breast procedures. Recently, the serratus posterior superior intercostal plane (SPSIP) block has emerged as a novel regional anesthesia technique with potentially wider thoracic dermatomal spread and effective analgesic properties.
This prospective randomized controlled study aims to compare the postoperative analgesic efficacy of the SPSIP block and SAP block in patients undergoing modified radical mastectomy under general anesthesia. Patients will be randomly allocated into two groups to receive either ultrasound-guided SPSIP block or SAP block preoperatively. Primary outcomes will include postoperative pain scores and opioid consumption within the first 24 hours after surgery. Secondary outcomes will include time to first analgesic request, rescue analgesic requirements, intraoperative hemodynamic parameters, postoperative nausea and vomiting, block-related complications, and patient satisfaction.
The study is designed to evaluate whether SPSIP block provides superior postoperative analgesia compared with SAP block in modified radical mastectomy surgery.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
This prospective, randomized, controlled clinical study is designed to compare the postoperative analgesic efficacy of the ultrasound-guided Serratus Posterior Superior Intercostal Plane (SPSIP) block and Serratus Anterior Plane (SAP) block in patients undergoing modified radical mastectomy under general anesthesia. Postoperative pain after breast cancer surgery remains an important clinical problem and may negatively affect respiratory function, early mobilization, recovery quality, patient satisfaction, and postoperative opioid consumption. Effective perioperative analgesia is therefore an essential component of enhanced recovery protocols in breast surgery.
Regional anesthesia techniques have increasingly been incorporated into multimodal analgesia strategies to reduce opioid-related adverse effects and improve postoperative pain control. The SAP block is widely used in breast and thoracic surgery due to its ability to provide analgesia to the lateral thoracic wall through blockade of the lateral cutaneous branches of the intercostal nerves. However, recently described fascial plane blocks such as the SPSIP block may provide broader dermatomal spread and more effective thoracic analgesia. Despite growing interest in the SPSIP block, evidence regarding its analgesic efficacy in breast surgery remains limited.
The study will include adult female patients scheduled for elective modified radical mastectomy under general anesthesia. Following enrollment and randomization, patients will be allocated to receive either ultrasound-guided SPSIP block or SAP block preoperatively in addition to standardized general anesthesia and multimodal analgesia protocols. All regional blocks will be performed under sterile conditions using ultrasound guidance by experienced anesthesiologists. Standard intraoperative monitoring will be applied throughout the surgical procedure.
Perioperative anesthetic management will be standardized as much as possible to minimize confounding factors affecting postoperative pain outcomes. Intraoperative opioid administration, hemodynamic parameters, and anesthetic requirements will be recorded. Postoperative analgesia protocols, including rescue analgesic administration criteria, will also be standardized for all participants.
The primary aim of the study is to evaluate and compare postoperative analgesic effectiveness between SPSIP and SAP blocks. Analgesic efficacy will be assessed using postoperative pain scores at predefined time intervals and cumulative opioid consumption during the postoperative period. Additional perioperative parameters related to recovery and analgesic quality will also be evaluated to determine the clinical utility of these interfascial plane blocks in breast surgery.
This study is expected to contribute to the current literature regarding novel regional anesthesia techniques for breast surgery and may help define the role of SPSIP block as an alternative or superior analgesic approach compared with SAP block in modified radical mastectomy patients.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Dilek Metin Yamac, MD
- Numéro de téléphone: +905054959792
- E-mail: ddilekmetin@hotmail.com
Lieux d'étude
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Uskudar
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Istanbul, Uskudar, Turquie (Türkiye), 34668
- Health Sciences University 2. Sultan Abdülhamid Han Training and Research Hospital
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Contact:
- Dilek Metin Yamac, Medicine Doctor
- Numéro de téléphone: +90216 542 20 00
- E-mail: ddilekmetin@hotmail.com
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Female patients aged between 18 and 65 years
- American Society of Anesthesiologists (ASA) physical status I-III
- Body Mass Index (BMI) <35 kg/m²
- Normal International Normalized Ratio (INR) value and platelet count
- Normal liver and renal function tests
- Patients scheduled for elective modified radical mastectomy surgery
Exclusion Criteria:
- Bleeding diathesis
- Allergy to local anesthetic agents
- Suspected infection or inflammation at the planned block site
- ASA physical status IV or higher
- Long-term medication use due to chronic pain
- Advanced hepatic or renal failure
- Presence of severe pulmonary disease
- Use of any opioid medication within 24 hours before surgery
- Cognitive impairment
- Patients undergoing revision surgery
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Serratus Posterior Superior Intercostal Plane (SPSIP) block
Participants assigned to this group will receive an ultrasound-guided Serratus Posterior Superior Intercostal Plane (SPSIP) block before induction of general anesthesia for modified radical mastectomy surgery.
