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

Официальное название

Ultrasound-Guided Subtransverse Interligamentary Plane Block Versus Thoracic Paravertebral Block for Quality of Recovery After Modified Radical Mastectomy: A Randomized Non-Inferiority Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Subtransverse interligamentary plane block (STIL)
  Patients will receieve u;trasound guided subtransverse interligamentary plane block
• Процедура Thoracic paravertebral block (TPVB)
  Patients will receieve ultrasound guided thoracic paravertebral block

Первичные конечные точки

• Postoperative quality of recovery [Срок оценки: It will be measured 24 hours after surgery]

Вторичные конечные точки (6)

• Postoperative pain score [Срок оценки: It will be measured at rest and during arm movement at 0,2,6,12,24 hours postoperatively]
• Time to first rescue analgesia [Срок оценки: 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 [Срок оценки: Total needed postoperative opioid dosing during the first 24 hours will recorded]
• Incidence of postoperative nausea and vomiting [Срок оценки: Postoperative incidence of postoperative nausea and vomiting will be recorded during the first 24 hours]
• The degree of patient satisfaction [Срок оценки: it will be recorded postoperatively and 24 hours after surgery]
• Block performance time [Срок оценки: Block performance time from the start of space visualization by ultrasound until the end of local anesthetic injection]

Критерии участия

Критерии включения

• 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

Критерии исключения

• • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Египет · 2 центра

• Tanta university hospital — Tanta
• Tanta university hospital — Tanta

Публикации

• 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. PMID 31744747
• 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. PMID 31476624
• 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. PMID 32172551
• 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. PMID 31280100
• 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. PMID 33818764

Идентификаторы

NCT: NCT07647367 · 36265PR77/5/26

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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