Subtransverse Interligamentary Block vs Paravertebral Block for Quality of Recovery After Mastectomy
Official title: Ultrasound-Guided Subtransverse Interligamentary Plane Block Versus Thoracic Paravertebral Block for Quality of Recovery After Modified Radical Mastectomy: A Randomized Non-Inferiority Trial
Run by Tanta University · NCT07647367 · Data updated 2026-11-12
This study tests whether the STIL plane block can match the recovery quality after unilateral modified radical mastectomy compared with the thoracic paravertebral block in adult women.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | Women only |
| Enrollment | 60 (estimated) |
| Sponsor | Tanta University Academic / other |
| Locations | 2 sites (Tanta, Gharbia Governorate and 1 other locations) |
| Status | Recruiting |
| Started | June 20, 2026 |
| Main results expected | December 2026 |
| Study ends | January 2027 |
| Registry record updated | August 4, 2026 |
| Trial ID | NCT07647367 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adult female patients aged 18–65 with ASA I–III scheduled for unilateral modified radical mastectomy under general anesthesia and able to complete QoR-15.
✕Probably not a fit
Patients with contraindications to regional blocks, significant comorbidities, or intraoperative complications requiring ICU care may not experience benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective, randomized, double-blinded non-inferiority trial will enroll 60 adult women undergoing unilateral modified radical mastectomy under general anesthesia at Tanta University Hospitals over six months. Participants will receive either the Subtransverse interligamentary (STIL) plane block or a thoracic paravertebral block to manage postoperative pain, with QoR-15 used to measure recovery quality. The study aims to determine if STIL provides recovery outcomes not worse than TPVB while potentially reducingTechnical risks and complexity associated with paravertebral techniques. Outcomes will inform whether STIL is a viable alternative for regional anesthesia in breast surgery. Safety monitoring will capture adverse events and block-related complications.
Why it matters
Potential benefit: If successful, STIL could offer a simpler, potentially safer option that achieves similar recovery quality as TPVB after mastectomy.
How similar studies have gone: Prior work suggests regional blocks can reduce opioid needs, but direct non-inferiority data comparing STIL to TPVB in this setting is limited, making this trial exploratory.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Tanta university hospital
Tanta, Gharbia Governorate, Egypt Recruiting -
Tanta university hospital
Tanta, Egypt Recruiting
Study contacts
- Study coordinator: Mai Salah Salem, MD anesthesia, SIC
- Email: mai.salah@med.tanta.edu.eg
- Phone: 01061107658
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.