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

2. august 2026 oppdatert av: 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.

Studieoversikt

Detaljert beskrivelse

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

Intervensjonell

Registrering (Antatt)

60

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

      • Tanta, Egypt, 31527
        • Rekruttering
        • Tanta University Hospital
    • Gharbia Governorate
      • Tanta, Gharbia Governorate, Egypt, 31527
        • Rekruttering
        • Tanta University Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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
Andre navn:
  • Arm 1
Aktiv 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Postoperative quality of recovery
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Postoperative pain score
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

20. juni 2026

Primær fullføring (Antatt)

1. desember 2026

Studiet fullført (Antatt)

1. januar 2027

Datoer for studieregistrering

Først innsendt

9. juni 2026

Først innsendt som oppfylte QC-kriteriene

9. juni 2026

Først lagt ut (Faktiske)

15. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. august 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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

IPD-delingstidsramme

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

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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