The block will be performed under sterile conditions by an experienced anesthesiologist using ultrasound guidance.
Following the regional block procedure, standardized general anesthesia and postoperative multimodal analgesia protocols will be applied.
Postoperative pain scores, opioid consumption, rescue analgesic requirements, and perioperative adverse events will be recorded and evaluated.
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Ultrasound-guided Serratus Posterior Superior Intercostal Plane (SPSIP) block performed preoperatively for postoperative analgesia in modified radical mastectomy surgery.
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Comparateur actif: Serratus Anterior Plane (SAP) block
Participants assigned to this group will receive an ultrasound-guided Serratus Anterior Plane (SAP) block before induction of general anesthesia for modified radical mastectomy surgery.
The block will be performed under sterile conditions by an experienced anesthesiologist using ultrasound guidance.
Following the regional block procedure, standardized general anesthesia and postoperative multimodal analgesia protocols will be applied.
Postoperative pain scores, opioid consumption, rescue analgesic requirements, and perioperative adverse events will be recorded and evaluated.
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Ultrasound-guided Serratus Anterior Plane (SAP) block performed preoperatively for postoperative analgesia in modified radical mastectomy surgery.
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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 assessed by Visual Analog Scale (VAS)
Délai: At postoperative 1, 2, 4, 8, 12, and 24 hours after surgery
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Postoperative pain intensity will be evaluated using the Visual Analog Scale (VAS), a 10-point scale ranging from 0 to 10, where 0 indicates "no pain" and 10 indicates "the worst imaginable pain."
VAS scores at rest and during movement will be recorded and compared between patients receiving ultrasound-guided superior posterior serratus intercostal plane (SPSIP) block and serratus anterior plane (SAP) block following modified radical mastectomy surgery.
Higher VAS scores indicate greater pain severity and poorer analgesic efficacy.
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At postoperative 1, 2, 4, 8, 12, and 24 hours after surgery
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Intraoperative remifentanil consumption
Délai: During surgery
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Total intraoperative remifentanil consumption will be recorded and compared between the SPSIP block group and SAP block group.
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During surgery
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Total postoperative tramadol consumption within 24 hours
Délai: First 24 hours after surgery
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Total tramadol consumption during the first 24 postoperative hours will be recorded to evaluate postoperative opioid requirements in both groups.
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First 24 hours after surgery
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Postoperative nausea and vomiting (PONV) scores
Délai: First 24 hours after surgery
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Postoperative nausea and vomiting will be assessed using a standardized Postoperative Nausea and Vomiting (PONV) severity scale ranging from 0 to 3, where 0 indicates no nausea or vomiting, 1 indicates mild nausea, 2 indicates severe nausea or a single episode of vomiting, and 3 indicates multiple episodes of vomiting.
PONV scores will be recorded and compared between groups during the postoperative period.
Higher scores indicate more severe postoperative nausea and vomiting and therefore worse clinical outcomes.
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First 24 hours after surgery
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Collaborateurs et enquêteurs
Publications et liens utiles
Publications générales
- Arik E, Zengin M, Seker G, Kucuk O, Gungordu E, Ozguner Y, Alagoz A, Ergil J. Is the serratus posterior superior intercostal plane block a viable alternative to the erector spinae plane block for postoperative analgesia in breast surgery? A prospective, randomized trial. BMC Anesthesiol. 2025 Nov 29;26(1):11. doi: 10.1186/s12871-025-03531-y.
- Baytar C, Aktas B, Aydin BG, Piskin O, Cakmak GK, Ayoglu H. The effects of ultrasound-guided serratus anterior plane block on intraoperative opioid consumption and hemodynamic stability during breast surgery: A randomized controlled study. Medicine (Baltimore). 2022 Sep 2;101(35):e30290. doi: 10.1097/MD.0000000000030290.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
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
Mots clés
Autres numéros d'identification d'étude
- SBU-ANESTEZİ-DMY-05
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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