- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07647367
Ultrasound Guided Subtransverse Interligamentary Block Versus Paravertebral Block for Quality of Recovery After Modified Radical Mastectomy
9. Juni 2026 aktualisiert von: Mai Salah Salem, Tanta University
Ultrasound-Guided Subtransverse Interligamentary Plane Block Versus Thoracic Paravertebral Block for Quality of Recovery After Modified Radical Mastectomy: A Randomized Non-Inferiority Trial
This prospective randomized controlled double blinded non-inferiority study will be carried out in Tanta University Hospitals for duration of 6 months from June 2026 to December 2026 on 60 female patients scheduled for unilatral modified radical mastectomy under general anesthesia.
Studienübersicht
Status
Noch keine Rekrutierung
Intervention / Behandlung
Detaillierte Beschreibung
Breast carcinoma is a common malignancy in females, with modified radical mastectomy (MRM) being the most frequently performed surgery.
Surgical intervention is accompanied by significant challenges such as postoperative pain and stress, potentially leading to prolonged hospitalizations and complications.
Previous studies had demonstrated that thoracic paravertebral block (TPVB) was effective in diminishing opioid requirements for patients undergoing breast surgery.
TPVB is technically challenging, requiring skilled healthcare professionals and the narrow paravertebral space, located between the superior costotransverse ligament (SCTL) and the parietal pleura, poses a risk of inadvertent pleural puncture and vascular damage, and increased the potential for pneumothorax and haematoma.
The Subtransverse process Interligamentary (STIL) plane block is a recently introduced technique that holds promise as an alternative to TPVB.
STIL plane block specifically targets the region adjacent to the paravertebral space, rather than directly penetrating it, which theoretically diminishes the potential risks of inadvertent pneumothorax and hematoma compared with TPVB.
Additionally, due to its close anatomical proximity to the paravertebral space, the STIL plane block may facilitate a more straightforward dispersion of local anaesthetics into this area.
Research has also confirmed that the block achieved with STIL plane block is effective in providing adequate pain relief for breast surgeries.
Also it was associated with decreased postoperative opioid consumption compared to the ESP block in patients undergoing MRM.
With the improvement of anaesthesia technology, the quality of patient recovery is no longer solely measured by the success of the surgery or the discharge rate, but is increasingly oriented towards a "patient-centered" approach that focuses on the safety, comfort, and overall quality of recovery throughout the perioperative period.
In light of the growing emphasis on improving postoperative quality of recovery while ensuring patient safety, we hypothesize that the STIL plane block will demonstrate non-inferiority to the thoracic PVB in terms of postoperative quality of recovery and analgesia in patients undergoing MRM.
Studientyp
Interventionell
Einschreibung (Geschätzt)
60
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Mai Salah Salem, MD anesthesia, SIC
- Telefonnummer: 002 01061107658
- E-Mail: mai.salah@med.tanta.edu.eg
Studienorte
-
-
-
Tanta, Ägypten, 31527
- Tanta university hospital
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
Inclusion Criteria:
- Adult female patients aged 18 to 65 years with American Society of Anesthesiologists (ASA) Physical Status I - III, who were scheduled for unilateral MRM surgery under general anesthesia and able to understand and complete the QoR-15 questionnaire
Exclusion Criteria:
• Patients declined to participate in the trial.
- History of allergy to the used local anesthetic (LA) drugs.
- Patients with cutaneous lesions at the needle entry point.
- Coagulopathy or current anticoagulant therapy contraindicating regional block.
- Patients with severe hepatic, renal, cardiac, or respiratory disease.
- Psychiatric or cognitive disorder interfering with QoR-15 assessment
- Chronic opioid use or chronic pain syndrome.
- Failed block.
- Morbid obesity (body mass index >40 kg/m2)
- Intraoperative major complications requiring postoperative ICU admission.
- Pregnancy
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: subtransverse interligamentary plane block
Patients will receive ultrasound-guided subtransverse interligamentary plane block with local anesthetic mixture (20 mL 0.25% bupivacaine, 100 micrograms of fentanyl (2ml))
|
Patients will receieve u;trasound guided subtransverse interligamentary plane block
Andere Namen:
|
|
Aktiver Komparator: Thoracic paravertebral block
Patients will receive ultrasound- guided thoracic paravertebral block with local anesthetic mixture (20 mL 0.25% bupivacaine, 100 micrograms of fentanyl (2ml))
|
Patients will receieve ultrasound guided thoracic paravertebral block
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Postoperative quality of recovery
Zeitfenster: It will be measured 24 hours after surgery
|
Postoperative quality of recovery assessed using the Quality of Recovery-15 questionnaire 24 hours after surgery
|
It will be measured 24 hours after surgery
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Postoperative pain score
Zeitfenster: It will be measured at rest and during arm movement at 0,2,6,12,24 hours postoperatively
|
Postoperative pain score using numerical rating scale (NRS) score The NRS is an 11-point pain scale ranging from 0 to 10, where 0 means no pain and 10 means the worst imaginable pain.
