- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef 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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
-
Sakarya, Turkije (Türkiye)
- Werving
- Sakarya University-Anesthesiology and Reanimation Department
-
Contact:
- Mehmet Gökhan Küçük, MD
- Telefoonnummer: +905523940727
- E-mail: mgokhank09@gmail.com
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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.
|
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.
|
|
Experimenteel: 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.
|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Ease of block application (procedure difficulty score)
Tijdsspanne: Immediately after block performance
|
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.
|
Immediately after block performance
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Postoperative pain score at 24 hours
Tijdsspanne: 24 hours postoperatively
|
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.
|
24 hours postoperatively
|
|
Quality of recovery at 24 hours
Tijdsspanne: 24 hours postoperatively
|
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.
|
24 hours postoperatively
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- SAU-ANE-MGK-01
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .