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Quality of Recovery (QoR-15)NCT07647367

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

A study testing Subtransverse interligamentary plane block (STIL) and Thoracic paravertebral block (TPVB) in people with Quality of Recovery (QoR-15) and Modified Radical Mastectomy, run by Tanta University at 2 sites in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years, women only
What is being tested?
Subtransverse interligamentary plane block (STIL) and Thoracic paravertebral block (TPVB)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesEgypt
Study dates
20 Jun 2026to Jan 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Mai Salah Salem, MD anesthesia, SIC contact

01061107658 ext. 002

mai.salah@med.tanta.edu.eg

Egypt2 sites, 2 recruiting

  • Tanta university hospital

    Tanta, Gharbia Governorate, 31527

    Recruiting

  • Tanta university hospital

    Tanta, 31527

    Recruiting

Other trials in Egypt

About this study

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

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.

Read the detailed description

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.

Being tested
Subtransverse interligamentary plane block (STIL), Thoracic paravertebral block (TPVB)
Keywords
subtransverse interligamentary plane block, modified radical mastectomy, quality of recovery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Subtransverse interligamentary plane block (STIL)Procedure or surgery

    Also called Arm 1

    Patients will receieve u;trasound guided subtransverse interligamentary plane block

  • Thoracic paravertebral block (TPVB)Procedure or surgery

    Patients will receieve ultrasound guided thoracic paravertebral block

Study groups in NCT07647367
Study groupRoleWhat they receive
subtransverse interligamentary plane blockExperimentalPatients will receive ultrasound-guided subtransverse interligamentary plane block with local anesthetic mixture (20 mL 0.25% bupivacaine, 100 micrograms of fentanyl (2ml))
Receives: Procedure: Subtransverse interligamentary plane block (STIL)
Thoracic paravertebral blockActive comparatorPatients will receive ultrasound- guided thoracic paravertebral block with local anesthetic mixture (20 mL 0.25% bupivacaine, 100 micrograms of fentanyl (2ml))
Receives: Procedure: Thoracic paravertebral block (TPVB)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative quality of recovery

    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.

    Measured: It will be measured 24 hours after surgery

Secondary outcomes (6)

  1. Postoperative pain score

    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.

    Measured: It will be measured at rest and during arm movement at 0,2,6,12,24 hours postoperatively

  2. Time to first rescue analgesia

    Time interval from the end of surgery until need of rescue analgesia

    Measured: Postoperatively the time interval from the end of surgery until need of rescue analgesia will be recorded

  3. Total postoperative opioid consumption in the first 24 hours

    Total postoperative opioid consumption in the first 24 hours will be recorded

    Measured: Total needed postoperative opioid dosing during the first 24 hours will recorded

  4. Incidence of postoperative nausea and vomiting

    Postoperative incidence of postoperative nausea and vomiting will be recorded during the first 24 hours

    Measured: Postoperative incidence of postoperative nausea and vomiting will be recorded during the first 24 hours

  5. The degree of patient satisfaction

    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"

    Measured: it will be recorded postoperatively and 24 hours after surgery

  6. Block performance time

    Block performance time from the start of space visualization by ultrasound until the end of local anesthetic injection will be recorded

    Measured: Block performance time from the start of space visualization by ultrasound until the end of local anesthetic injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2026
  2. Study start20 Jun 2026
  3. Primary completionDec 2026 (estimated)
  4. Study completionJan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07647367
Sponsor's protocol ID
36265PR77/5/26
Status last verified
Jun 2026
First submitted
9 Jun 2026
Last updated
4 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The data will be available upon a reasonable request from the corresponding author

Publications

  • 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 33818764

Questions about this trial

What is this clinical trial studying?

A study testing Subtransverse interligamentary plane block (STIL) and Thoracic paravertebral block (TPVB) in people with Quality of Recovery (QoR-15) and Modified Radical Mastectomy, run by Tanta University at 2 sites in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mai Salah Salem, MD anesthesia, SIC (01061107658 ext. 002, mai.salah@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative quality of recovery (time frame: It will be measured 24 hours after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07647367, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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