Participants are asked to rate their pain intensity by choosing the number that best represents their pain level.
|
It will be measured at rest and during arm movement at 0,2,6,12,24 hours postoperatively
|
|
Time to first rescue analgesia
Zeitfenster: Postoperatively the time interval from the end of surgery until need of rescue analgesia will be recorded
|
Time interval from the end of surgery until need of rescue analgesia
|
Postoperatively the time interval from the end of surgery until need of rescue analgesia will be recorded
|
|
Total postoperative opioid consumption in the first 24 hours
Zeitfenster: Total needed postoperative opioid dosing during the first 24 hours will recorded
|
Total postoperative opioid consumption in the first 24 hours will be recorded
|
Total needed postoperative opioid dosing during the first 24 hours will recorded
|
|
Incidence of postoperative nausea and vomiting
Zeitfenster: Postoperative incidence of postoperative nausea and vomiting will be recorded during the first 24 hours
|
Postoperative incidence of postoperative nausea and vomiting will be recorded during the first 24 hours
|
Postoperative incidence of postoperative nausea and vomiting will be recorded during the first 24 hours
|
|
The degree of patient satisfaction
Zeitfenster: it will be recorded postoperatively and 24 hours after surgery
|
The degree of patient satisfaction using level of satisfaction regarding the analgesia regimen using a 5 point Likert scale, where 1 indicates "extremely dissatisfied", 2 "unsatisfied", 3 "unsure", 4 "satisfied", and 5 "extremely satisfied"
|
it will be recorded postoperatively and 24 hours after surgery
|
|
Block performance time
Zeitfenster: Block performance time from the start of space visualization by ultrasound until the end of local anesthetic injection
|
Block performance time from the start of space visualization by ultrasound until the end of local anesthetic injection will be recorded
|
Block performance time from the start of space visualization by ultrasound until the end of local anesthetic injection
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- Arun N, Singh R, Kumar M. Direct Pectoral Nerve Block versus Ultrasound-Guided Paravertebral Block for Analgesia and Improved Recovery after Modified Radical Mastectomy: A Randomized Clinical Trial. Sri Lankan Journal of Anaesthesiology. 2026;34(1).
- Ince I, Dostbil A, Ozmen O, Aksoy M, Karadeniz E. Subtransverse process interligamentary (STIL) plane block for postoperative pain management after breast surgery. J Clin Anesth. 2020 May;61:109649. doi: 10.1016/j.jclinane.2019.109649. Epub 2019 Nov 17. No abstract available.
- Kilicaslan A, Sarkilar G, Altinok T, Tulgar S. A novel ultrasound-guided technique in peri-paravertebral area: Subtransverse process interligamentary (STIL) plane block: The game has not ended yet. J Clin Anesth. 2020 Mar;60:76-77. doi: 10.1016/j.jclinane.2019.08.047. Epub 2019 Aug 30. No abstract available.
- Ardon AE, Lee J, Franco CD, Riutort KT, Greengrass RA. Paravertebral block: anatomy and relevant safety issues. Korean J Anesthesiol. 2020 Oct;73(5):394-400. doi: 10.4097/kja.20065. Epub 2020 Mar 16.
- Gurkan Y, Aksu C, Kus A, Yorukoglu UH. Erector spinae plane block and thoracic paravertebral block for breast surgery compared to IV-morphine: A randomized controlled trial. J Clin Anesth. 2020 Feb;59:84-88. doi: 10.1016/j.jclinane.2019.06.036. Epub 2019 Jul 4.
- Ferlay J, Colombet M, Soerjomataram I, Parkin DM, Pineros M, Znaor A, Bray F. Cancer statistics for the year 2020: An overview. Int J Cancer. 2021 Apr 5. doi: 10.1002/ijc.33588. Online ahead of print.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
1. Juni 2026
Primärer Abschluss (Geschätzt)
1. Dezember 2026
Studienabschluss (Geschätzt)
1. Januar 2027
Studienanmeldedaten
Zuerst eingereicht
9. Juni 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
9. Juni 2026
Zuerst gepostet (Tatsächlich)
15. Juni 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
15. Juni 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
9. Juni 2026
Zuletzt verifiziert
1. Juni 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- 36265PR77/5/26
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
JA
Beschreibung des IPD-Plans
The data will be available upon a reasonable request from the corresponding author
IPD-Sharing-Zeitrahmen
The data will be available upon a reasonable request from the corresponding author after the end of the study for 1 year
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Subtransverse interligamentary plane block (STIL)
-
Ankara Etlik City HospitalNoch keine Rekrutierung
-
Samsun UniversityAbgeschlossenQuerabdominisebene (TAP) Block gegen Transversalis Fascia -Ebene (TFPB) nach der KaiserschnittabgabeKaiserschnitt | Akute SchmerzbehandlungTruthahn
-
Tanta UniversityRekrutierungKaiserschnitt | Transversalis-Faszien-Ebenenblock | Intrathekales DexmedetomidinÄgypten
-
Atatürk Chest Diseases and Chest Surgery Training...RekrutierungSchmerzen, postoperativ | Block der vorderen Serratus-Ebene | Thoraxchirurgie, videoassistiert | Lokale BetäubungTruthahn
-
Ataturk UniversityAbgeschlossen
-
Bezmialem Vakif UniversityRekrutierungAkuter Schmerz | OpioidgebrauchTruthahn
-
Ankara UniversityThe Scientific and Technological Research Council of TurkeyAbgeschlossenThorakotomie | Präventive Analgesie | Erector Spina Planblock | Nozizeptionslevel-Index (NoL)Truthahn
-
Firat UniversityRekrutierungSchmerzen im unteren RückenTruthahn
-
Ankara UniversityAbgeschlossenSchmerzen, postoperativ | Anästhesie | Nervenblockade | Thoraxchirurgie, videoassistiertTürkei (türkiye)
-
Kahramanmaras Sutcu Imam UniversityAbgeschlossen