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- Registre américain des essais cliniques
- Essai clinique NCT07561853
Serratus Posterior Superior vs Erector Spinae Plane Block for Breast Surgery
Comparison of Serratus Posterior Superior Intercostal Plane Block and Erector Spinae Plane Block in Breast Surgery in Terms of Ease of Application and Patient Comfort
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Postoperative pain following mastectomy is a common and clinically significant issue that not only reduces patient comfort but may also hinder early mobilization and rehabilitation, thereby negatively impacting overall functional outcomes. Effective postoperative analgesia is therefore a key component of perioperative care in breast surgery.
A variety of analgesic techniques, including systemic analgesics and regional anesthesia methods, are currently employed to manage postoperative pain. Among these, ultrasound-guided fascial plane blocks have gained increasing popularity due to their relative safety, simplicity, and effectiveness. The serratus posterior superior intercostal plane (SPSIP) block and the erector spinae plane (ESP) block are two such regional techniques used for thoracic analgesia.
In our clinical practice, both SPSIP and ESP blocks are routinely used for patients undergoing mastectomy. However, comparative data regarding their ease of application and impact on patient comfort are limited. Ease of application is an important consideration for anesthesiologists, particularly in busy clinical settings, while patient comfort during block placement is a critical but often underreported outcome.
The primary aim of this study is to compare SPSIP block and ESP block in patients undergoing mastectomy in terms of ease of application and patient comfort during the procedure. Secondary considerations may include block-related characteristics and their contribution to postoperative recovery.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Sakarya, Turquie (Türkiye)
- Recrutement
- Sakarya University-Anesthesiology and Reanimation Department
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Contact:
- Mehmet Gökhan Küçük, MD
- Numéro de téléphone: +905523940727
- E-mail: mgokhank09@gmail.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 Gender
- Mastectomy operation
- 25-65 years
- American Society Anestheosiology Physical Status I-III
Exclusion Criteria:
- American Society Anestheosiology Physical Status IV
- Alcohol or substance abuse
- Known allergy to local anesthetics or opioids
- Severe psychiatric disorders
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Serratus Posterior Superior Intercostal Plane Block Group
Participants in this group will receive an ultrasound-guided serratus posterior superior intercostal plane (SPSIP) block for postoperative analgesia following mastectomy.
The block will be performed under standardized conditions prior to surgery according to the study protocol.
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Participants in this group will receive an ultrasound-guided serratus posterior superior intercostal plane (SPSIP) block for postoperative analgesia following mastectomy.
The block will be performed under standardized conditions prior to surgery according to the study protocol.
|
|
Expérimental: Erector Spinae Plane Block Group
Participants in this group will receive an ultrasound-guided erector spinae plane (ESP) block for postoperative analgesia following mastectomy.
The block will be performed under standardized conditions prior to surgery according to the study protocol.
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Participants in this group will receive an ultrasound-guided erector spinae plane (ESP) block for postoperative analgesia following mastectomy.
The block will be performed under standardized conditions prior to surgery according to the study protocol.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Ease of block application (procedure difficulty score)
Délai: Immediately after block performance
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The ease of application of the block will be evaluated using a 10-point numerical rating scale (0-10), where lower scores indicate easier application and higher scores indicate greater procedural difficulty.
The score will be assigned by the anesthesiologist performing the block immediately after completion of the procedure.
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Immediately after block performance
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Postoperative pain score at 24 hours
Délai: 24 hours postoperatively
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Postoperative pain intensity will be assessed using a 10-cm Visual Analog Scale (0 = no pain, 10 = worst imaginable pain) at 24 hours after surgery.
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24 hours postoperatively
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Quality of recovery at 24 hours
Délai: 24 hours postoperatively
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Postoperative recovery quality will be assessed using the Quality of recovery (QoR-15) questionnaire at 24 hours after surgery.
The total score ranges from 0 to 150, with higher scores indicating better recovery.
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24 hours postoperatively
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- SAU-ANE-MGK-01
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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