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Subtransverse Interligamentary Block Versus Paravertebral Block for Quality of Recovery After Mastectomy

2 augustus 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

60

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Egypte
      • Tanta, Egypte, 31527
        • Werving
        • Tanta University Hospital
    • Gharbia Governorate
      • Tanta, Gharbia Governorate, Egypte, 31527
        • Werving
        • Tanta University Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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))
Procedure: Subtransverse interligamentary plane block (STIL)
Patients will receieve u;trasound guided subtransverse interligamentary plane block
Andere namen:
  • Arm 1
Actieve vergelijker: 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))
Procedure: Thoracic paravertebral block (TPVB)
Patients will receieve ultrasound guided thoracic paravertebral block

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Postoperative quality of recovery
Tijdsspanne: It will be measured 24 hours after surgery

Postoperative quality of recovery assessed using the Quality of Recovery-15 questionnaire which provides a global score of recovery after anesthesia and surgery by evaluating pain, comfort, emotions, independence, and support.

The total score ranges from 0 to 150. Higher score = better recovery.
It will be measured 24 hours after surgery

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Postoperative pain score
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Tanta University

Publicaties en nuttige links

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Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

20 juni 2026

Primaire voltooiing (Geschat)

1 december 2026

Studie voltooiing (Geschat)

1 januari 2027

Studieregistratiedata

Eerst ingediend

9 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

9 juni 2026

Eerst geplaatst (Werkelijk)

15 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

4 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

2 augustus 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • 36265PR77/5/26

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

The data will be available upon a reasonable request from the corresponding author

IPD-tijdsbestek voor delen

The data will be available upon a reasonable request from the corresponding author after the end of the study for 1 year

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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 .

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