- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Sakarya, Turchia (Türkiye)
- Reclutamento
- Sakarya University-Anesthesiology and Reanimation Department
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Contatto:
- Mehmet Gökhan Küçük, MD
- Numero di telefono: +905523940727
- Email: mgokhank09@gmail.com
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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.
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Sperimentale: 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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Ease of block application (procedure difficulty score)
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Postoperative pain score at 24 hours
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
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Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- SAU-ANE-MGK-01
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .