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临床试验/NCT07647367
NCT07647367招募中不适用

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

Tanta University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年6月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
2

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • • 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

研究组 & 干预措施

subtransverse interligamentary plane block

Experimental

Patients will receive ultrasound-guided subtransverse interligamentary plane block with local anesthetic mixture (20 mL 0.25% bupivacaine, 100 micrograms of fentanyl (2ml))

干预措施: Subtransverse interligamentary plane block (STIL) (Procedure)

Thoracic paravertebral block

Active Comparator

Patients will receive ultrasound- guided thoracic paravertebral block with local anesthetic mixture (20 mL 0.25% bupivacaine, 100 micrograms of fentanyl (2ml))

干预措施: Thoracic paravertebral block (TPVB) (Procedure)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mai Salah Salem

lecturer of anesthesia, SIC and pain medicine

Tanta University

研究点 (2)

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